Feasibility and Acceptability Trial of a Video Based CBT Guided Self Help Intervention for People With Low Literacy
NCT ID: NCT05986747
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
14 participants
INTERVENTIONAL
2023-08-01
2023-12-10
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Experimental Group
In the experimental group Video based CBT guided self help intervention will be provided
Video-based CBT guided self-help Interventions
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.
Control Group
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.
No interventions assigned to this group
Interventions
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Video-based CBT guided self-help Interventions
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.
Eligibility Criteria
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Inclusion Criteria
2. without schooling
3. able to use a smartphone
4. Owning a smartphone or a personal computer with a reliable internet connection
5. Score of 8 or higher on Hospital Anxiety and Depression Scale-Depression or Anxiety Scales
Exclusion Criteria
2. Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician
3. Active psychosis as determined by their primary care clinician
18 Years
65 Years
ALL
No
Sponsors
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Pakistan Association of Cognitive Therapists
OTHER
Responsible Party
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Principal Investigators
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Farooq Naeem
Role: PRINCIPAL_INVESTIGATOR
PACT
Locations
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Pakistan Association of Cognitive Therapists
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Taj Magsi
Role: primary
Other Identifiers
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PACTvCBT
Identifier Type: -
Identifier Source: org_study_id