- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06883734
The Effect of Illness Management Skill Training Applied to Patients with Schizophrenia
The Effect of Illness Management Skill Training Applied to Patients with Schizophrenia on Engulfment, Quality of Life and Illness Management and Recovery Levels
This study was aimed to examine the effectiveness (illness management and recovery, engulfment, quality of life) of a 12-week the Illness Management Skills Training applied to patients with schizophrenia. The main questions it aims to answer are:
Hypothesis (H1-1): Illness Management Skills Training applied intervention group has lower engulfment than the control group.
Hypothesis (H1-2): Illness Management Skills Training applied intervention group has higher quality of life than the control group.
Hypothesis (H1-3): Illness Management Skills Training applied intervention group has higher illness management and recovery level than the control group.
Researchers were compared the Illness Management Skills Training to a control group (no intervention) to see if the Illness Management Skills Training works on engulfment, quality of life, illness management and recovery in patients with schizophrenia.
Participants were:
- attended the Illness Management Skills Training, one session per week for 12 weeks, 60 minutes per session, in addition to routine outpatient clinic check-ups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey, 42230
- Selcuk University Faculty of Medical Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between the ages of 18-65,
- Having been diagnosed with Schizophrenia for at least 6 months according to ICD-10,
- Being registered with the Selcuk University Faculty of Medical Hospital Mental Health and Diseases Polyclinic,
- Coming to the polyclinic for regular check-ups,
- Getting a mild/moderate score from the Positive and Negative Syndrome Scale (PANSS),
- Taking medication regularly,
- Being at least literate.
Exclusion Criteria:
- Having an organic mental disorder or mental retardation,
- Having a visual or hearing impairment,
- Participating in a program similar to the intervention to be implemented.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
The intervention group was a group of 25 people consisting of patients with schizophrenia who followed the 12-week Illness Management Skills Training.
|
In this study, in addition to routine outpatient clinic check-ups, 12 sessions of Illness Management Skills Training were applied to the intervention group of 25 patients, each in four separate groups of 6+6+6+7 patients (Group 1, Group 2, Group 3, Group 4), once a week, for 60 minutes each.
The training consisted of 1) Introduction-Getting Acquainted, 2) Recovery Goals, 3) Understanding Schizophrenia-1, 4) Understanding Schizophrenia-2, 5) Stress Vulnerability Model and Coping with Stress-1, 6) Stress Vulnerability Model and Coping with Stress-2, 7) Learning About Medication, 8) Using Medication Effectively and Monitoring Treatment, 9) Coping with Persistent Symptoms, 10) Recognizing and Monitoring Warning Signs, 11) Warning Signs My Emergency Plan, and 12) Termination sessions.
|
|
No Intervention: Control
The control group consisted of 25 patients with schizophrenia who attended routine outpatient clinic check-ups for 12 weeks without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Illness management and recovery total mean score
Time Frame: From enrollment to the end of training at 12 weeks
|
The Illness Management and Recovery Scale-Patient Form total score from the scale is 15-75.
Increasing scores from the scale indicate that illness management and recovery also increase.
|
From enrollment to the end of training at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Engulfment total mean score
Time Frame: From enrollment to the end of training at 12 weeks
|
The score range of the Modified Engulfment Scale is 25-125.
Increasing scores from the scale indicate increased engulfment .
|
From enrollment to the end of training at 12 weeks
|
|
Physical function, social function, physical role difficulty, emotional role difficulty, mental health, energy/vitality, pain and general health Physical and Mental Component Summary Scale mean scores
Time Frame: From enrollment to the end of training at 12 weeks
|
The SF 36 Quality of Life scale evaluates quality of life through the sub-dimensions of physical function, social function, physical role difficulty, emotional role difficulty, mental health, energy/vitality, pain and general health.
The scale has a physical and mental health summary scale.
0-100 points can be obtained from each sub-dimension.
A score of "0" indicates poor health, while a score of 100 indicates good health, and as scores increase, the quality of life also increases.
|
From enrollment to the end of training at 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Neslihan Lok, Prof. Dr, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SelcukU-GUzun-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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