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

NCT05986747 | Unknown DMC

• 1 other identifier: PACTvCBT
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

CBT; Self-help intervention; anxiety, depression; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Measures

  12 weeks

• Functioning and Disability

  12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

In the experimental group Video based CBT guided self help intervention will be provided

Behavioral: Video-based CBT guided self-help Interventions

Control Group

NO INTERVENTION

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.

Interventions

Video-based CBT guided self-help Interventions BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Association of Cognitive Therapists: lead

Study Sites (1)

Pakistan Association of Cognitive Therapists

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Farooq Naeem

  PACT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farooq Naeem

CONTACT

+16137706890; farooqnaeem7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: November 28, 2023
• Study Completion: December 10, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)