<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/NCT03295032</url>
  </required_header>
  <id_info>
    <org_study_id>Cardiff University</org_study_id>
    <nct_id>NCT03295032</nct_id>
  </id_info>
  <brief_title>A Mixed-methods Evaluation of an Adapted Acceptance and Commitment Therapy (ACT) Group for Stroke Survivors</brief_title>
  <official_title>A Mixed-methods Evaluation of an Adapted Acceptance and Commitment Therapy (ACT) Group for Stroke Survivors and Their Carers: ACTivate Your Life After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiff University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cwm Taf University Health Board (NHS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cardiff and Vale University Health Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aneurin Bevan University Health Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Bristol NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospitals Bristol and Weston NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BASF</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiff University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is one of the main causes of acquired adult disability in the UK. Many psychological&#xD;
      problems can also occur post-stroke; this has a marked impact on health service usage. As&#xD;
      such, there is an outstanding need to increase and improve psychological resources within&#xD;
      stroke services.&#xD;
&#xD;
      The investigators proposed to adapt and evaluate the effectiveness of an acceptance and&#xD;
      commitment therapy (ACT) group intervention for adult stroke survivors and their carers. The&#xD;
      group will endeavour to promote positive adjustment and reduce levels of depression and&#xD;
      anxiety.&#xD;
&#xD;
      This study will have two parts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is one of the main causes of acquired adult disability in the UK. In England and&#xD;
      Wales, over 900,000 people are living with the chronic illness, which can cause sufferers to&#xD;
      be highly dependent on others for their care. Many psychological problems can also occur&#xD;
      including: depression, anxiety and fatigue. This has a marked impact on health service usage.&#xD;
      There is an outstanding need to increase and improve psychological resources within these&#xD;
      services.&#xD;
&#xD;
      Acceptance and Commitment Therapy (ACT) has a well-established evidence base for reducing&#xD;
      psychological distress in individuals with mental illness and physical health conditions&#xD;
      including: diabetes, chronic pain, epilepsy &amp; cancer. It is hoped that the investigators can&#xD;
      apply this same model to support stroke survivors and their carers.&#xD;
&#xD;
      The investigators propose to evaluate the effectiveness of an adapted ACT group intervention&#xD;
      for adult stroke survivors and their carers. The benefit of ACT is that it is transdiagnostic&#xD;
      therefore applicable to the very wide range of psychological problems found in carers and&#xD;
      survivors after stroke. This ACT group is a stroke adapted version of the already existing&#xD;
      'ACTivate your life' course, which is being run by the NHS for people with mental health&#xD;
      difficulties across South Wales. The course endeavours to promote positive adjustment and&#xD;
      reduce levels of depression and anxiety, using the core tenets of ACT.&#xD;
&#xD;
      This study will have two parts. Part 1: a quantitative phase evaluating the effectiveness of&#xD;
      the ACT group using outcome data in comparison to a waiting list control across three time&#xD;
      points. Part 2: A qualitative phase exploring stroke survivors experiences of the ACT group&#xD;
      and their perceptions of any change from group attendance.&#xD;
&#xD;
      PART 1:&#xD;
&#xD;
      Design: The study will employ a longitudinal randomised design using a questionnaire&#xD;
      methodology. The study will not be blind. Outcome measures will be taken pre, post and at a&#xD;
      two month follow up.&#xD;
&#xD;
      Participants and Recruitment: Participants will be recruited across five NHS University&#xD;
      Health Boards/Trusts: Cardiff and Vale University Health Board, Aneurin Bevan university&#xD;
      health board, Cwm Taf University Health Board, North Bristol NHS Trust and University&#xD;
      Hospitals Bristol NHS Foundation Trust. Bristol Area Stroke Foundation charity (BASF) will&#xD;
      also assist in the recruitment across Bristol and will host the course for all Bristol&#xD;
      participants. The individuals may be recruited at any stage of the care pathway after&#xD;
      discharge from hospital.&#xD;
&#xD;
      Potential participants will be identified by clinicians working within the stroke teams. All&#xD;
      interested participants will be provided with a course flyer, written participant information&#xD;
      sheet and consent form. Once consent has been obtained, participants will be randomly&#xD;
      allocated into the treatment group or placed on a waiting list (control group). Carer/stroke&#xD;
      survivor pairs will be allocated together. Participants who were allocated into the waiting&#xD;
      list group initially, will be offered to attend the ACT group once the first group has&#xD;
      finished and 2 month follow-up data has been collected.&#xD;
&#xD;
      The intervention group will attend a four week, 2.5 hour (maximum) psycho-educational group&#xD;
      that focuses on assisting stroke survivors and carers to learn a set of simple, and&#xD;
      teachable, techniques that focuses on changing patterns of experience and thinking. The&#xD;
      learning will involve understanding the principles of ACT via PowerPoint presentations which&#xD;
      have been adapted to include stroke specific examples and have been simplified to allow for&#xD;
      potential cognitive impairment.&#xD;
&#xD;
      Sample Size: In order for sufficient power (0.80) and using standard parameters of alpha =&#xD;
      0.05, a total sample size of between 40 - 64 participants are required in total.&#xD;
&#xD;
      Control Group: After the intervention group is finished, the waiting list group will be&#xD;
      offered the intervention which will consist of the exact same process as above.&#xD;
&#xD;
      Data Protection: Data will be anonymised with randomly allocated codes. Identifiable personal&#xD;
      data will be stored separately in a locked unit.&#xD;
&#xD;
      Analysis: A mixed model (within and between participants) MANOVA will be looking for group x&#xD;
      time interaction between the experimental and control.&#xD;
&#xD;
      PART 2:&#xD;
&#xD;
      Design: Semi-structured interviews will be conducted to explore stroke survivors' subjective&#xD;
      experiences of the ACT group. These will be conducted &gt;1 month after the group and will be&#xD;
      framed around 8 main questions. Interviews will be undertaken in consultation rooms or in the&#xD;
      participants' own home, lasting no more than 1 hour. The number of interviews conducted will&#xD;
      depend upon the length of time it takes to reach data saturation (i.e. when no new&#xD;
      information is emerging from the dataset), which is recommended for the type of qualitative&#xD;
      analysis being performed. Interviews will be audio-recorded to support the researcher with&#xD;
      transcription and data analysis. Participants will be made aware of this in advance on the&#xD;
      consent form.&#xD;
&#xD;
      Sample Size: The investigators envisage data saturation will be achieved anywhere between 12&#xD;
      - 25 participant interviews.&#xD;
&#xD;
      Sampling: Sampling will begin purposefully in the first instance to offer maximum variation&#xD;
      in stroke survivors reported experiences of the group i.e. a diverse range of participants&#xD;
      who expressed interest to partake will be interviewed. Theoretical sampling will then be used&#xD;
      for subsequent interviews, whereby participants are selected based on the emerging theory.&#xD;
&#xD;
      Recruitment: Similar to above, participants will be recruited from the University Health&#xD;
      Boards (UHBs) and BASF charity, at any stage of the care pathway following discharge.&#xD;
      Participants for this phase of the study will consist only of stroke survivors.&#xD;
&#xD;
      Data Protection: All data will be stored on a password protected and encrypted USB device for&#xD;
      the duration of the study, and will subsequently be destroyed after use. Participants will be&#xD;
      assigned a numerical identifier during transcription to protect their identity.&#xD;
&#xD;
      Analysis: Grounded Theory (GT) will be used in phase 2, for both data collection and analysis&#xD;
      which will occur simultaneously. GT aims to identify emerging themes from the data and&#xD;
      develop new, contextualised theories (i.e. &quot;grounded&quot; in the data). As such, data collected&#xD;
      after each interview will be transcribed and reviewed in an evolving process. Interview&#xD;
      questions will be revised to progressively focus on the emerging theory. This process is in&#xD;
      line with the inductive nature of the GT approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">December 29, 2016</completion_date>
  <primary_completion_date type="Actual">December 29, 2016</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>
    <intervention_model_description>Part 1: Randomised Controlled Trial with an intervention (ACT group) and Waiting List Control arm.&#xD;
Part 2: Interviews</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring a change in PHQ9 scores</measure>
    <time_frame>baseline, 4 weeks and two month follow-up</time_frame>
    <description>measure of depression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measuring a change in GAD7 scores</measure>
    <time_frame>baseline, 4 weeks and two month follow-up</time_frame>
    <description>measure of anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring a change in Warwick and Edinburgh Mental Wellbeing Scale (WEMWBS) scores</measure>
    <time_frame>baseline, 4 weeks and two month follow-up</time_frame>
    <description>measure of mental wellbeing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring a change in Adult Hope Scale (AHS) scores</measure>
    <time_frame>baseline, 4 weeks and two month follow-up</time_frame>
    <description>measure of hopefulness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring a change in EQ-5D-5L scores</measure>
    <time_frame>baseline, 4 weeks and two month follow-up</time_frame>
