<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03288506</url>
  </required_header>
  <id_info>
    <org_study_id>R4773SES(DES)</org_study_id>
    <nct_id>NCT03288506</nct_id>
  </id_info>
  <brief_title>Developing E-health Services (DES): The Feasibility and Acceptability of Video-conferencing for Adults With Depression</brief_title>
  <acronym>DES</acronym>
  <official_title>Developing E-health Services (DES): The Feasibility and Acceptability of Group Based Video-conferencing for Adults With Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University, Belfast</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AWARE NI</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northern Ireland Public Health Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University, Belfast</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression impacts 1 in 5 people in the United Kingdom and is a significant risk factor for&#xD;
      self-harming behaviours and suicide. Research has shown that those experiencing depression&#xD;
      may feel embarrassed about seeking help from a health professional and ultimately decide not&#xD;
      to seek support at all. This project seeks to give those people an alternative option to&#xD;
      face-to-face support by developing a new online service using video conferencing technology.&#xD;
      In previous studies, this technology has shown to be beneficial in treating a number of&#xD;
      mental health problems. It may also be less expensive to run. However, as no widely available&#xD;
      services of this type exist in the UK the full extent of potential benefits is unknown. The&#xD;
      project seeks to answer the following questions:&#xD;
&#xD;
        -  What is the likely interest in video conferencing services for depression?&#xD;
&#xD;
        -  Which groups of people are likely to use the service?&#xD;
&#xD;
        -  How much will this service cost?&#xD;
&#xD;
        -  How much change is likely to occur when receiving therapy via video conferencing?&#xD;
&#xD;
      In order to answer these questions, Queens University Belfast are collaborating with AWARE&#xD;
      NI, the national depression charity for Northern Ireland. Recruitment of participants who are&#xD;
      interested in the service and delivery of the video conferencing support groups will be&#xD;
      through AWARE NI. Results will be compared from groups that receive the video-conferencing&#xD;
      service and those who are on a waiting list. Participants in both groups will be asked to&#xD;
      complete surveys and take part in interviews before and after the therapy takes place. The&#xD;
      study will have two main phases:&#xD;
&#xD;
      Phase 1: The development and in-house testing of an intervention protocol tailored towards&#xD;
      Video Conferencing (VC) based delivery of current face-to-face peer support services. This&#xD;
      will include interviews with facilitators, staff and current AWARE NI service users and&#xD;
      observations of face to face groups.&#xD;
&#xD;
      Phase 2: Delivery of an 8-week group based VC support service for adults with depression. A&#xD;
      between groups design comparing the intervention group and a waiting list control group will&#xD;
      be used. Outcome measures will be recorded at baseline, week eight and six months using&#xD;
      validated measures. Qualitative data in the form of interviews and fieldwork observations&#xD;
      will also be gathered during this 8-week period.&#xD;
&#xD;
      Results will be used to inform development of a larger trial to test the effectiveness of&#xD;
      group based video conferencing for adults with depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Around a fifth (19%) of the UK adult population has experienced depression or depressive&#xD;
      symptoms. The overall direct and indirect costs of treating mental illness, such as&#xD;
      depression, are estimated at £105 billion per annum. As much as 80% of mental health care&#xD;
      takes place in G.P surgeries or hospitals, putting increased strain on existing services and&#xD;
      increasing pressure to find suitable alternatives. One UK based RCT investigating technology&#xD;
      as a remote intervention for physical illness reported a 15% reduction in A&amp;E visits, a 20%&#xD;
      reduction in emergency admissions and an 8% reduction in tariff costs. Systematic reviews of&#xD;
      Video-Conferencing (VC) have also shown reduced costs in relation to home care and access to&#xD;
      on-call hospital specialists.&#xD;
&#xD;
      There is growing evidence to suggest that individuals will firstly go online for health&#xD;
      information before seeking professional advice. As much as 4.5% of all internet searches are&#xD;
      for health information accounting for approximately 1 out of every 20 search queries on&#xD;
      Google. Those who seek health information online may also wish to access services however,&#xD;
      the quality of interactive support online is questionable. A recent Cochrane review of&#xD;
      interactive telemedicine has shown evidence of the effectiveness of VC based therapy for&#xD;
      mental health issues. The current Secretary of State for Health has also supported the use of&#xD;
      Skype technology as part of a 'radical redevelopment' of health services. This is in tandem&#xD;
      with the launch of Northern Ireland's eHealth strategy in March 2016, adding to a number of&#xD;
      policy documents suggesting this technology has the potential to increase access, lower costs&#xD;
      and promote early intervention.&#xD;
&#xD;
      In spite of this evidence base, VC services for mental health are not widely available. As&#xD;
