About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Registered at the Community Mental Health Center (CMHC).
Diagnosis of schizophrenia, schizoaffective disorder, non-organic psychosis, or bipolar disorder according to DSM-5 criteria, confirmed by the psychiatrist responsible for the CMHC.
Aged between 18 and 65 years.
In remission, as confirmed by the psychiatrist responsible for the CMHC.
Disqualifiers
Being in an acute psychotic exacerbation.
Presence of a severe neurological disorder or a medical condition that would prevent participation in the intervention.
Presence of cognitive impairment or intellectual disability that would prevent participation in the study.
Presence of language or speech problems that would prevent participation in the study.
Trial design
Parallel
Treatments tested in this trial
Occupational Therapy Group Intervention
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Sponsors and contacts
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