    <description>measure of quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Stroke</condition>
  <condition>Acceptance and Commitment Therapy</condition>
  <arm_group>
    <arm_group_label>group-based ACT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stroke survivors were randomised into group-based ACT intervention consisting of 2hr sessions for four consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waiting list control - received treatment as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance and Commitment Therapy (ACT)</intervention_name>
    <description>ACT is a psychological intervention; in this study it is being delivered as a 4-week psycho-educational group to stroke survivors and carers.&#xD;
Rather than attempting to control or ameliorate pain and suffering, ACT advocates that individuals remain open to internal private experiences (both positive and negative) and should focus on committing to a life which is congruent with their core values. Individuals learn to modify their relationship with these experiences, rather than change the experiences per se through processes such as mindfulness, acceptance and attention to values. This fundamental premise of ACT helps cultivate psychological flexibility.</description>
    <arm_group_label>group-based ACT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants must be &gt;18 years&#xD;
&#xD;
          -  Clinical diagnosis of stroke (or carers of someone who has experienced a stroke)&#xD;
&#xD;
          -  Must be able to understand English and communicate responses.&#xD;
&#xD;
          -  The target volunteer has been referred to this stroke-adapted ACT course by a&#xD;
             clinician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any other acquired brain injury e.g. traumatic brain injury,&#xD;
             encephalitis, tumours etc.&#xD;
&#xD;
          -  Patients diagnosed with a degenerative condition e.g. dementias.&#xD;
&#xD;
          -  Significant cognitive/language impairment that would prevent them from engaging with&#xD;
             the group.&#xD;
&#xD;
          -  Those experiencing severe psychotic symptoms&#xD;
&#xD;
          -  Those who are receiving other therapies, as part of a multicomponent intervention&#xD;
             which would prevent any changes specific to group psychotherapy to be estimated (with&#xD;
             the exception of drugs for anxiety and depression).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Professor Reg Morris, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cardiff University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bristol Area Stroke Foundation</name>
      <address>
        <city>Bristol</city>
        <state>England</state>
        <zip>BS13 9JN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff &amp; Vale NHS Trust</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF62 2XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cwm Taf NHS Trust</name>
      <address>
        <city>Merthyr Tydfil</city>
        <state>Wales</state>
        <zip>CF40 2LU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aneurin Bevan NHS Trust</name>
      <address>
        <city>Newport</city>
        <state>Wales</state>
        <zip>NP20 4SZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Campbell Burton CA, Murray J, Holmes J, Astin F, Greenwood D, Knapp P. Frequency of anxiety after stroke: a systematic review and meta-analysis of observational studies. Int J Stroke. 2013 Oct;8(7):545-59. doi: 10.1111/j.1747-4949.2012.00906.x. Epub 2012 Sep 27.</citation>
    <PMID>23013268</PMID>
  </reference>
  <reference>
    <citation>Constructing Grounded Theory: A practical guide through qualitative analysis Kathy Charmaz Constructing Grounded Theory: A practical guide through qualitative analysis Sage 224 pound19.99 0761973532 0761973532 [Formula: see text]. Nurse Res. 2006 Jul 1;13(4):84. doi: 10.7748/nr.13.4.84.s4.</citation>
    <PMID>27702218</PMID>
  </reference>
  <reference>
    <citation>Feros DL, Lane L, Ciarrochi J, Blackledge JT. Acceptance and Commitment Therapy (ACT) for improving the lives of cancer patients: a preliminary study. Psychooncology. 2013 Feb;22(2):459-64. doi: 10.1002/pon.2083. Epub 2011 Oct 6.</citation>
    <PMID>23382134</PMID>
  </reference>
  <reference>
    <citation>Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.</citation>
    <PMID>16300724</PMID>
  </reference>
  <reference>
    <citation>Kangas M, McDonald S. Is it time to act? The potential of acceptance and commitment therapy for psychological problems following acquired brain injury. Neuropsychol Rehabil. 2011 Apr;21(2):250-76. doi: 10.1080/09602011.2010.540920. Epub 2011 Jan 17.</citation>
    <PMID>21246445</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiff University</investigator_affiliation>
    <investigator_full_name>Rebecca Large</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03295032
org study id: Cardiff University
nct id: NCT03295032
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke is one of the main causes of acquired adult disability in the UK. Many psychological
      problems can also occur post-stroke; this has a marked impact on health service usage. As
      such, there is an outstanding need to increase and improve psychological resources within
      stroke services.

      The investigators proposed to adapt and evaluate the effectiveness of an acceptance and
      commitment therapy (ACT) group intervention for adult stroke survivors and their carers. The
      group will endeavour to promote positive adjustment and reduce levels of depression and
      anxiety.

      This study will have two parts.
Stroke is one of the main causes of acquired adult disability in the UK. In England and
      Wales, over 900,000 people are living with the chronic illness, which can cause sufferers to
      be highly dependent on others for their care. Many psychological problems can also occur
      including: depression, anxiety and fatigue. This has a marked impact on health service usage.
      There is an outstanding need to increase and improve psychological resources within these
      services.

      Acceptance and Commitment Therapy (ACT) has a well-established evidence base for reducing
      psychological distress in individuals with mental illness and physical health conditions
      including: diabetes, chronic pain, epilepsy & cancer. It is hoped that the investigators can
      apply this same model to support stroke survivors and their carers.

      The investigators propose to evaluate the effectiveness of an adapted ACT group intervention
      for adult stroke survivors and their carers. The benefit of ACT is that it is transdiagnostic
      therefore applicable to the very wide range of psychological problems found in carers and
      survivors after stroke. This ACT group is a stroke adapted version of the already existing
      'ACTivate your life' course, which is being run by the NHS for people with mental health
      difficulties across South Wales. The course endeavours to promote positive adjustment and
      reduce levels of depression and anxiety, using the core tenets of ACT.

      This study will have two parts. Part 1: a quantitative phase evaluating the effectiveness of
      the ACT group using outcome data in comparison to a waiting list control across three time
      points. Part 2: A qualitative phase exploring stroke survivors experiences of the ACT group
      and their perceptions of any change from group attendance.

      PART 1:

      Design: The study will employ a longitudinal randomised design using a questionnaire
      methodology. The study will not be blind. Outcome measures will be taken pre, post and at a
      two month follow up.

      Participants and Recruitment: Participants will be recruited across five NHS University
      Health Boards/Trusts: Cardiff and Vale University Health Board, Aneurin Bevan university
      health board, Cwm Taf University Health Board, North Bristol NHS Trust and University
      Hospitals Bristol NHS Foundation Trust. Bristol Area Stroke Foundation charity (BASF) will
      also assist in the recruitment across Bristol and will host the course for all Bristol
      participants. The individuals may be recruited at any stage of the care pathway after
      discharge from hospital.

      Potential participants will be identified by clinicians working within the stroke teams. All
      interested participants will be provided with a course flyer, written participant information
      sheet and consent form. Once consent has been obtained, participants will be randomly
      allocated into the treatment group or placed on a waiting list (control group). Carer/stroke
      survivor pairs will be allocated together. Participants who were allocated into the waiting
      list group initially, will be offered to attend the ACT group once the first group has
      finished and 2 month follow-up data has been collected.

      The intervention group will attend a four week, 2.5 hour (maximum) psycho-educational group
      that focuses on assisting stroke survivors and carers to learn a set of simple, and
      teachable, techniques that focuses on changing patterns of experience and thinking. The
      learning will involve understanding the principles of ACT via PowerPoint presentations which
      have been adapted to include stroke specific examples and have been simplified to allow for
      potential cognitive impairment.

      Sample Size: In order for sufficient power (0.80) and using standard parameters of alpha =
      0.05, a total sample size of between 40 - 64 participants are required in total.

      Control Group: After the intervention group is finished, the waiting list group will be
      offered the intervention which will consist of the exact same process as above.

      Data Protection: Data will be anonymised with randomly allocated codes. Identifiable personal
      data will be stored separately in a locked unit.

      Analysis: A mixed model (within and between participants) MANOVA will be looking for group x
      time interaction between the experimental and control.

