xml: <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/NCT05986747</url>
    </required_header>
    <id_info>
      <org_study_id>PACTvCBT</org_study_id>
      <nct_id>NCT05986747</nct_id>
    </id_info>
    <brief_title>Feasibility and Acceptability Trial of a Video Based CBT Guided Self Help Intervention for People With Low Literacy</brief_title>
    <acronym>VCBT</acronym>
    <official_title>Feasibility and Acceptability Trial of a Video Based CBT Guided Self Help Intervention for People With no or Low Literacy: A Study From a Lower Middle-income Country.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pakistan Association of Cognitive Therapists</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pakistan Association of Cognitive Therapists</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study aimed to assess the feasibility, acceptability, and preliminary efficacy of a&#xD;
        video-based CBT guided self-help intervention 'Khushi or Khatoon' to treat anxiety and&#xD;
        depression.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cognitive Behaviour Therapy (CBT) is now included in the National Treatment Guidelines in the&#xD;
        UK. However, little progress has been made in its delivery in developing countries. Limited&#xD;
        resources for the delivery of services and their concentration in big cities have&#xD;
        implications for the choice of mode of delivery of treatment. A range of methods are needed&#xD;
        to deliver treatment starting from self-help to more specialist interventions. Various CBT&#xD;
        based self-help materials have been assessed and shown to be effective in the West . The&#xD;
        effectiveness of a Culturally adapted CBT (CaCBT) based guided self-help has been reported,&#xD;
        supervised by carers, against care as usual in patients with depression, who attend secondary&#xD;
        care in Pakistan .&#xD;
  &#xD;
        However, CBT requires a person to be literate, especially for guided self-help or self-help.&#xD;
        Pakistan has a literacy rate (ability to read or write) of 58%. An estimated 67% of children&#xD;
        study up to primary level (years 1-5) and an estimated 43% have achieved secondary education&#xD;
        (up to year 12). These are mostly people from low socio-economic backgrounds who are less&#xD;
        likely to suffer from mental health problems such as depression and anxiety. In order to&#xD;
        overcome this barrier a video intervention based on self-help intervention is developed. This&#xD;
        study aims at testing the feasibility, acceptability and preliminary effectiveness of this&#xD;
        intervention.&#xD;
  &#xD;
        This will be a rater-blind RCT to evaluate the feasibility and acceptability of video-based&#xD;
        guided self-help in addition to treatment as usual (TAU) compared with the waitlist and TAU&#xD;
        in Pakistan. This study will employ a pre-post measure and parallel design. It will be&#xD;
        conducted from March 2023 to August 2023. Participants who met the inclusion criteria will be&#xD;
        randomly allocated to one of the groups, i.e. CBT video plus TAU (intervention group) or&#xD;
        waitlist plus TAU (control group) in a 1:1 ratio.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">September 24, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 24, 2023</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>Participants who met inclusion criteria will be randomly allocated to one of the groups, i.e. CBT video plus TAU (intervention group) or waitlist plus TAU (control group) in a 1:1 ratio.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility and acceptability trial of a video based CBT guided self-help intervention.</measure>
      <time_frame>12 weeks</time_frame>
      <description>Feasibility and acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants. Additionally clients satisfaction scale will be used to gather information on acceptability. At the end of the intervention, participants will be asked by RAs to describe their experience. They will be asked about to name the sessions that they found the most helpful or unhelpful, and to provide suggestions to improve the intervention. Those participants who completed less than five of seven modules will be considered drop-outs.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical Measures</measure>
      <time_frame>12 weeks</time_frame>
      <description>The Hospital Anxiety and Depression Scale (HADS) will be used to measure Anxiety and Depression. The HADS is a rating scale consisting of 14 items, Each of the items is scored on a 4-point Likert scale from 0 (not present) to 3 (considerable). The sum of the individual items provides subscale scores on the HADS-D and the HADS-A, which may range between 0 and 21. A cut-off point of ≥8 for each of the constituent subscales is used to indicate probable caseness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functioning and Disability</measure>
      <time_frame>12 weeks</time_frame>
      <description>The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) will measure the functioning and disability. It covers 6 Domains of Functioning. the scores assigned to each of the items - &quot;none&quot; (0), &quot;mild&quot; (1) &quot;moderate&quot; (2), &quot;severe&quot; (3) and &quot;extreme&quot; (4) - are summed.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the experimental group Video based CBT guided self help intervention will be provided</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>In the control group, the patients screened for depression or anxiety received treatment as usual (TAU). TAU consisted of standard care under the responsible family physician. TAU in Pakistan largely consists of pharmacological treatment with anti-depressant medication and follow-up in an outpatient clinic.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Video-based CBT guided self-help Interventions</intervention_name>
      <description>Seven modules were developed from the corresponding modules of self help. Each video was of 3-5 minutes duration. Each week 2-3 videos will be sent to participants through secure WhatsApp connection. Participants received daily reminders in the form of short pre-recorded audio messages through whatsapp.&#xD;
  Trained RAs will provide guidance as well as technical assistance during the intervention period. They will call participants once a week for 15 minutes. This call will include, feedback from previous session, explanation of current week and discussion on home work assignments.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Individuals aged 18 to 65 years&#xD;
  &#xD;
            2. without schooling&#xD;
  &#xD;
            3. able to use a smartphone&#xD;
  &#xD;
            4. Owning a smartphone or a personal computer with a reliable internet connection&#xD;
  &#xD;
            5. Score of 8 or higher on Hospital Anxiety and Depression Scale-Depression or Anxiety&#xD;
               Scales&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Substance use disorder according to DSM-5 criteria as determined by primary care&#xD;
               clinician&#xD;
  &#xD;
            2. Significant cognitive impairment (for example, profound learning disability or&#xD;
               dementia) as determined by primary care clinician&#xD;
  &#xD;
            3. Active psychosis as determined by their primary care clinician&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Farooq Naeem</last_name>
      <role>Principal Investigator</role>
      <affiliation>PACT</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Farooq Naeem</last_name>
      <phone>+16137706890</phone>
      <email>farooqnaeem7@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Pakistan Association of Cognitive Therapists</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Taj Magsi</last_name>
        <phone>00923233914614</phone>
        <email>tajmagsi2017@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Farooq Naeem</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>CBT</keyword>
    <keyword>Self-help intervention</keyword>
    <keyword>anxiety, depression</keyword>
    <keyword>RCT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986747
  org study id: PACTvCBT
  nct id: NCT05986747
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to assess the feasibility, acceptability, and preliminary efficacy of a
        video-based CBT guided self-help intervention 'Khushi or Khatoon' to treat anxiety and
        depression.
