Stress Management Intervention for Young Turkish Women

Bogazici University

Status: Not yet enrolling

Conditions: Stress (Psychology)

Treatments: Behavioral: Self-Help Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT07357129

E-84391427-050.04-258636

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. being a woman
2. being ages between 18 and 29
3. being fluent in Turkish
4. having high levels of psychological distress (scoring above 15 on the Turkish version of the Kessler Psychological Distress Scale (K-10)

Exclusion criteria

1. having an imminent risk of suicide (measured by WHO PM+ assessment tool)
2. having a diagnosis for severe mental disorder (e.g., psychotic disorders or substance dependence)
3. having cognitive impairment (e.g., received a diagnosis of dementia or severe intellectual disability)
4. currently receiving psychological treatment, e.g., therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Self-Help Plus Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Help Plus

Control Group

No Intervention group

Description:

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.