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

NCT ID: NCT04631887

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2021-01-29

Brief Summary

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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

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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.

Conditions

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Stress Quality of Life Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Doing What Matters in Times of Stress: An Illustrated Guide

Intervention Type 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.

Control Arm: Wait List

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Doing What Matters in Times of Stress: An Illustrated Guide

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 Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Koç University

OTHER

Sponsor Role lead

Responsible Party

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Ceren Acarturk

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülşah Kurt, PhD

Role: STUDY_CHAIR

Koç University

Zeynep Ilkkursun, MA

Role: STUDY_CHAIR

Koç University

Locations

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Koc University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32202993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27717271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21740624 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2020.200.IRB3.080

Identifier Type: -

Identifier Source: org_study_id

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