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Stress (Psychology)NCT07357129

Stress Management Intervention for Young Turkish Women

A study testing Self-Help Plus in people with Stress (Psychology), run by Bogazici University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 29 years, women onlyHealthy volunteers can take part
Conditions the study is for
Stress (Psychology)
What is being tested?
Self-Help Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2026to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Boğaziçi University

    Istanbul, Istanbul, 34742

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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).

Being tested
Self-Help Plus
Keywords
Stress management, pilot study, Self-Help Plus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Help PlusBehavioural

    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.

Study groups in NCT07357129
Study groupRoleWhat they receive
Self-Help Plus Intervention GroupExperimentalThis 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.
Receives: Behavioral: Self-Help Plus
Control GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)
  1. Patient Health Questionnaire-9 (PHQ-9)

    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.

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

  2. General Anxiety Disorder-7 (GAD-7)

    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.

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

  3. World Health Organization-Five Well-Being Index (WHO-5)

    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.

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

  4. General Self Efficacy Scale (GSES)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start15 Jan 2026
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357129
Sponsor's protocol ID
E-84391427-050.04-258636
Status last verified
Oct 2026
First submitted
13 Jan 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Consent for such sharing is not part of the informed consent approved by the ethics committee.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

  • 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.

    PubMed 12578436
  • 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.

    PubMed 32800004
  • 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).

  • 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.

    PubMed 35015365

Questions about this trial

What is this clinical trial studying?

A study testing Self-Help Plus in people with Stress (Psychology), run by Bogazici University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

K10 (time frame: Baseline, within one week after the completion of 5 sessions, and 3 months after the completion of 5 sessions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357129, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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