The Delivery of "Doing What Matters in Times of Stress: An Illustrated Guide"

NCT04631887 | Completed DMC

• 1 other identifier: 2020.200.IRB3.080
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The feasibility study for the delivery of the "Doing What Matters in Times of Stress: An Illustrated Guide" will be carried out for Turkish and Syrian individuals with psychological stress. This feasibility study's sample will be adult Turkish and the Syrian refugees. The informed consent form and screening questionnaire of the feasibility study will be sent to the participants who have given this approval and 128 (64 Turkish and 64 Syrian) participants who meet the inclusion criteria will be included in the feasibility study. The psychological problems will be measured twice, before and after the intervention.

Conditions

Stress; Quality of Life; Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• Change of the Patient Health Questionnaire-9 (PHQ-9) over time

  Patient Health Questionnaire-9 is a 9 item questionnaire that aims to measure the severity of depression symptoms. Each of the 9 items are scored as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate decreased functional status and increased symptom-related difficulties.

  Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)

Secondary Outcomes (5)

• Change of the General Anxiety Disorder-7 (GAD-7) over time

  Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)

• Change of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time

  Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)

• Change of the The World Health Organization Quality of Life (WHOQOL) over time

  Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)

• Change of the The General Self-Efficacy Scale over time

  Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)

• Change of the The Acceptance and Action Questionnaire (AAQ-2) over time

  Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)

Study Arms (2)

Intervention Arm: Doing What Matters in Times of Stress: An Illustrated Guide

EXPERIMENTAL

The intervention arm will receive the assigned intervention for five weeks. They will receive the intervention materials and will be called by psychologists three times (at the beginning, middle and end) during the intervention.

Behavioral: Doing What Matters in Times of Stress: An Illustrated Guide

Control Arm: Wait List

NO INTERVENTION

The control arm has no intervention. The participants in the control arm will receive the intervention after the post-assessments are completed.

Interventions

Doing What Matters in Times of Stress: An Illustrated Guide BEHAVIORAL

The "Doing What Matters in Times of Stress: An Illustrated Guide" is a booklet that is developed by World Health Organization. It is a stress management booklet formed to provide people skills for coping with stress and adversity. The booklet has accompanying audio exercises.

Intervention Arm: Doing What Matters in Times of Stress: An Illustrated Guide

Eligibility Criteria

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

You may qualify if:

• Being 18 years or above
• Being literate
• Being a Turkish citizen or a Syrian refugee
• Scoring 15 or above on Kessler Psychological Distress Scale (K10)

You may not qualify if:

• Imminent suicidal risk
• Being illiterate

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Dong L, Bouey J. Public Mental Health Crisis during COVID-19 Pandemic, China. Emerg Infect Dis. 2020 Jul;26(7):1616-1618. doi: 10.3201/eid2607.200407. Epub 2020 Jun 21.

  PMID: 32202993 BACKGROUND

• Epping-Jordan JE, Harris R, Brown FL, Carswell K, Foley C, Garcia-Moreno C, Kogan C, van Ommeren M. Self-Help Plus (SH+): a new WHO stress management package. World Psychiatry. 2016 Oct;15(3):295-296. doi: 10.1002/wps.20355. No abstract available.

  PMID: 27717271 BACKGROUND

• Fledderus M, Bohlmeijer ET, Pieterse ME, Schreurs KM. Acceptance and commitment therapy as guided self-help for psychological distress and positive mental health: a randomized controlled trial. Psychol Med. 2012 Mar;42(3):485-95. doi: 10.1017/S0033291711001206. Epub 2011 Jul 11.

  PMID: 21740624 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Gülşah Kurt, PhD

  Koç University

  STUDY CHAIR

• Zeynep Ilkkursun, MA

  Koç University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 17, 2020
• Study Start: November 9, 2020
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)