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NCT07879118Not yet recruiting

Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness

The Effect of Occupational Therapy Intervention on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
26 Aug 2026
Start date
Oct 2026
Primary completion date
Dec 2026
Lead sponsor
Biruni University
NCT number
NCT07879118

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From Oct 2026 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Being in an acute psychotic exacerbation.
  • Presence of language or speech problems that would prevent participation in the study.

Who the study is looking for

  • 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.
  • Able to read and write.
  • Willing to participate in the study and provide informed consent.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Çekmeköy Toplum Ruh Sağlığı Merkezi
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.