Stress (Psychology)
Conditions
Keywords
Stress management, pilot study, Self-Help Plus
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.
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).
Interventions
BEHAVIORALSelf-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 of listening to pre-recorded audios along with some group discussions moderated by the facilitators.
Sponsors
Bogazici University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| K10 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Self Efficacy Scale (GSES) | 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. |
| Patient Health Questionnaire-9 (PHQ-9) | 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. |
| General Anxiety Disorder-7 (GAD-7) | 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. |
| 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 | 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. |
Contacts
CONTACTYasemin Sohtorik Ilkmen, Psy.D.
Outcome results
None listed