      such, the full risks and benefits for clinical purposes are unknown. Several studies have&#xD;
      shown the mental health benefits of VC as comparable with face-to-face therapy. However, the&#xD;
      acceptability of this approach may depend on factors, such as age and technical competence.&#xD;
      After reviewing the outcomes of VC based treatment for clients with bulimia, asserted &quot;the&#xD;
      distance and space provided by video therapy may have helped these clients to engage in&#xD;
      treatment to a greater extent than would have been possible face-to face&quot;. VC has shown to be&#xD;
      effective in the treatment of mental health conditions as well as increasing engagement for&#xD;
      groups who would otherwise struggle to do so using face-to-face services. VC has the&#xD;
      potential to increase access to services, target hard-to-reach groups and reduce G.P and&#xD;
      hospital waiting times by providing alternative support mechanisms. Given the ubiquitous&#xD;
      nature of online technologies, services are easily available and accessible which may enable&#xD;
      preventative processes to occur sooner.&#xD;
&#xD;
      This study will address the feasibility and acceptability of group based video-conferencing&#xD;
      support groups for adults with depression. Findings will inform the design and development of&#xD;
      a randomised controlled trial.&#xD;
&#xD;
      Aims &amp; objectives To test the acceptability and feasibility of delivering a peer led support&#xD;
      group intervention for depression using VC technology.&#xD;
&#xD;
        1. To gather data sufficient to undertake a power calculation to determine the number of&#xD;
           participants needed for a full scale RCT.&#xD;
&#xD;
        2. To explore the acceptability of randomisation within a future RCT design.&#xD;
&#xD;
        3. To establish suitability of recruitment methods.&#xD;
&#xD;
        4. To conduct a parallel qualitative study of the potential advantages and disadvantages of&#xD;
           VC support for depression.&#xD;
&#xD;
        5. Test measures needed for economic appraisal.&#xD;
&#xD;
        6. To gather data in relation to likely interest in the service.&#xD;
&#xD;
        7. Gather preliminary evidence of the potential of the intervention to reduce depression.&#xD;
&#xD;
      Study design and methods Study design will be informed by the development and feasibility&#xD;
      stages of the Medical Research Council (MRC) Framework for complex interventions using mixed&#xD;
      methods. The project will involve two core phases. Phase one will focus on intervention&#xD;
      development and in-house testing of the intervention protocol. This will include interviews&#xD;
      and observations with facilitators, staff and current AWARE NI service users. Phase two will&#xD;
      involve delivery of an eight week group based VC support service for adults with depression.&#xD;
      Outcome measures for phase two will be recorded at baseline, week eight and at six months.&#xD;
      Participants will include adults (18+) seeking support for depression. Facilitators will be&#xD;
      AWARE NI staff and/or volunteers who are trained and experienced in delivering face to face&#xD;
      group support meetings.&#xD;
&#xD;
      Phase 1: Intervention development, training and in-house testing During Phase 1, focus groups&#xD;
      and interviews will be conducted with current service users to explore issues, such as the&#xD;
      benefits of a VC support service, the barriers to accessing such a service and any&#xD;
      suggestions regarding its current development. Member(s) of the research team at QUB will&#xD;
      also observe face to face support groups.&#xD;
&#xD;
      In house testing will be conducted with AWARE NI staff to identify and address practical&#xD;
      issues for example in using equipment (for example setting up cameras/speakers), logging in&#xD;
      to the video conferencing site (Google Hangouts) as hosts and instructions needed to support&#xD;
      staff. QUB researchers will observe staff and facilitators using the technology and&#xD;
      interviews with staff and facilitators after testing.&#xD;
&#xD;
      Subsequently, a protocol will be produced for facilitators to complement the training&#xD;
      programme. The manual is expected to include guidance around practical issues e.g. logging in&#xD;
      as facilitators; checks that should be made at the start of each session (such as internet&#xD;
      connection); alerting members as to when sessions will be beginning; checking sound issues;&#xD;
      and informing the group if a member of the research team is observing the VC session.&#xD;
      Guidance will also relate to dealing with drop outs and maintaining attendance records.&#xD;
&#xD;
      Current service users, staff and facilitators will be recruited through a convenience&#xD;
      sampling method. Participant Information Sheets and Consent forms will be provided to group&#xD;
      members through their group facilitators.&#xD;
&#xD;
      Phase 2: Intervention delivery and evaluation Approximately 4 - 6 VC groups (6-8 participants&#xD;
      per group) will be delivered on a weekly basis for eight weeks. Groups will be facilitated&#xD;
      peer facilitators from AWARE NI who are trained and experienced in delivering face to face&#xD;
      support groups. Groups will be hosted securely through Google Hangouts. The online group will&#xD;
      mirror the structure and format of face-to-face groups. Evaluation of groups will involve&#xD;
      collection of outcome measures using validated instruments, interviews with group&#xD;
      members/facilitators and observations of groups (described below).&#xD;
&#xD;
