An interventional study of Occupational Therapy Group Intervention in Schizophenia Disorder, Severe Mental Illness and Bipolar Disorder, sponsored by Biruni University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with significant impairments in psychosocial functioning, daily life participation, self-efficacy, and social functioning. Despite pharmacological treatment, many individuals continue to experience limitations in social relationships, occupational roles, independent living activities, and overall functioning. Psychosocial rehabilitation interventions are therefore important components of comprehensive mental health care.
Occupational therapy aims to improve individuals' participation in meaningful daily activities, enhance occupational performance, strengthen social roles, and support recovery. However, evidence regarding the effects of occupational therapy interventions on internalized stigma, self-efficacy, and personal and social functioning among individuals with SMI remains limited.
This randomized controlled trial aims to investigate the effects of a structured occupational therapy group intervention on internalized stigma, self-efficacy, personal and social functioning, occupational performance, and instrumental activities of daily living in individuals with SMI receiving services at a Community Mental Health Center. Eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a seven-session occupational therapy group program, with one 60-90-minute session per week, while the control group will continue to receive routine Community Mental Health Center services.
The intervention addresses self-awareness and identity, internalized stigma, personal strengths and self-efficacy, daily life roles, role performance, goal setting, and social participation through structured group activities and psychoeducational components. Outcomes will be assessed before the intervention and after the seven-week intervention period using validated measures of internalized stigma, self-efficacy, personal and social functioning, occupational performance and satisfaction, and instrumental activities of daily living.
It is hypothesized that participants receiving the occupational therapy intervention will demonstrate reduced internalized stigma and improved self-efficacy and personal and social functioning compared with participants receiving routine services alone.
2,148 studies on the registry are indexed under Mental Disorders; 425 are open to participants now.
This study's planned enrollment of 50 is below the median of 96 across 1,607 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Biruni University is the lead sponsor of 179 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive a structured seven-session occupational therapy group intervention in addition to routine Community Mental Health Center services. Sessions will be delivered once weekly for 60-90 minutes over seven weeks.
Behavioral: Occupational Therapy Group Intervention
Participants in this group will continue to receive routine Community Mental Health Center services and will not receive any additional occupational therapy intervention during the seven-week study period.
A structured occupational therapy group intervention consisting of seven weekly sessions, each lasting approximately 60-90 minutes. The program addresses self-awareness and identity, internalized stigma, personal strengths and self-efficacy, daily life roles, role performance, goal setting, and social participation through structured group activities and psychoeducational components.
Change in Internalized Stigma of Mental Illness Scale (ISMI) Score
Internalized stigma will be assessed using the Internalized Stigma of Mental Illness Scale (ISMI). The scale consists of 29 items rated on a 4-point Likert scale. Total scores range from 29 to 116, with higher scores indicating higher levels of internalized stigma.
Time frame: Baseline and immediately after the 7-week intervention.
Change in General Self-Efficacy Scale Score
Self-efficacy will be assessed using the 17-item General Self-Efficacy Scale. Total scores range from 17 to 85, with higher scores indicating greater self-efficacy.
Time frame: Baseline and immediately after the 7-week intervention.
Change in Personal and Social Performance Scale (PSP) Score
Personal and social functioning will be assessed using the Personal and Social Performance Scale. The overall score ranges from 1 to 100, with higher scores indicating better personal and social functioning.
Time frame: Baseline and immediately after the 7-week intervention.
Change in Canadian Occupational Performance Measure (COPM) Scores
Occupational performance will be assessed using the Canadian Occupational Performance Measure (COPM). Participants identify and prioritize occupational performance problems and rate their perceived performance on a 10-point scale, with higher scores indicating better perceived occupational performance. Change in occupational performance from baseline to post-intervention will be evaluated.
Time frame: Baseline and immediately after the 7-week intervention.
Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) Score
Independence in instrumental activities of daily living will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Scale. Total scores range from 0 to 8, with higher scores indicating greater independence.
Time frame: Baseline and immediately after the 7-week intervention.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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