Friendship Group Intervention Development in Cambodia

NCT05725707 | Completed

• 1 other identifier: 028_2021
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health; Distress, Emotional; Worry

Outcome Measures

Primary Outcomes (1)

• Kessler-10

  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)

  8 weeks

Secondary Outcomes (2)

• Primary Care Screen

  8 weeks

• Pathological Worry

  8-weeks

Study Arms (2)

Face to face Friendship Group

ACTIVE COMPARATOR

8-week face-to-face peer-led intervention to support their mental health

Behavioral: Friendship Group

Online Friendship Group

ACTIVE COMPARATOR

8 week online peer-led intervention to support their mental health

Behavioral: Friendship Group

Interventions

Friendship Group BEHAVIORAL

Whether face-to-face or online delivery, each FG session followed the same broad format - (1) Group meditative exercise and reminder of group agreement (10 mins); (2) Check in with support group members and main session (50mins); (3) Summary of group discussion and homework activity planning (10mins); (4) Final group meditative exercise and closing of group (10mins). Session length was up to 80 minutes (see table 2) and each facilitator was provided with a manual describing each section as well as some hints and tips to promote discussion and engagement. While all FG's would follow this structure, group members would drive the content (particularly during Step 2).

Face to face Friendship Group; Online Friendship Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University College Dublin: collaborator
• Exceed Worldwide: collaborator

Study Sites (1)

Exceed Worldwide (DPO)

Phnom Penh, PO.Box 122, Cambodia

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Two groups - 1. Group 1 - received a face-to-face based peer-led intervention 2. Group 2 - received an online based peer-led intervention

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 13, 2023
• Study Start: December 1, 2021
• Primary Completion: January 30, 2022
• Study Completion: February 21, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)