NCT05986747

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Pakistan Association of Cognitive Therapists · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Depression
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-11-28
• Completion: 2023-12-10
• First posted: 2023-08-14
• Last updated: 2023-11-29

Locations

1 site across 1 country: Pakistan