NCT06883734

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

August 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 13, 2025

Last Update Submit

March 18, 2025

Conditions

Keywords

Schizophreniaengulfmentquality of lifeillness managementrecoveryIllness Management Skills Trainingpsychiatric nursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of training at 12 weeks

Secondary Outcomes (2)

  • Engulfment total mean score

    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

    From enrollment to the end of training at 12 weeks

Study Arms (2)

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.

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.

Interventions

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.

Intervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University Faculty of Medical Hospital

Konya, 42230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Neslihan Lok, Prof. Dr

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was a randomized controlled trial with pre-test and post-test control groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr, Study Director

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

August 15, 2024

Primary Completion

January 31, 2025

Study Completion

February 17, 2025

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations