Feasibility and Acceptability Trial of a Video Based CBT Guided Self Help Intervention for People With Low Literacy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Video-based CBT guided self-help Interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged 18 to 65 years without schooling able to use a smartphone Owning a smartphone or a personal computer with a reliable internet connection Score of 8 or higher on Hospital Anxiety and Depression Scale-Depression or Anxiety Scales Exclusion Criteria: Substance use disorder according to DSM-5 criteria as determined by primary care clinician Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician Active psychosis as determined by their primary care clinician

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>In the experimental group Video based CBT guided self help intervention will be provided | Behavioral: Video-based CBT guided self-help Interventions<br>* 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.<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability trial of a video based CBT guided self-help intervention. | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Measures | 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. | 12 weeks | 
| Functioning and Disability | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-help intervention, anxiety, depression, RCT, CBT