  Cognitive Behaviour Therapy (CBT) is now included in the National Treatment Guidelines in the
        UK. However, little progress has been made in its delivery in developing countries. Limited
        resources for the delivery of services and their concentration in big cities have
        implications for the choice of mode of delivery of treatment. A range of methods are needed
        to deliver treatment starting from self-help to more specialist interventions. Various CBT
        based self-help materials have been assessed and shown to be effective in the West . The
        effectiveness of a Culturally adapted CBT (CaCBT) based guided self-help has been reported,
        supervised by carers, against care as usual in patients with depression, who attend secondary
        care in Pakistan .
  
        However, CBT requires a person to be literate, especially for guided self-help or self-help.
        Pakistan has a literacy rate (ability to read or write) of 58%. An estimated 67% of children
        study up to primary level (years 1-5) and an estimated 43% have achieved secondary education
        (up to year 12). These are mostly people from low socio-economic backgrounds who are less
        likely to suffer from mental health problems such as depression and anxiety. In order to
        overcome this barrier a video intervention based on self-help intervention is developed. This
        study aims at testing the feasibility, acceptability and preliminary effectiveness of this
        intervention.
  
        This will be a rater-blind RCT to evaluate the feasibility and acceptability of video-based
        guided self-help in addition to treatment as usual (TAU) compared with the waitlist and TAU
        in Pakistan. This study will employ a pre-post measure and parallel design. It will be
        conducted from March 2023 to August 2023. Participants who met the inclusion criteria will be
        randomly allocated to one of the groups, i.e. CBT video plus TAU (intervention group) or
        waitlist plus TAU (control group) in a 1:1 ratio.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants who met inclusion criteria will be randomly allocated to one of the groups, i.e. CBT video plus TAU (intervention group) or waitlist plus TAU (control group) in a 1:1 ratio.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Feasibility and acceptability trial of a video based CBT guided self-help intervention.
  time frame: 12 weeks
  description: Feasibility and acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants. Additionally clients satisfaction scale will be used to gather information on acceptability. At the end of the intervention, participants will be asked by RAs to describe their experience. They will be asked about to name the sessions that they found the most helpful or unhelpful, and to provide suggestions to improve the intervention. Those participants who completed less than five of seven modules will be considered drop-outs.
  measure: Clinical Measures
  time frame: 12 weeks
  description: The Hospital Anxiety and Depression Scale (HADS) will be used to measure Anxiety and Depression. The HADS is a rating scale consisting of 14 items, Each of the items is scored on a 4-point Likert scale from 0 (not present) to 3 (considerable). The sum of the individual items provides subscale scores on the HADS-D and the HADS-A, which may range between 0 and 21. A cut-off point of ≥8 for each of the constituent subscales is used to indicate probable caseness.
  measure: Functioning and Disability
  time frame: 12 weeks
  description: The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) will measure the functioning and disability. It covers 6 Domains of Functioning. the scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed.
  arm group label: Experimental Group
  arm group type: Experimental
  description: In the experimental group Video based CBT guided self help intervention will be provided
  arm group label: Control Group
  arm group type: No Intervention
  description: In the control group, the patients screened for depression or anxiety received treatment as usual (TAU). TAU consisted of standard care under the responsible family physician. TAU in Pakistan largely consists of pharmacological treatment with anti-depressant medication and follow-up in an outpatient clinic.
  intervention type: Behavioral
  intervention name: Video-based CBT guided self-help Interventions
  description: Seven modules were developed from the corresponding modules of self help. Each video was of 3-5 minutes duration. Each week 2-3 videos will be sent to participants through secure WhatsApp connection. Participants received daily reminders in the form of short pre-recorded audio messages through whatsapp.
  Trained RAs will provide guidance as well as technical assistance during the intervention period. They will call participants once a week for 15 minutes. This call will include, feedback from previous session, explanation of current week and discussion on home work assignments.
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Farooq Naeem
  role: Principal Investigator
  affiliation: PACT
  last name: Farooq Naeem
  phone: +16137706890
  email: farooqnaeem7@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Depression
  sharing ipd: No