- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07357129
Stress Management Intervention for Young Turkish Women
A Psychosocial Intervention Program to Improve Stress Management Among Young Women: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This pilot study aims to evaluate the feasibility, acceptability, appropriateness, and probable effectiveness of a community-based stress management program, designed to reduce the stress levels and improve psychological well-being.
Stress is part of daily life; ability to effectively cope with stress plays a crucial role in both physical health and psychological well-being. Numerous studies have shown that effective stress management is a protective factor for physical and psychological well-being. The positive effects of stress coping skills are not limited to reducing current psychological distress; they also act as protective skills, preparing individuals for future stressors. Globally and in Türkiye, the rate of psychiatric disorders is higher among women than men. Major depression and anxiety disorders, the most common disorders around the globe, are twice as common in women as in men.
Consequently, this study aims to implement and measure the feasibility of the Self-Help Plus (SH+) program developed by the World Health Organization in the Turkish context. This intervention, which has been used among immigrants and has proven to be effective, is intended to be implemented for the first time among distressed Turkish-speaking women in Türkiye. The primary goal of the proposed pilot study is to measure its feasibility and probable effectiveness, in order to design a fully powered RCT.
The study will be conducted in Istanbul, Türkiye. Participants will be recruited through social media outlets and via snowballing. Once required number of participants who meet inclusion criteria (distressed without suicide risk) is reached (total of 60 participants), they will be randomly assigned to intervention and control groups (randomization to two arms according to 1:1 principle using an online randomization software). 30 randomly allocated participants will be divided into two groups, and will receive five sessions of SH+ (sessions are weekly, last about 90 to 120 minutes). The remaining 30 participants will be on a waitlist, and will receive the program once follow up assessments are completed. All participants will complete primary and secondary outcome measures at three time points: baseline, within one week upon completion of 5 week sessions (post assessment), and 3 months after the completion of 5 week sessions (follow-up assessment).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yasemin Sohtorik Ilkmen, Psy.D.
- Phone Number: 90 507 504 5684
- Email: sohtorik@bogazici.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being a woman
- being ages between 18 and 29
- being fluent in Turkish
- having high levels of psychological distress (scoring above 15 on the Turkish version of the Kessler Psychological Distress Scale (K-10)
Exclusion Criteria:
- having an imminent risk of suicide (measured by WHO PM+ assessment tool)
- having a diagnosis for severe mental disorder (e.g., psychotic disorders or substance dependence)
- having cognitive impairment (e.g., received a diagnosis of dementia or severe intellectual disability)
- currently receiving psychological treatment, e.g., therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Help Plus Intervention Group
This arm will receieve Self-Help Plus (SH+) intervention, which is a five-session stress management program developed by the World Health Organization (WHO).
The program is designed to be administered in a group format for maximum of 30 participants.
Facilitators are not required to be mental health professionals.
The best way to implement the program is to train non-specialists from the local communities where it will be delivered.
These community members may become facilitators following a brief training.
The program is composed of listening to pre-recorded audios along with some group discussions moderated by the facilitators.
|
Self-Help Plus (SH+): SH+ is a five-session stress management program developed by the World Health Organization (WHO).
The program is designed to be administered in a group format for maximum of 30 participants.
Facilitators are not required to be mental health professionals.
The best way to implement the program is to train non-specialists from the local communities where it will be delivered.
These community members may become facilitators following a brief training.
The program is composed of listening to pre-recorded audios along with some group discussions moderated by the facilitators.
|
|
No Intervention: Control Group
Participants in this no intervention group will serve as the control group.
Upon the completion of the study (after 3 months follow-up assessments), participants in this group will also receive the same intervention to ensure ethical considerations and promote equity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
K10
Time Frame: Baseline, within one week after the completion of 5 sessions, and 3 months after the completion of 5 sessions
|
Kessler Psychological Distress Scale (K10) is a 10-item questionnaire that aims to measure psychological distress symptoms.
Each of the 10 items are scored on a scale of 5 points (1 = "none of the time" to 5= "all of the time"), providing a total score between 10 and 50.
Higher scores indicate higher levels of psychological distress.
A Turkish version is available and will be used in the current study.
|
Baseline, within one week after the completion of 5 sessions, and 3 months after the completion of 5 sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, within one week of completion of 5 sessions, and 3 months after the completion of 5 sessions
|
PHQ-9 is a self-report measure including 9 items that aims to measure the severity of depression symptoms.
Each of the 9 items are scored on a 4 point scale (0 = "not at all," to 3= "nearly every day"), providing scores between 0 and 27.
Higher scores indicate higher level of depressive symptoms that are related with decreased functional status and increased symptom-related difficulties.
Turkish version of the PHQ-9 will be used in the current study.
|
Baseline, within one week of completion of 5 sessions, and 3 months after the completion of 5 sessions
|
|
General Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline, within one week upon completion of 5 sessions, and 3 months after completion of 5 sessions
|
GAD-7 is a self-report questionnaire that includes 7 items to measure anxiety symptoms.
Each item is scored on a 4 point scale (0 = "not at all," to 3= "nearly every day"), providing scores between 0 and 21.
Higher scores indicate higher levels of anxiety.