      Recruitment Advice was taken from the research team's statistician (Dr Chris Cardwell) and&#xD;
      the Northern Ireland Clinical Trials Unit on sample sizes required for the feasibility study.&#xD;
      As such, a total of 100 participants will be sought for this study.&#xD;
&#xD;
      Online support groups will be advertised as a new service by AWARE NI on the home page of the&#xD;
      organisations website. Invitation to participate will be through an introductory page. The&#xD;
      advertisement will specify that AWARE NI are expanding their services to include a new online&#xD;
      support group service and that QUB will be working with AWARE NI to evaluate this new&#xD;
      service. If participants are interested in the service and in taking part in the evaluation,&#xD;
      they will be invited to click on a link that will lead to further information (the&#xD;
      Participant Information Sheet). Consent will be obtained online in the first instance as a&#xD;
      necessary step in registration and reaffirmed verbally during the VC sessions.&#xD;
&#xD;
      Registration will close once the target of 100 registers persons has been reached. Those who&#xD;
      attempt to register after this will be advised that capacity has been reached and that they&#xD;
      can add their name and contact details to a waiting list to be informed of when the service&#xD;
      will become available again. This will include basic information only e.g. first name, email,&#xD;
      age and gender. These individuals will also offered face to face support by AWARE NI outside&#xD;
      of the study. The number of persons registering interest overall will be recorded as a&#xD;
      measure of demand for the service and will inform the recruitment strategy of the larger RCT&#xD;
      study.&#xD;
&#xD;
      The registration process will involve completion of several baseline measures including&#xD;
      demographic information (first name, date of birth/age, gender, postcode, and information on&#xD;
      any services currently receiving or accessed within the last year) and completion of&#xD;
      validated measures of health status (see appendix A).&#xD;
&#xD;
      Randomisation Randomisation will take place following registration and completion of baseline&#xD;
      measures (see section below). Each participant will be assigned a unique individual number&#xD;
      and a simple random sampling procedure will be performed using online software available at&#xD;
      http://www.randomization.com. This will result in approximately 40 participants being invited&#xD;
      to join the VC intervention. The decision on this number was based on organisational capacity&#xD;
      to deliver VC groups concurrently. The remaining registered participants will act as a&#xD;
      waiting list control group (to be offered the intervention at the end of the study). A block&#xD;
      randomisation procedure will be applied. This will involve randomly allocating in blocks of&#xD;
      size 5 (3 to treatment and 2 to control).&#xD;
&#xD;
      Data collection Outcome measures will be recorded at baseline, week eight and six months. The&#xD;
      research team will explore the appropriateness of the following validated instruments;&#xD;
      Patient Health Questionnaire (PHQ-9), EQ-5D-5L measures of health outcomes and an adapted&#xD;
      version of the Client Service Receipt Inventory (CSRI) for economic appraisal. Completion of&#xD;
      questionnaires at each stage is expected to take approximately 5-10 minutes in total. These&#xD;
      measurements have shown previous validity and reliability in similar studies. Feasibility&#xD;
      will be assessed using depression outcomes; ability to recruit and retain; and fidelity (i.e.&#xD;
      consistency of implementation across groups). Acceptability will be assessed by comparing&#xD;
      attendance across groups, dropout rates and using through the qualitative methods (interviews&#xD;
      and observations) specified to explore (1) reasons for taking part; and (2) user&#xD;
      satisfaction.&#xD;
&#xD;
      Next steps&#xD;
&#xD;
      The study will inform the design and development of a large scale Randomised Controlled Trial&#xD;
      to test the effectiveness of conducting a peer led support group intervention for depression&#xD;
      in adults using VC technology including:&#xD;
&#xD;
        1. To investigate the effectiveness of VC based support in comparison to face-to-face&#xD;
           support for reducing depression in adults&#xD;
&#xD;
        2. To conduct a multi-site economic appraisal of the costs and outcomes of VC support for&#xD;
           depression.&#xD;
&#xD;
      Collaborators at AWARE and project advisors at Mindtech will advise the research team on&#xD;
      potential UK partner organisations for the main NETS study. To date, Action on Depression&#xD;
      (Scotland) and Depression Alliance (England) have expressed interest and support for the main&#xD;
      NETS application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2016</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire - PHQ-9</measure>
    <time_frame>Six months (not collected)</time_frame>
    <description>Depression Measure&#xD;
PHQ-9 scores &gt; 10 had a sensitivity of 88% and a specificity of 88% for Major Depressive Disorder.&#xD;
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (range of 0-27)&#xD;
Internal consistency of the PHQ-9 has been shown to be high with Cronbach alphas of .86 and .89.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Google Hangout (VC) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receive peer led support for depression via Google Hangouts for 8-weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waiting list</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Google Hangout (VC) group</intervention_name>
