Schizophenia DisorderOT-SMINCT07879118
Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
A study testing Occupational Therapy Group Intervention in people with Schizophenia Disorder and Severe Mental Illness, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophenia Disorder, Severe Mental Illness, Bipolar Disorder
- What is being tested?
- Occupational Therapy Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Çekmeköy Toplum Ruh Sağlığı Merkezi
Istanbul, Istanbul, 34782
Şüheda Keleş Özen, BSc, +90 545 554 09 18, suheda.keles@std.medipol.edu.tr
About this study
Official title: The Effect of Occupational Therapy Intervention on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
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.
Read more
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.
- Conditions
- Schizophenia Disorder, Severe Mental Illness, Bipolar Disorder, Nonorganic Psychosis, Schizo-affective Disorder
- Being tested
- Occupational Therapy Group Intervention
- Medical subject headings
- Mental Disorders, Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy Group InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy Intervention Group | Experimental | 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. Receives: Behavioral: Occupational Therapy Group Intervention |
| Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after the 7-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophenia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: an intervention group receiving a seven-session occupational therapy group intervention in addition to routine Community Mental Health Center services, or a control group receiving routine Community Mental Health Center services only. Outcomes will be assessed at baseline and after the seven-week intervention period.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eylül Pınar Kısa, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879118
- Sponsor's protocol ID
- SHD
- Acronym
- OT-SMI
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No