A Turkish version is available, and will be used in the current study.
|
Baseline, within one week upon completion of 5 sessions, and 3 months after completion of 5 sessions
|
|
World Health Organization-Five Well-Being Index (WHO-5)
Time Frame: Baseline, within one week upon completion of 5 sessions, and 3 months after completion of 5 sessions
|
Developed by WHO to measure subjective well-being (e.g., calmness and cheerfulness), the WHO-5 consists of a total of 5 questions answered on a 6-point Likert scale (0 = "at no time," to 5 = "all of the time").
Total scores range from zero to 25, higher scores indicating better well-being.
The raw total scores are multiplied by four, to generate percentage scores between 0 and 100; percentage scores below 50 are considered to indicate poor mental well-being.
The Turkish version will be used in the current study.
|
Baseline, within one week upon completion of 5 sessions, and 3 months after completion of 5 sessions
|
|
General Self Efficacy Scale (GSES)
Time Frame: Baseline, within one week upon completion of 5 sessions, and 3 months after 5 sessions
|
GSES is a self-report measure designed to assess the perceived sense of self-efficacy.
The scale consists of 10 items rated on a 4-point Likert scale (1 = "not at all true" to 4 = "exactly true"), yielding total scores ranging from 10 to 40.
Higher scores indicate higher sense of self-efficacy.
The Turkish version will be used in the current study.
|
Baseline, within one week upon completion of 5 sessions, and 3 months after 5 sessions
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, Howes MJ, Normand SL, Manderscheid RW, Walters EE, Zaslavsky AM. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003 Feb;60(2):184-9. doi: 10.1001/archpsyc.60.2.184.
- Acarturk C, Uygun E, Ilkkursun Z, Carswell K, Tedeschi F, Batu M, Eskici S, Kurt G, Anttila M, Au T, Baumgartner J, Churchill R, Cuijpers P, Becker T, Koesters M, Lantta T, Nose M, Ostuzzi G, Popa M, Purgato M, Sijbrandij M, Turrini G, Valimaki M, Walker L, Wancata J, Zanini E, White RG, van Ommeren M, Barbui C. Effectiveness of a WHO self-help psychological intervention for preventing mental disorders among Syrian refugees in Turkey: a randomized controlled trial. World Psychiatry. 2022 Feb;21(1):88-95. doi: 10.1002/wps.20939.
- World Health Organization. "Self-help plus (SH+) training manual". https://iris.who.int/bitstream/handle/10665/379110/9789240095052-eng.pdf?sequence=1 Last Retreived: 8 August 2025.
- World Health Organization. "Committing to implementation of the Global Strategy for Women's, Children's and Adolescents' Health (2016-2030)". https://iris.who.int/bitstream/handle/10665/366978/WHO-UHL-MCA-GS-23.01-eng.pdf?sequence=1, Last retreived: 8 August 2025.
- Thoits PA. Stress and health: major findings and policy implications. J Health Soc Behav. 2010;51 Suppl:S41-53. doi: 10.1177/0022146510383499.
- Sari, Y. E., Kokoglu, B., Balcioglu, H., Bilge, U., Colak, E. Unluoglu, I. 2016. "Turkish reliability of the patient health questionnaire-9", Biomedical Research-India, 27, S460-S462.
- Nolen-Hoeksema S. Sex differences in unipolar depression: evidence and theory. Psychol Bull. 1987 Mar;101(2):259-82. No abstract available.
- Koyun, A., Taşkın, L., Terzioğlu, F. 2011. "Yaşam dönemlerine göre kadın sağlığı ve ruhsal işlevler: Hemşirelik yaklaşımlarının değerlendirilmesi", Psikiyatride Güncel Yaklaşımlar, 3(1), 67-99.
- Min JA, Lee CU, Lee C. Mental health promotion and illness prevention: a challenge for psychiatrists. Psychiatry Investig. 2013 Dec;10(4):307-16. doi: 10.4306/pi.2013.10.4.307. Epub 2013 Dec 16.
- Konkan, R., Senormanci, O., Guclu, O., Aydin, E. Sungur, M. Z., 2013. "Validity and reliability study for the Turkish adaptation of the Generalized Anxiety Disorder-7 (GAD-7) scale/Yaygin Anksiyete Bozuklugu-7 (YAB-7) testi Turkce uyarlamasi, gecerlik ve güvenirliği", Archives of Neuropsychiatry, 50(1), 53-59.
- Eser E, Cevik C, Baydur H, Gunes S, Esgin TA, Oztekin CS, Eker E, Gumussoy U, Eser GB, Ozyurt B. Reliability and validity of the Turkish version of the WHO-5, in adults and older adults for its use in primary care settings. Prim Health Care Res Dev. 2019 Jul 1;20:e100. doi: 10.1017/S1463423619000343.
- Dil, S. 2017. "Kadın ruh sağlığı epidemiyolojik göstergeleri ve toplumsal cinsiyet", Turkiye Klinikleri J Psychiatr Nurs-Special Topics, 3(3), 198-203.
- Aypay, A. 2010. "The Adaptation Study of General Self-Efficacy (GSE) Scale to Turkish", Inonu University Journal of the Faculty of Education (INUJFE), 11(2).
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-84391427-050.04-258636
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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