    <description>Feasibility and acceptability of online peer support groups for adults with depression. Groups will be delivered using video-conferencing technology (Google Hangouts).</description>
    <arm_group_label>Google Hangout (VC) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older, adults with depression (not required to have a formal diagnosis to&#xD;
             participate), not currently an AWARE NI service user or accessed AWARE NI services in&#xD;
             the past 12 months, a resident of Northern Ireland and not actively suicidal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Actively suicidal, live outside Northern Ireland, currently accessing AWARE NI&#xD;
             services or have accessed within the previous 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Best, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University, Belfast</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AWARE NI</name>
      <address>
        <city>Belfast</city>
        <state>Antrim</state>
        <zip>BT15 2GG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Armfield NR, Gray LC, Smith AC. Clinical use of Skype: a review of the evidence base. J Telemed Telecare. 2012 Apr;18(3):125-7. doi: 10.1258/jtt.2012.SFT101. Epub 2012 Feb 23.</citation>
    <PMID>22362829</PMID>
  </reference>
  <reference>
    <citation>Best, P., Foye, U., Taylor, B., Hazlett, D., &amp; Manktelow, R. (2013). Online interactive suicide support services: Quality and accessibility. Mental Health Review Journal, 18(4), 226-239.</citation>
  </reference>
  <reference>
    <citation>Best, P., Manktelow, R., &amp; Taylor, BJ. (2014). Social Work and Social Media: Online Help-Seeking and the Mental Well-Being of Adolescent Males. British Journal of Social Work. (advanced access) http://doi.org/10.1093/bjsw/bcu130</citation>
  </reference>
  <reference>
    <citation>Chong J, Moreno F. Feasibility and acceptability of clinic-based telepsychiatry for low-income Hispanic primary care patients. Telemed J E Health. 2012 May;18(4):297-304. doi: 10.1089/tmj.2011.0126. Epub 2012 Mar 16.</citation>
    <PMID>22424078</PMID>
  </reference>
  <reference>
    <citation>Centre for Mental Health (2010). The economic and social costs of mental health problems in 2009/10. Accessed 4th December 2015 from http://www.centreformentalhealth.org.uk/economic-and-social-costs</citation>
  </reference>
  <reference>
    <citation>De Las Cuevas C, Arredondo MT, Cabrera MF, Sulzenbacher H, Meise U. Randomized clinical trial of telepsychiatry through videoconference versus face-to-face conventional psychiatric treatment. Telemed J E Health. 2006 Jun;12(3):341-50. doi: 10.1089/tmj.2006.12.341.</citation>
    <PMID>16796502</PMID>
  </reference>
  <reference>
    <citation>Department Of Health. (2014). Five Year Forward View, Retrieved July, 8, 2015 from https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf</citation>
  </reference>
  <reference>
    <citation>Department of Health, Social Services and Public Safety. (2011a). Transforming your care: Review of health and social care in Northern Ireland. Retrieved July, 10, 2015 from http://www.dhsspsni.gov.uk/transforming-your-care-review-of-hsc-ni-final-report.pdf</citation>
  </reference>
  <reference>
    <citation>Flodgren G, Rachas A, Farmer AJ, Inzitari M, Shepperd S. Interactive telemedicine: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2015 Sep 7;2015(9):CD002098. doi: 10.1002/14651858.CD002098.pub2.</citation>
    <PMID>26343551</PMID>
  </reference>
  <reference>
    <citation>Hollis C, Morriss R, Martin J, Amani S, Cotton R, Denis M, Lewis S. Technological innovations in mental healthcare: harnessing the digital revolution. Br J Psychiatry. 2015 Apr;206(4):263-5. doi: 10.1192/bjp.bp.113.142612.</citation>
    <PMID>25833865</PMID>
  </reference>
  <reference>
    <citation>Morahan-Martin JM. How internet users find, evaluate, and use online health information: a cross-cultural review. Cyberpsychol Behav. 2004 Oct;7(5):497-510. doi: 10.1089/cpb.2004.7.497.</citation>
    <PMID>15667044</PMID>
  </reference>
  <reference>
    <citation>Simpson, S., Bell, L., Britton, P., Mitchell, D., Morrow, E., Johnston, L. A.,. . . Brebner, J. (2006). Does video therapy work? A single case series of bulimic disorders. European Eating Disorders Review, 14, 226-241.doi:10.1002/erv.686</citation>
  </reference>
  <reference>
    <citation>The Google Corporation. (2015). A remedy for your health-related questions: health info in the Knowledge Graph. Accessed December 14th 2015 at http://googleblog.blogspot.co.uk/2015/02/health-info-knowledge-graph.html.</citation>
  </reference>
  <reference>
    <citation>Wade VA, Karnon J, Elshaug AG, Hiller JE. A systematic review of economic analyses of telehealth services using real time video communication. BMC Health Serv Res. 2010 Aug 10;10:233. doi: 10.1186/1472-6963-10-233.</citation>
    <PMID>20696073</PMID>
  </reference>
  <reference>
    <citation>Yuen EK, Herbert JD, Forman EM, Goetter EM, Juarascio AS, Rabin S, Goodwin C, Bouchard S. Acceptance based behavior therapy for social anxiety disorder through videoconferencing. J Anxiety Disord. 2013 May;27(4):389-97. doi: 10.1016/j.janxdis.2013.03.002. Epub 2013 Apr 6.</citation>
    <PMID>23764124</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <results_first_submitted>November 22, 2021</results_first_submitted>
  <results_first_submitted_qc>August 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 25, 2023</results_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University, Belfast</investigator_affiliation>
