Feasibility of SOLAR Group Program Among MHPSS Workers After the Earthquake

NCT06231927 | Active Not Recruiting

• 1 other identifier: 2023.371.IRB3.164
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention program is to provide the feasibility of a culturally adapted version of the SOLAR program among mental health and psychosocial support (MHPSS) workers who provide psychological or psychosocial support to the survivors of the earthquakes on February 6, 2023, in Türkiye. The main questions it aims to answer are:

• a demographic form,
• the Kessler Psychological Distress Scale (K10),
• Assessment of Suicidal Thoughts for the screening. Before the SOLAR intervention program, participants will be asked to complete:
• the Secondary Traumatic Stress Scale (STSS),
• Generalized Anxiety Disorder-7 (GAD-7),
• the Patient Health Questionnaire (PHQ-9) if they approve participation in these surveys. After collecting their pre-test scores, they will receive the SOLAR intervention program. During the program, they will be asked to participate in each session, lasting 5 weeks. After the program, they will be asked to participate process evaluation interview.

Conditions

Psychological Distress; Secondary Trauma; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Psychological Distress

  The Kessler Psychological Distress Scale (K10)

  1. approximately a week before intervention for the screening 2. at the end of the intervention 3. one month after the end of the intervention

Secondary Outcomes (3)

• Secondary traumatic stress

  1. at the beginning of the intervention 2. at the end of the intervention 3. one month after the end of the intervention

• Depression

  1. at the beginning of the intervention 2. at the end of the intervention 3. one month after the end of the intervention

• Anxiety

  1. at the beginning of the intervention 2. at the end of the intervention 3. one month after the end of the intervention

Study Arms (1)

Single arm

EXPERIMENTAL

This is an open feasibility trial with single group of individuals receiving the SOLAR intervention program.

Behavioral: The Skills for Life Adjustment and Resilience (SOLAR) program

Interventions

The Skills for Life Adjustment and Resilience (SOLAR) program BEHAVIORAL

The SOLAR program is a 5-session intervention program that aims to introduce participants necessary recovery skills after a traumatic event resulting in a subclinical distress. During the program, participants will be given workbooks including the topics for skill development for recovery and adjustment. At each session, they will discuss these topics with the study coaches.

Single arm

Eligibility Criteria

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

You may qualify if:

• at least 18 years of age
• actively working as an MHPSS worker who provides psychosocial support to the survivors of the February 6 earthquake
• having subclinical symptoms of distress (score\>20 on The Kessler Psychological Distress Scale (K10)
• no suicidal risk.

You may not qualify if:

• not approving the informed consent
• having a suicidal thought.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• O'Donnell ML, Lau W, Fredrickson J, Gibson K, Bryant RA, Bisson J, Burke S, Busuttil W, Coghlan A, Creamer M, Gray D, Greenberg N, McDermott B, McFarlane AC, Monson CM, Phelps A, Ruzek JI, Schnurr PP, Ugsang J, Watson P, Whitton S, Williams R, Cowlishaw S, Forbes D. An Open Label Pilot Study of a Brief Psychosocial Intervention for Disaster and Trauma Survivors. Front Psychiatry. 2020 Jun 26;11:483. doi: 10.3389/fpsyt.2020.00483. eCollection 2020.

  PMID: 32670099 BACKGROUND

MeSH Terms

Conditions

Compassion Fatigue; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Occupational Stress; Stress, Psychological; Mental Disorders

Study Officials

• Ceren Acartürk

  Koç University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: April 15, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All data will be kept in a locked safe for 10 years. Then, it will be deleted in an untraceable way.
• Access Criteria: The researcher and the supervisor of this study will have access to data. As mentioned, participants have different identification numbers or codes.

Locations

TU (1)