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CompletedNCT05725707Updated Feb 13, 2023

Friendship Group Intervention Development in Cambodia

An interventional study of Friendship Group in Mental Health, Distress, Emotional and Worry, sponsored by Queen's University, Belfast. Completed at 1 site in Cambodia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-13.

Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Dec 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Mental Health
  • Distress, Emotional
  • Worry
03

In context

Lead sponsor

Queen's University, Belfast is the lead sponsor of 113 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Actively suicidal
  • In receipt of additional specialist psychological therapy
  • Unable to give informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Active comparator
    Face to face Friendship Group

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

    Behavioral: Friendship Group

  • Active comparator
    Online Friendship Group

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

    Behavioral: Friendship Group

Interventions

  • BehavioralFriendship Group

    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).

06

What researchers measure

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)

    Time frame: 8 weeks

Secondary outcomes

  1. Primary Care Screen

    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.

    Time frame: 8 weeks

  2. Pathological Worry

    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).

    Time frame: 8-weeks

07

Study locations

1 site
  • Exceed Worldwide (DPO)
    Phnom Penh, PO.Box 122, Cambodia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05725707
Lead sponsor
Queen's University, Belfast
Collaborators
University College Dublin, Exceed Worldwide
Responsible party
Dr Paul Best (Director, Queen's University, Belfast) — Principal investigator
First posted
Feb 13, 2023
Start date
Dec 1, 2021
Primary completion
Jan 30, 2022
Completion
Feb 21, 2022
Last update
Feb 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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