    <investigator_full_name>Dr Paul Best</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03288506/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Google Hangout (VC) Group</title>
          <description>This group receive peer led support for depression via Google Hangouts for 8-weeks&#xD;
Google Hangout (VC) group: Feasibility and acceptability of online peer support groups for adults with depression. Groups will be delivered using video-conferencing technology (Google Hangouts).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Descriptive statistics taken at baseline for PHQ-9 Retention is study declined rapidly after initial enrolment which meant that waiting list control was abandoned. As such, no-one entered control group</population>
      <group_list>
        <group group_id="B1">
          <title>Google Hangout (VC) Group</title>
          <description>This group receive peer led support for depression via Google Hangouts for 8-weeks&#xD;
Google Hangout (VC) group: Feasibility and acceptability of online peer support groups for adults with depression. Groups will be delivered using video-conferencing technology (Google Hangouts).</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>This group would remain on waiting list to receive intervention at a late date&#xD;
Note: due to low retention the waiting group was not feasible and therefore results reported are intervention group only (e.g. the researchers offered intervention to those from both groups)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.1" spread="5.9"/>
                    <measurement group_id="B3" value="18.1" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Health Questionnaire (PHQ-9)</title>
          <description>Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe&#xD;
Internal consistency of the PHQ-9 has been shown to be high with Cronbach alphas of .86 and .89.&#xD;
PHQ-9 scores &gt; 10 had a sensitivity of 88% and a specificity of 88% for Major Depressive Disorder&#xD;
Scores range from 0-27</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.1" spread="5.9"/>
                    <measurement group_id="B3" value="18.1" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Health Questionnaire - PHQ-9</title>
        <description>Depression Measure&#xD;
PHQ-9 scores &gt; 10 had a sensitivity of 88% and a specificity of 88% for Major Depressive Disorder.&#xD;
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (range of 0-27)&#xD;
Internal consistency of the PHQ-9 has been shown to be high with Cronbach alphas of .86 and .89.</description>
        <time_frame>Six months (not collected)</time_frame>
        <population>Outcome Measure data not collected due to low study retention immediate postvention (8-weeks) and 6 months</population>
        <group_list>
          <group group_id="O1">
            <title>Google Hangout (VC) Group</title>
            <description>This group receive peer led support for depression via Google Hangouts for 8-weeks&#xD;
Google Hangout (VC) group: Feasibility and acceptability of online peer support groups for adults with depression. Groups will be delivered using video-conferencing technology (Google Hangouts).</description>
          </group>
          <group group_id="O2">
            <title>Waiting List Control Group</title>
            <description>Waiting list</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire - PHQ-9</title>
          <description>Depression Measure&#xD;
PHQ-9 scores &gt; 10 had a sensitivity of 88% and a specificity of 88% for Major Depressive Disorder.&#xD;
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (range of 0-27)&#xD;
Internal consistency of the PHQ-9 has been shown to be high with Cronbach alphas of .86 and .89.</description>
          <population>Outcome Measure data not collected due to low study retention immediate postvention (8-weeks) and 6 months</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion, an average of 10 months - September 2017 - June 2018</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Google Hangout (VC) Group</title>
          <description>This group receive peer led support for depression via Google Hangouts for 8-weeks&#xD;
Google Hangout (VC) group: Feasibility and acceptability of online peer support groups for adults with depression. Groups will be delivered using video-conferencing technology (Google Hangouts).</description>
        </group>
        <group group_id="E2">
          <title>Waiting List Control Group</title>
          <description>Waiting list&#xD;
Note that waiting list control group did was not implemented due to insufficient numbers</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Paul Best</name_or_title>
      <organization>Queen's University Belfast</organization>
      <phone>0289097 ext 3256</phone>
      <email>p.best@qub.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03288506
org study id: R4773SES(DES)
nct id: NCT03288506
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Depression impacts 1 in 5 people in the United Kingdom and is a significant risk factor for
      self-harming behaviours and suicide. Research has shown that those experiencing depression
      may feel embarrassed about seeking help from a health professional and ultimately decide not
      to seek support at all. This project seeks to give those people an alternative option to
      face-to-face support by developing a new online service using video conferencing technology.
      In previous studies, this technology has shown to be beneficial in treating a number of
      mental health problems. It may also be less expensive to run. However, as no widely available
      services of this type exist in the UK the full extent of potential benefits is unknown. The
      project seeks to answer the following questions:

        -  What is the likely interest in video conferencing services for depression?

        -  Which groups of people are likely to use the service?

        -  How much will this service cost?

        -  How much change is likely to occur when receiving therapy via video conferencing?

      In order to answer these questions, Queens University Belfast are collaborating with AWARE
      NI, the national depression charity for Northern Ireland. Recruitment of participants who are
      interested in the service and delivery of the video conferencing support groups will be
      through AWARE NI. Results will be compared from groups that receive the video-conferencing
      service and those who are on a waiting list. Participants in both groups will be asked to
      complete surveys and take part in interviews before and after the therapy takes place. The
      study will have two main phases:

      Phase 1: The development and in-house testing of an intervention protocol tailored towards
      Video Conferencing (VC) based delivery of current face-to-face peer support services. This
      will include interviews with facilitators, staff and current AWARE NI service users and
      observations of face to face groups.

      Phase 2: Delivery of an 8-week group based VC support service for adults with depression. A
      between groups design comparing the intervention group and a waiting list control group will
      be used. Outcome measures will be recorded at baseline, week eight and six months using
      validated measures. Qualitative data in the form of interviews and fieldwork observations
      will also be gathered during this 8-week period.

      Results will be used to inform development of a larger trial to test the effectiveness of
      group based video conferencing for adults with depression.
Around a fifth (19%) of the UK adult population has experienced depression or depressive
      symptoms. The overall direct and indirect costs of treating mental illness, such as
      depression, are estimated at £105 billion per annum. As much as 80% of mental health care
      takes place in G.P surgeries or hospitals, putting increased strain on existing services and
      increasing pressure to find suitable alternatives. One UK based RCT investigating technology
      as a remote intervention for physical illness reported a 15% reduction in A&E visits, a 20%
      reduction in emergency admissions and an 8% reduction in tariff costs. Systematic reviews of
      Video-Conferencing (VC) have also shown reduced costs in relation to home care and access to
      on-call hospital specialists.

      There is growing evidence to suggest that individuals will firstly go online for health
      information before seeking professional advice. As much as 4.5% of all internet searches are
      for health information accounting for approximately 1 out of every 20 search queries on
      Google. Those who seek health information online may also wish to access services however,
      the quality of interactive support online is questionable. A recent Cochrane review of
      interactive telemedicine has shown evidence of the effectiveness of VC based therapy for
      mental health issues. The current Secretary of State for Health has also supported the use of
      Skype technology as part of a 'radical redevelopment' of health services. This is in tandem
      with the launch of Northern Ireland's eHealth strategy in March 2016, adding to a number of
      policy documents suggesting this technology has the potential to increase access, lower costs
      and promote early intervention.

      In spite of this evidence base, VC services for mental health are not widely available. As
      such, the full risks and benefits for clinical purposes are unknown. Several studies have
      shown the mental health benefits of VC as comparable with face-to-face therapy. However, the
      acceptability of this approach may depend on factors, such as age and technical competence.
      After reviewing the outcomes of VC based treatment for clients with bulimia, asserted "the
      distance and space provided by video therapy may have helped these clients to engage in
      treatment to a greater extent than would have been possible face-to face". VC has shown to be
      effective in the treatment of mental health conditions as well as increasing engagement for
      groups who would otherwise struggle to do so using face-to-face services. VC has the
      potential to increase access to services, target hard-to-reach groups and reduce G.P and
      hospital waiting times by providing alternative support mechanisms. Given the ubiquitous
      nature of online technologies, services are easily available and accessible which may enable
      preventative processes to occur sooner.

      This study will address the feasibility and acceptability of group based video-conferencing
      support groups for adults with depression. Findings will inform the design and development of
      a randomised controlled trial.

      Aims & objectives To test the acceptability and feasibility of delivering a peer led support
      group intervention for depression using VC technology.

        1. To gather data sufficient to undertake a power calculation to determine the number of
           participants needed for a full scale RCT.

        2. To explore the acceptability of randomisation within a future RCT design.

        3. To establish suitability of recruitment methods.

        4. To conduct a parallel qualitative study of the potential advantages and disadvantages of
           VC support for depression.

        5. Test measures needed for economic appraisal.

        6. To gather data in relation to likely interest in the service.

        7. Gather preliminary evidence of the potential of the intervention to reduce depression.

      Study design and methods Study design will be informed by the development and feasibility
      stages of the Medical Research Council (MRC) Framework for complex interventions using mixed
      methods. The project will involve two core phases. Phase one will focus on intervention
      development and in-house testing of the intervention protocol. This will include interviews
      and observations with facilitators, staff and current AWARE NI service users. Phase two will
      involve delivery of an eight week group based VC support service for adults with depression.
      Outcome measures for phase two will be recorded at baseline, week eight and at six months.
      Participants will include adults (18+) seeking support for depression. Facilitators will be
      AWARE NI staff and/or volunteers who are trained and experienced in delivering face to face
      group support meetings.

      Phase 1: Intervention development, training and in-house testing During Phase 1, focus groups
      and interviews will be conducted with current service users to explore issues, such as the
      benefits of a VC support service, the barriers to accessing such a service and any
      suggestions regarding its current development. Member(s) of the research team at QUB will
      also observe face to face support groups.

      In house testing will be conducted with AWARE NI staff to identify and address practical
      issues for example in using equipment (for example setting up cameras/speakers), logging in
      to the video conferencing site (Google Hangouts) as hosts and instructions needed to support
      staff. QUB researchers will observe staff and facilitators using the technology and
      interviews with staff and facilitators after testing.

      Subsequently, a protocol will be produced for facilitators to complement the training
      programme. The manual is expected to include guidance around practical issues e.g. logging in
      as facilitators; checks that should be made at the start of each session (such as internet
      connection); alerting members as to when sessions will be beginning; checking sound issues;
      and informing the group if a member of the research team is observing the VC session.
      Guidance will also relate to dealing with drop outs and maintaining attendance records.

      Current service users, staff and facilitators will be recruited through a convenience
      sampling method. Participant Information Sheets and Consent forms will be provided to group
      members through their group facilitators.

      Phase 2: Intervention delivery and evaluation Approximately 4 - 6 VC groups (6-8 participants
      per group) will be delivered on a weekly basis for eight weeks. Groups will be facilitated
      peer facilitators from AWARE NI who are trained and experienced in delivering face to face
      support groups. Groups will be hosted securely through Google Hangouts. The online group will
      mirror the structure and format of face-to-face groups. Evaluation of groups will involve
      collection of outcome measures using validated instruments, interviews with group
      members/facilitators and observations of groups (described below).

      Recruitment Advice was taken from the research team's statistician (Dr Chris Cardwell) and
      the Northern Ireland Clinical Trials Unit on sample sizes required for the feasibility study.
      As such, a total of 100 participants will be sought for this study.

      Online support groups will be advertised as a new service by AWARE NI on the home page of the
      organisations website. Invitation to participate will be through an introductory page. The
      advertisement will specify that AWARE NI are expanding their services to include a new online
      support group service and that QUB will be working with AWARE NI to evaluate this new
      service. If participants are interested in the service and in taking part in the evaluation,
      they will be invited to click on a link that will lead to further information (the
      Participant Information Sheet). Consent will be obtained online in the first instance as a
      necessary step in registration and reaffirmed verbally during the VC sessions.

      Registration will close once the target of 100 registers persons has been reached. Those who
      attempt to register after this will be advised that capacity has been reached and that they
      can add their name and contact details to a waiting list to be informed of when the service
      will become available again. This will include basic information only e.g. first name, email,
      age and gender. These individuals will also offered face to face support by AWARE NI outside
      of the study. The number of persons registering interest overall will be recorded as a
      measure of demand for the service and will inform the recruitment strategy of the larger RCT
      study.

      The registration process will involve completion of several baseline measures including
      demographic information (first name, date of birth/age, gender, postcode, and information on
      any services currently receiving or accessed within the last year) and completion of
      validated measures of health status (see appendix A).

      Randomisation Randomisation will take place following registration and completion of baseline
      measures (see section below). Each participant will be assigned a unique individual number
      and a simple random sampling procedure will be performed using online software available at
      http://www.randomization.com. This will result in approximately 40 participants being invited
      to join the VC intervention. The decision on this number was based on organisational capacity
      to deliver VC groups concurrently. The remaining registered participants will act as a
      waiting list control group (to be offered the intervention at the end of the study). A block
      randomisation procedure will be applied. This will involve randomly allocating in blocks of
      size 5 (3 to treatment and 2 to control).

      Data collection Outcome measures will be recorded at baseline, week eight and six months. The
      research team will explore the appropriateness of the following validated instruments;
      Patient Health Questionnaire (PHQ-9), EQ-5D-5L measures of health outcomes and an adapted
      version of the Client Service Receipt Inventory (CSRI) for economic appraisal. Completion of
      questionnaires at each stage is expected to take approximately 5-10 minutes in total. These
      measurements have shown previous validity and reliability in similar studies. Feasibility
      will be assessed using depression outcomes; ability to recruit and retain; and fidelity (i.e.
      consistency of implementation across groups). Acceptability will be assessed by comparing
      attendance across groups, dropout rates and using through the qualitative methods (interviews
      and observations) specified to explore (1) reasons for taking part; and (2) user
      satisfaction.

