Friendship Group Intervention Development in Cambodia

Not Applicable

Completed

• Conditions: Mental Health; Distress, Emotional; Worry
• Interventions: Behavioral: Friendship Group

• Registration Number: NCT05725707
• Lead Sponsor: Queen's University, Belfast

Brief Summary

A Friendship Group (FG's) (n= 4) will be delivered over an 8-week period (December 2021 - January 2022) to individuals who met the clinical distress threshold as per Kessler-10 score. FG's were offered face-to-face in Phnom Penh (n= 2) and online via Zoom (n= 2). Trained, community support workers and Prosthetists' from the Cambodian School of Prosthetics and Orthotics delivered FG's each week.

Detailed Description

Using a mixed methods design, the research team developed and implemented an 8-week peer-led intervention (known as a Friendship Group (FG) for Cambodian adults with physical disabilities using both face-to-face and online delivery methods.

Weekly Friendship Groups (n= 4) will be delivered over an 8-week period (December 2021 - January 2022) to individuals who met the clinical threshold as per Kessler-10 score (further details published elsewhere - blinded for review). FG's were offered face-to-face in Phnom Penh (n= 2) and online via Zoom (n= 2). Trained, community support workers and Prosthetists' from the Cambodian School of Prosthetics and Orthotics delivered FG's each week and followed the same four part structure described below. Prior to the first online session, each individual was asked to take part in a one-to-one orientation session to the platform to ensure that they could access the system without any issues. Participants were also reimbursed with costs for attending FG's (e.g. taxi fares for face-to-face or internet data for online groups). All those who had consented to receive communications were sent a weekly text message reminder 24 hours prior to the next FG meeting. All sessions were delivered in the local language (Khmer).

All participants in the study completed a screening survey to determine suitability. This included some basic socio-demographic information as well a series of validated psychometric scales described elsewhere.

Statistical Analysis

The data were screened for missing values and any error cases, such as extreme outliers. There were no missing values or error cases on any of the outcomes. The Wilcoxon Signed-Rank test was used to assess changes in pre-post scores for psychological distress, PTSD, worry, rumination and facets of mindfulness. With relatively small group sample sizes, differences between group allocations could confound intervention outcome measurement and it is therefore important in such circumstances to compare baseline differences between groups during the analysis

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-21
• Study First Submitted: 2023-01-24
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-10
• Last Update Submitted: 2023-02-10
• Study First Posted: 2023-02-13
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Patients and prospective patients attending Cambodian School of Prosthetics and Orthotics
• Meet the clinical threshold during Stage 1 screening
• Adults over the age of 18

Exclusion Criteria

• Actively suicidal
• In receipt of additional specialist psychological therapy
• Unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face to face Friendship Group	Friendship Group	8-week face-to-face peer-led intervention to support their mental health
Online Friendship Group	Friendship Group	8 week online peer-led intervention to support their mental health

Primary Outcome Measures

Name	Time	Method
Kessler-10	8 weeks	The primary outcome measure was Kessler-10 which is well suited to the Cambodian context and has been translated into Khmer and validated (38). Kessler-10 measures psychological distress and scoring ranges are as follows - likely to be well (score \< 20), likely to have a mild distress (score = 20-24), likely to have moderate distress (score = 25-29) and likely to have a severe distress (score ≥ 30)

Secondary Outcome Measures

Name	Time	Method
Primary Care Screen	8 weeks	The Primary Care Screen is a five-item clinician administered screen that identifies individuals with probable PTSD. It has been used widely in primary care settings and begins by asking the individual whether they have been involved in any potentially traumatic event. Validation studies have demonstrated that answering 'yes' to three out of five questions is optimally sensitive to probable PTSD.
Pathological Worry	8-weeks	Pathological Worry: The 3-item Penn State Worry Questionnaire The 3-item Penn State Worry Questionnaire issued to measure pathological worry. The scale has comparable internal consistency and validity to the longer 16-item. Scores range from 5 (min) to 15 (max).

Trial Locations

Locations (1)

Exceed Worldwide (DPO); 🇰🇭 Phnom Penh, Cambodia