NCT06199817

Brief Summary

Objective: This study aimed to evaluate the effect of multiple occupational therapies on functional remission and subjective recovery of individuals with schizophrenic disorder. Methods: 26 people with schizophrenic disorder were divided into two groups using a random number table. The intervention group participated in routine community mental health center services and a total of 24 sessions of occupational therapies three times a week, while the control group participated in routine community mental health center services.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

February 6, 2024

Status Verified

December 1, 2023

Enrollment Period

5.9 years

First QC Date

December 14, 2023

Last Update Submit

February 2, 2024

Conditions

Keywords

Shizophrenic DisorderOccupational TherapyRemissionWell-Being, Psychological

Outcome Measures

Primary Outcomes (2)

  • Functional Remission of General Schzophrenia Scale (Pre Test)

    The scale is a 5-point Likert type scale consisting of 19 items. The minimum score obtained from the scale is 19 points and the maximum score is 95 points. High scores from the scale indicate high functionality, while low scores from the scale indicate low functionality. Scale scores were expected to be low in the pretest.

    2 month

  • Subjective Recovery Assessment Scale (Pre Test)

    The scale is a 5-point Likert type consisting of 17 items. The lowest score from the scale is 17 and the highest score is 85. Higher scores from the scale indicate that the individual perceives himself as more improved. Scale scores were expected to be low in the pretest.

    2 month

Secondary Outcomes (2)

  • Functional Remission of General Schzophrenia Scale (Post Test)

    Forth month

  • Subjective Recovery Assessment Scale (Post Test)

    Forth month

Other Outcomes (4)

  • Functional Remission of General Schzophrenia Scale (Follow Up Test)

    Seventh month

  • Subjective Recovery Assessment Scale (Follow Up Test)

    Seventh month

  • Effect Size of Functional Remission of General Schzophrenia Scale

    Seventh month

  • +1 more other outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group was informed about the research. The intervention group consists of patients diagnosed with schizophrenic disorder. Music, sports and garden-soil activities were applied to the intervention group.

Behavioral: occupational therapies

Control Group

NO INTERVENTION

The control group was informed about the research.

Interventions

music, garden-soil and sports practices for individuals diagnosed with schizophrenic disorder

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being in the 18-65 age group
  • have been diagnosed with schizophrenia for at least one year
  • be in remission of the disease
  • volunteering to participate in research
  • not have any physical health problems that would prevent their participation in the research

You may not qualify if:

  • have a physical health problem that prevents participation in the research
  • Having a communication problem
  • not willing to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaPsychological Well-Being

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Aysegul Donmez

    Ege University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Phd

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 10, 2024

Study Start

June 1, 2016

Primary Completion

May 1, 2022

Study Completion

August 19, 2022

Last Updated

February 6, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share