Clinical trial NCT05986747: Feasibility and Acceptability Trial of a Video Based CBT Guided Self Help Intervention for People With Low Literacy
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: CBT
Self-help intervention
anxiety, depression
RCT
Lead sponsor: Pakistan Association of Cognitive Therapists
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Individuals aged 18 to 65 years
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:

1. Substance use disorder according to DSM-5 criteria as determined by primary care clinician
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

Primary outcomes:
measure: Feasibility and acceptability trial of a video based CBT guided self-help intervention.
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Measures
timeFrame: 12 weeks
measure: Functioning and Disability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Association of Cognitive Therapists
state: Punjab
Study officials:
affiliation: PACT
name: Farooq Naeem
role: PRINCIPAL_INVESTIGATOR
References: