Clinical trial NCT05725707: Friendship Group Intervention Development in Cambodia
Official title: Peer Led Friendship Group Intervention Development for Adults With Disabilities in Cambodia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Distress, Emotional
Worry
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: Exceed Worldwide
First posted: 2023-02-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups -

1. Group 1 - received a face-to-face based peer-led intervention
2. Group 2 - received an online based peer-led intervention
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Kessler-10
timeFrame: 8 weeks
Secondary outcomes:
measure: Primary Care Screen
timeFrame: 8 weeks
measure: Pathological Worry
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Exceed Worldwide (DPO)
Study officials:
References: