Clinical trial NCT04631887: The Delivery of "Doing What Matters in Times of Stress: An Illustrated Guide"
Official title: The Feasibility Study of The Delivery of The Book From Self Help Plus: "Doing What Matters in Times of Stress: An Illustrated Guide"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Quality of Life
Depressive Symptoms
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Studies about the impact of epidemics such as Severe acute respiratory syndrome (SARS) on the psychological health of individuals show that psychological problems have been observed in individuals who are affected by the epidemic. Today, studies on the effects of COVID-19 on psychological health are also available in the literature, and the results of these studies are in line with those of previous studies on epidemics.

The aim of this project is to deliver the "Doing What Matters in Times of Stress: An Illustrated Guide" that is developed by the World Health Organization within Self Help Plus (SH+) intervention to decrease their psychological problems for a feasibility study. The feasibility study for the delivery of the SH+ book will be carried out and the psychological problems of the participants will be measured twice, before and after the intervention to evaluate the results.

The most important contribution of the Project is conducting a feasibility study with the "Doing What Matters in Times of Stress: An Illustrated Guide" which will be adapted to the Turkish culture based on the determination of Turkey's current psychological status, provide a form of intervention to the Turkish psychological intervention literature and to improve the psychological status of the participants in this project.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Imminent suicidal risk
* Being illiterate

Primary outcomes:
measure: Change of the Patient Health Questionnaire-9 (PHQ-9) over time
timeFrame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Secondary outcomes:
measure: Change of the General Anxiety Disorder-7 (GAD-7) over time
timeFrame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
measure: Change of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time
timeFrame: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
measure: Change of the The World Health Organization Quality of Life (WHOQOL) over time
timeFrame: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
measure: Change of the The General Self-Efficacy Scale over time
timeFrame: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
measure: Change of the The Acceptance and Action Questionnaire (AAQ-2) over time
timeFrame: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Gülşah Kurt, PhD
role: STUDY_CHAIR
affiliation: Koç University
name: Zeynep Ilkkursun, MA
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.