Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2021-12-01
2022-02-21
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
1. Group 1 - received a face-to-face based peer-led intervention
2. Group 2 - received an online based peer-led intervention
TREATMENT
NONE
Study Groups
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Face to face Friendship Group
8-week face-to-face peer-led intervention to support their mental health
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).
Online Friendship Group
8 week online peer-led intervention to support their mental health
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Meet the clinical threshold during Stage 1 screening
* Adults over the age of 18
Exclusion Criteria
* In receipt of additional specialist psychological therapy
* Unable to give informed consent
18 Years
ALL
Yes
Sponsors
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University College Dublin
OTHER
Exceed Worldwide
UNKNOWN
Queen's University, Belfast
OTHER
Responsible Party
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Dr Paul Best
Director
Locations
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Exceed Worldwide (DPO)
Phnom Penh, , Cambodia
Countries
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Other Identifiers
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028_2021
Identifier Type: -
Identifier Source: org_study_id
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