Stress Management Intervention for Young Turkish Women

Официальное название

A Psychosocial Intervention Program to Improve Stress Management Among Young Women: A Pilot Study

Обзор

This pilot study aims to evaluate the feasibility and probable impact of a low intensity psychosocial intervention program designed to help individuals to manage their stress levels. Consequently, this study will implement and measure the feasibility, randomization, retention, assessment procedures, and preliminary effects of the Self-Help Plus (SH+) program developed by the World Health Organization. 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 young Turkish-speaking women in Türkiye (ages between 18 and 29). Participants who will receive this intervention program will be compared with others in the control group who experience similar stress levels but will not receive SH+ during the trial period. Participants in the control group will receive SH+ after the completion of follow-up assessments at 3 months.

Подробное описание

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).

Вмешательства

• Поведенческое Self-Help Plus
  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 o

Первичные конечные точки

• K10 [Срок оценки: Baseline, within one week after the completion of 5 sessions, and 3 months after the completion of 5 sessions]

Вторичные конечные точки (4)

• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, within one week of completion of 5 sessions, and 3 months after the completion of 5 sessions]
• General Anxiety Disorder-7 (GAD-7) [Срок оценки: 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) [Срок оценки: Baseline, within one week upon completion of 5 sessions, and 3 months after completion of 5 sessions]
• General Self Efficacy Scale (GSES) [Срок оценки: Baseline, within one week upon completion of 5 sessions, and 3 months after 5 sessions]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 20943582
• 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. PMID 3562707
• 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. PMID 24474978
• 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.

Идентификаторы

NCT: NCT07357129 · E-84391427-050.04-258636

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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