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Completed

NCT Number: NCT04631887

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

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.

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Key information

Conditions

Stress Behavior Behavioral Symptoms Depression Depressive Symptoms Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koc University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    General Anxiety Disorder-7 is a 7-item questionnaire that aims to measure anxiety symptoms. Each of the 7 items are scored as 0, 1, 2, and 3 to the response categories (0 = "not at all," to 3= "nearly every day"). The total score for the seven items ranges from 0 to 21. Higher scores indicate higher levels of anxiety.

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

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

    The PTSD Checklist for DSM-5 is a 20-item questionnaire that assesses the symptoms of PTSD. In this study, a single question from each criteria of PTSD will be used. Overall four questions from PCL-5 will be assessed. Each of the 4 items are scored as 0, 1, 2, 3 and 4 (0 = "Not at all" to 4 = "Extremely"). The total score for the four items ranges from 0 to 16. Higher scores indicate higher levels of PTSD symptoms.

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

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

    The World Health Organization Quality of Life questionnaire assesses various domains of life which are physical health, psychological health, social relationships, and environment. In this study, a single question from the questionnaire will be used which will be about the general quality of life. The question is scored from 1 to 5 on a response scale (1 = "Not at all" to 5 = "Completely"). A higher score indicate higher quality of life.

  4. Change of the The General Self-Efficacy Scale over time

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

    The General Self-Efficacy Scale is a 10-item questionnaire that assesses the general sense of perceived self-efficacy. Each of the 10 items are scored as 1, 2, 3 and 4 on a response scale (1 = "Not at all true" to 4 = "Exactly true"). The total score for the four items ranges from 10 to 40. Higher scores indicate higher perceived general self-efficacy, lower scores indicate lower perceived general self-efficacy.

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

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

    The Acceptance and Action Questionnaire is a 7-item questionnaire that assesses the psychological flexibility. Each of the 7 items are scored as 1, 2, 3, 4, 5, 6 and 7 on a response scale (1 = "Never true" to 7 = "Always true"). The total score for the four items ranges from 7 to 49. Higher total scores mean less flexibility, while lower total scores mean more flexibility.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

The Feasibility Study of The Delivery of The Book From Self Help Plus: "Doing What Matters in Times of Stress: An Illustrated Guide"

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2020
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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