Stress Management Intervention for Young Turkish Women

NCT07357129 | Not Yet Recruiting

• 1 other identifier: E-84391427-050.04-258636
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stress (Psychology)

Keywords

Stress management; pilot study; Self-Help Plus

Outcome Measures

Primary Outcomes (1)

• K10

  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 Outcomes (4)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, within one week of completion of 5 sessions, and 3 months after the completion of 5 sessions

• General Anxiety Disorder-7 (GAD-7)

  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)

  Baseline, within one week upon completion of 5 sessions, and 3 months after completion of 5 sessions

• General Self Efficacy Scale (GSES)

  Baseline, within one week upon completion of 5 sessions, and 3 months after 5 sessions

Study Arms (2)

Self-Help Plus Intervention Group

EXPERIMENTAL

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.

Behavioral: Self-Help Plus

Control Group

NO INTERVENTION

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.

Interventions

Self-Help Plus BEHAVIORAL

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.

Self-Help Plus Intervention Group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Participants who identify as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bogazici University: lead

Related Publications (13)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• Nolen-Hoeksema S. Sex differences in unipolar depression: evidence and theory. Psychol Bull. 1987 Mar;101(2):259-82. No abstract available.

  PMID: 3562707 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12578436 BACKGROUND

• 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.

  PMID: 32800004 BACKGROUND

• Dil, S. 2017. "Kadın ruh sağlığı epidemiyolojik göstergeleri ve toplumsal cinsiyet", Turkiye Klinikleri J Psychiatr Nurs-Special Topics, 3(3), 198-203.

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 35015365 BACKGROUND

Related Links

• WHO: Committing to implementation of the Global Strategy for Women's, Children's and Adolescents' Health (2016-2030)

Central Study Contacts

Yasemin Sohtorik Ilkmen, Psy.D.

CONTACT

90 507 504 5684; sohtorik@bogazici.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A pilot randomized controlled trial (RCT) will be conducted with a total of 60 participants. Participants will be randomly assigned to one of two groups: 30 individuals will receive the Self-Help Plus (SH+) intervention, while the remaining 30 will not take any intervention and serve as the control group. Upon completion of the intervention sessions and three months after completing the intervention, all participants-including those in the control group-will undergo post-intervention assessments, using the same questionnaires administered at baseline. To ensure ethical considerations and promote equity, the SH+ intervention will be given to control group participants right after the follow-up assessment.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share