Friendship Group Intervention Development in Cambodia

Sponsor
Queen's University, Belfast (Other)
Overall Status
Completed
CT.gov ID
NCT05725707
Collaborator
University College Dublin (Other), Exceed Worldwide (Other)
41
1
2
2.7
15.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Friendship Group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups - Group 1 - received a face-to-face based peer-led intervention Group 2 - received an online based peer-led interventionTwo groups - Group 1 - received a face-to-face based peer-led intervention Group 2 - received an online based peer-led intervention
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Peer Led Friendship Group Intervention Development for Adults With Disabilities in Cambodia
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Jan 30, 2022
Actual Study Completion Date :
Feb 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Face to face Friendship Group

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

Behavioral: Friendship 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).

Active Comparator: Online Friendship Group

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

Behavioral: Friendship 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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • Actively suicidal

  • In receipt of additional specialist psychological therapy

  • Unable to give informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Exceed Worldwide (DPO) Phnom Penh Cambodia PO.Box 122

Sponsors and Collaborators

  • Queen's University, Belfast
  • University College Dublin
  • Exceed Worldwide

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Paul Best, Director, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT05725707
Other Study ID Numbers:
  • 028_2021
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 13, 2023