      Next steps

      The study will inform the design and development of a large scale Randomised Controlled Trial
      to test the effectiveness of conducting a peer led support group intervention for depression
      in adults using VC technology including:

        1. To investigate the effectiveness of VC based support in comparison to face-to-face
           support for reducing depression in adults

        2. To conduct a multi-site economic appraisal of the costs and outcomes of VC support for
           depression.

      Collaborators at AWARE and project advisors at Mindtech will advise the research team on
      potential UK partner organisations for the main NETS study. To date, Action on Depression
      (Scotland) and Depression Alliance (England) have expressed interest and support for the main
      NETS application.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient Health Questionnaire - PHQ-9
time frame: Six months (not collected)
description: Depression Measure
PHQ-9 scores > 10 had a sensitivity of 88% and a specificity of 88% for Major Depressive Disorder.
Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe (range of 0-27)
Internal consistency of the PHQ-9 has been shown to be high with Cronbach alphas of .86 and .89.
arm group label: Google Hangout (VC) group
arm group type: Experimental
description: This group receive peer led support for depression via Google Hangouts for 8-weeks
arm group label: Waiting list control group
arm group type: No Intervention
description: Waiting list
intervention type: Behavioral
intervention name: Google Hangout (VC) group
description: Feasibility and acceptability of online peer support groups for adults with depression. Groups will be delivered using video-conferencing technology (Google Hangouts).
arm group label: Google Hangout (VC) group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Best, PhD
role: Principal Investigator
affiliation: Queen's University, Belfast
facility: 
country: United Kingdom
citation: Armfield NR, Gray LC, Smith AC. Clinical use of Skype: a review of the evidence base. J Telemed Telecare. 2012 Apr;18(3):125-7. doi: 10.1258/jtt.2012.SFT101. Epub 2012 Feb 23.
PMID: 22362829
citation: Best, P., Foye, U., Taylor, B., Hazlett, D., & Manktelow, R. (2013). Online interactive suicide support services: Quality and accessibility. Mental Health Review Journal, 18(4), 226-239.
citation: Best, P., Manktelow, R., & Taylor, BJ. (2014). Social Work and Social Media: Online Help-Seeking and the Mental Well-Being of Adolescent Males. British Journal of Social Work. (advanced access) http://doi.org/10.1093/bjsw/bcu130
citation: Chong J, Moreno F. Feasibility and acceptability of clinic-based telepsychiatry for low-income Hispanic primary care patients. Telemed J E Health. 2012 May;18(4):297-304. doi: 10.1089/tmj.2011.0126. Epub 2012 Mar 16.
PMID: 22424078
citation: Centre for Mental Health (2010). The economic and social costs of mental health problems in 2009/10. Accessed 4th December 2015 from http://www.centreformentalhealth.org.uk/economic-and-social-costs
citation: De Las Cuevas C, Arredondo MT, Cabrera MF, Sulzenbacher H, Meise U. Randomized clinical trial of telepsychiatry through videoconference versus face-to-face conventional psychiatric treatment. Telemed J E Health. 2006 Jun;12(3):341-50. doi: 10.1089/tmj.2006.12.341.
PMID: 16796502
citation: Department Of Health. (2014). Five Year Forward View, Retrieved July, 8, 2015 from https://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf
citation: Department of Health, Social Services and Public Safety. (2011a). Transforming your care: Review of health and social care in Northern Ireland. Retrieved July, 10, 2015 from http://www.dhsspsni.gov.uk/transforming-your-care-review-of-hsc-ni-final-report.pdf
citation: Flodgren G, Rachas A, Farmer AJ, Inzitari M, Shepperd S. Interactive telemedicine: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2015 Sep 7;2015(9):CD002098. doi: 10.1002/14651858.CD002098.pub2.
PMID: 26343551
citation: Hollis C, Morriss R, Martin J, Amani S, Cotton R, Denis M, Lewis S. Technological innovations in mental healthcare: harnessing the digital revolution. Br J Psychiatry. 2015 Apr;206(4):263-5. doi: 10.1192/bjp.bp.113.142612.
PMID: 25833865
citation: Morahan-Martin JM. How internet users find, evaluate, and use online health information: a cross-cultural review. Cyberpsychol Behav. 2004 Oct;7(5):497-510. doi: 10.1089/cpb.2004.7.497.
PMID: 15667044
citation: Simpson, S., Bell, L., Britton, P., Mitchell, D., Morrow, E., Johnston, L. A.,. . . Brebner, J. (2006). Does video therapy work? A single case series of bulimic disorders. European Eating Disorders Review, 14, 226-241.doi:10.1002/erv.686
citation: The Google Corporation. (2015). A remedy for your health-related questions: health info in the Knowledge Graph. Accessed December 14th 2015 at http://googleblog.blogspot.co.uk/2015/02/health-info-knowledge-graph.html.
citation: Wade VA, Karnon J, Elshaug AG, Hiller JE. A systematic review of economic analyses of telehealth services using real time video communication. BMC Health Serv Res. 2010 Aug 10;10:233. doi: 10.1186/1472-6963-10-233.
PMID: 20696073
citation: Yuen EK, Herbert JD, Forman EM, Goetter EM, Juarascio AS, Rabin S, Goodwin C, Bouchard S. Acceptance based behavior therapy for social anxiety disorder through videoconferencing. J Anxiety Disord. 2013 May;27(4):389-97. doi: 10.1016/j.janxdis.2013.03.002. Epub 2013 Apr 6.
PMID: 23764124
responsible party type: Principal Investigator
investigator affiliation: Queen's University, Belfast
investigator full name: Dr Paul Best
investigator title: Lecturer
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
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