Schizophenia DisorderNCT06883734
The Effect of Illness Management Skill Training Applied to Patients With Schizophrenia
A study testing Illness Management Skills Training in people with Schizophenia Disorder, run by Neslihan Lok at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophenia Disorder
- What is being tested?
- Illness Management Skills Training
- 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
- 15 Aug 2024to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Medical Hospital
Konya, 42230
About this study
Official title: 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.
Read more
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.
Read the detailed description
The study examined 110 individuals aged 18-65 who were diagnosed with schizophrenia and applied to the S.U. Faculty of Medicine Mental Health and Diseases Polyclinic in the last year, according to the inclusion-exclusion criteria. A total of 50 individuals diagnosed schizophrenia were included in the study. These individuals were randomly assigned to two groups: intervention and control. Pre-test data were collected using the "Personal Information Form", "Modified Engulfment Scale", "SF 36 Quality of Life Scale" and "Illness Management and Recovery Scale-Patient Form" from the intervention and control groups by researchers between August 2024 and February 2025 in the Group Therapy Room of the Mental Health and Diseases Polyclinic, based on self-reporting. The "Illness Management Skills Training" was applied to the intervention group in 4 groups, one session per week, for a total of 12 weeks. At the end of the Illness Management Skills Training, both the intervention and control groups were administered the "Modified Engulfment Scale", "SF 36 Quality of Life Scale" and "Illness Management and Recovery Scale-Patient Form". No intervention was applied to the control group throughout the 12-week program; the patients continued with their routine outpatient clinic check-ups.
- Conditions
- Schizophenia Disorder
- Being tested
- Illness Management Skills Training
- Keywords
- Schizophrenia, engulfment, quality of life, illness management, recovery, Illness Management Skills Training, psychiatric nursing
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Illness Management Skills TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group was a group of 25 people consisting of patients with schizophrenia who followed the 12-week Illness Management Skills Training. Receives: Behavioral: Illness Management Skills Training |
| Control | No intervention | The control group consisted of 25 patients with schizophrenia who attended routine outpatient clinic check-ups for 12 weeks without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness management and recovery total mean score
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.
Measured: From enrollment to the end of training at 12 weeks
Secondary outcomes (2)
Engulfment total mean score
The score range of the Modified Engulfment Scale is 25-125. Increasing scores from the scale indicate increased engulfment .
Measured: 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
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.
Measured: From enrollment to the end of training at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Aug 2024
- Primary completion31 Jan 2025
- Study completion17 Feb 2025
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
- This study was a randomized controlled trial with pre-test and post-test control groups.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neslihan Lok
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Sponsor-investigator, Neslihan Lok, Selcuk University
- Investigators
- Neslihan Lok, Prof. Dr, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883734
- Sponsor's protocol ID
- SelcukU-GUzun-002
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Illness Management Skill Training Applied to Patients With Schizophrenia on Engulfment, Quality of Life and Illness Management and Recovery Levels
- ClinicalTrials.gov ID
- NCT06883734
- Acronym / sponsor ID
- SelcukU-GUzun-002
- Conditions
- Schizophenia Disorder
- Keywords
- Schizophrenia, engulfment, quality of life, illness management, recovery, Illness Management Skills Training, psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Neslihan LokUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study examined 110 individuals aged 18-65 who were diagnosed with schizophrenia and applied to the S.U. Faculty of Medicine Mental Health and Diseases Polyclinic in the last year, according to the inclusion-exclusion criteria. A total of 50 individuals diagnosed schizophrenia were included in the study. These individuals were randomly assigned to two groups: intervention and control. Pre-test data were collected using the "Personal Information Form", "Modified Engulfment Scale", "SF 36 Quality of Life Scale" and "Illness Management and Recovery Scale-Patient Form" from the intervention and control groups by researchers between August 2024 and February 2025 in the Group Therapy Room of the Mental Health and Diseases Polyclinic, based on self-reporting. The "Illness Management Skills Training" was applied to the intervention group in 4 groups, one session per week, for a total of 12 weeks. At the end of the Illness Management Skills Training, both the intervention and control groups were administered the "Modified Engulfment Scale", "SF 36 Quality of Life Scale" and "Illness Management and Recovery Scale-Patient Form". No intervention was applied to the control group throughout the 12-week program; the patients continued with their routine outpatient clinic check-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a randomized controlled trial with pre-test and post-test control groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Illness Management Skills TrainingThe intervention group was a group of 25 people consisting of patients with schizophrenia who followed the 12-week Illness Management Skills Training. |
| Control | No intervention | –The control group consisted of 25 patients with schizophrenia who attended routine outpatient clinic check-ups for 12 weeks without any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Illness Management Skills TrainingIn 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. | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
Engulfment total mean score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Schizophenia Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neslihan Lok, Prof. Dr study director
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Illness Management Skills Training in people with Schizophenia Disorder, run by Neslihan Lok at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness management and recovery total mean score (time frame: From enrollment to the end of training at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.