Stress Management Intervention for Young Turkish Women
ConditionStress (Psychology)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-29
SponsorBogazici University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Self-Help Plus
BehavioralSelf-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Self-Help Plus Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline, within one week after the completion of 5 sessions, and 3 months after the completion of 5 sessionsSecondary outcomes
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.
Time frame
Baseline, within one week of completion of 5 sessions, and 3 months after the completion of 5 sessions2
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.
Time frame
Baseline, within one week upon completion of 5 sessions, and 3 months after completion of 5 sessions3
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.
Time frame
Baseline, within one week upon completion of 5 sessions, and 3 months after completion of 5 sessions4
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.
Time frame
Baseline, within one week upon completion of 5 sessions, and 3 months after 5 sessionsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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