      PART 2:

      Design: Semi-structured interviews will be conducted to explore stroke survivors' subjective
      experiences of the ACT group. These will be conducted >1 month after the group and will be
      framed around 8 main questions. Interviews will be undertaken in consultation rooms or in the
      participants' own home, lasting no more than 1 hour. The number of interviews conducted will
      depend upon the length of time it takes to reach data saturation (i.e. when no new
      information is emerging from the dataset), which is recommended for the type of qualitative
      analysis being performed. Interviews will be audio-recorded to support the researcher with
      transcription and data analysis. Participants will be made aware of this in advance on the
      consent form.

      Sample Size: The investigators envisage data saturation will be achieved anywhere between 12
      - 25 participant interviews.

      Sampling: Sampling will begin purposefully in the first instance to offer maximum variation
      in stroke survivors reported experiences of the group i.e. a diverse range of participants
      who expressed interest to partake will be interviewed. Theoretical sampling will then be used
      for subsequent interviews, whereby participants are selected based on the emerging theory.

      Recruitment: Similar to above, participants will be recruited from the University Health
      Boards (UHBs) and BASF charity, at any stage of the care pathway following discharge.
      Participants for this phase of the study will consist only of stroke survivors.

      Data Protection: All data will be stored on a password protected and encrypted USB device for
      the duration of the study, and will subsequently be destroyed after use. Participants will be
      assigned a numerical identifier during transcription to protect their identity.

      Analysis: Grounded Theory (GT) will be used in phase 2, for both data collection and analysis
      which will occur simultaneously. GT aims to identify emerging themes from the data and
      develop new, contextualised theories (i.e. "grounded" in the data). As such, data collected
      after each interview will be transcribed and reviewed in an evolving process. Interview
      questions will be revised to progressively focus on the emerging theory. This process is in
      line with the inductive nature of the GT approach.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Part 1: Randomised Controlled Trial with an intervention (ACT group) and Waiting List Control arm.
Part 2: Interviews
primary purpose: Treatment
masking: None (Open Label)
measure: Measuring a change in PHQ9 scores
time frame: baseline, 4 weeks and two month follow-up
description: measure of depression
measure: Measuring a change in GAD7 scores
time frame: baseline, 4 weeks and two month follow-up
description: measure of anxiety
measure: Measuring a change in Warwick and Edinburgh Mental Wellbeing Scale (WEMWBS) scores
time frame: baseline, 4 weeks and two month follow-up
description: measure of mental wellbeing
measure: Measuring a change in Adult Hope Scale (AHS) scores
time frame: baseline, 4 weeks and two month follow-up
description: measure of hopefulness
measure: Measuring a change in EQ-5D-5L scores
time frame: baseline, 4 weeks and two month follow-up
description: measure of quality of life
arm group label: group-based ACT
arm group type: Experimental
description: Stroke survivors were randomised into group-based ACT intervention consisting of 2hr sessions for four consecutive weeks.
arm group label: Waiting list control
arm group type: No Intervention
description: Waiting list control - received treatment as usual.
intervention type: Behavioral
intervention name: Acceptance and Commitment Therapy (ACT)
description: ACT is a psychological intervention; in this study it is being delivered as a 4-week psycho-educational group to stroke survivors and carers.
Rather than attempting to control or ameliorate pain and suffering, ACT advocates that individuals remain open to internal private experiences (both positive and negative) and should focus on committing to a life which is congruent with their core values. Individuals learn to modify their relationship with these experiences, rather than change the experiences per se through processes such as mindfulness, acceptance and attention to values. This fundamental premise of ACT helps cultivate psychological flexibility.
arm group label: group-based ACT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Professor Reg Morris, PhD
role: Study Director
affiliation: Cardiff University
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
citation: Campbell Burton CA, Murray J, Holmes J, Astin F, Greenwood D, Knapp P. Frequency of anxiety after stroke: a systematic review and meta-analysis of observational studies. Int J Stroke. 2013 Oct;8(7):545-59. doi: 10.1111/j.1747-4949.2012.00906.x. Epub 2012 Sep 27.
PMID: 23013268
citation: Constructing Grounded Theory: A practical guide through qualitative analysis Kathy Charmaz Constructing Grounded Theory: A practical guide through qualitative analysis Sage 224 pound19.99 0761973532 0761973532 [Formula: see text]. Nurse Res. 2006 Jul 1;13(4):84. doi: 10.7748/nr.13.4.84.s4.
PMID: 27702218
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responsible party type: Principal Investigator
investigator affiliation: Cardiff University
investigator full name: Rebecca Large
investigator title: Principal Investigator
mesh term: Stroke
sharing ipd: No