Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial

Study Overview
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Brief Summary
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Objective: to evaluate the effectiveness of specialised and sustained intervention with or without parent groups during the initial phase of schizophrenia or related disorders on relapse prevention Methods: A three conditions randomized trial with a duration of five years Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic episode of schizophrenia or related disorder Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent groups (ST+P) and Treatment As Usual (TAU). Outcome-measures: cumulative relapse rates and time to first relapse after first remission. Secondary outcome measure: social functioning. Statistical analysis: cumulative relapse rates using life-table methods. The effect of the three interventions on time to first relapse after remission will be compared using Cox regression analysing intention to treat (ITT) grouping.

Detailed Description
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Evidence for optimal duration and necessary ingredients of early and sustained specialized treatment from first episode psychosis till the end of the initial phase schizophrenia is still insufficient. Randomized trials with a treatment duration of six months to two years with favorable symptomatic and psychosocial results disappeared at five year follow-up. Other studies suggest that specialized treatment should last 5 years in order to be able to prevent instead of only delaying clinical and psychosocial deteriorating. In this study we examine both the symptomatic (relapse) and psychosocial outcome of a three armed five year randomized trial in the initial phase of schizophrenia.

Official Title
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Relapse Prevention in First Episode of Schizophrenia and Related Psychotic Disorders: a 5 Year Randomized Controlled Trial

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Continuity of specialized care
* Behavioral: Parent groups combined with Continuity of Specialized care
* Behavioral: Discontinuity of care, non specialised care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were eligible for the study if they: 1) met DSM-IV-Revised criteria for schizophrenia or related disorders, 2) were suffering from a first psychotic episode and 3) were living in contact with parent(s) or other relatives. Exclusion Criteria: Patients with drug-related psychoses were not included.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuity of specialized care<br>Continuity of specialized inpatient and outpatient care (relapse prevention) | Behavioral: Continuity of specialized care<br>* Continuity of care in treatment and professional caregiver was given during 5 year. Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).<br>* Other names: Maintenance antipsychotic medication;|
| Experimental: Continuity of specialized care and parent groups<br>Continuity of specialized care combined with Parent groups | Behavioral: Continuity of specialized care<br>* Continuity of care in treatment and professional caregiver was given during 5 year. Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).<br>* Other names: Maintenance antipsychotic medication;Behavioral: Parent groups combined with Continuity of Specialized care<br>* Approximately fifty parent group therapy sessions will be held in a flexible way over a 60 month period. Each parent group was run by two experienced family therapists.<br>* Other names: Adaptation developed for parents of first psychotic episode patients as described in an earlier study of our group.;|
| Active Comparator: Treatment as usual<br>Discontinuity of care, relapse prevention as usual | Behavioral: Discontinuity of care, non specialised care<br>* Standard Treatment as usual (TU) was provided during 5 years by local mental health care professionals situated nearby the domicile of patients. TU had comparable treatment targets as ST but was not provided by treatment staff specialized in early intervention in schizophrenia or related disorders. However, TU was (like ST) sustained and dedicated to prevent psychotic relapse and improve social functioning.<br>* Other names: Standard relapse prevention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Psychotic relapse | Participants will be followed for the duration of the 5 year outpatient treatment of the trial. During the trial the timing and number of psychotic relapses of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial. Trained interviewers not involved in clinical treatment of patients will elicit with the LCS detailed information of symptoms, signs and treatment from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in symptomatology since the last interview. All details will be fitted in a schedule with 6 months intervals. | at year 1, year 3 and year 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Social functioning | During the duration of the 5 year outpatient treatment of the trial social functioning of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial. Detailed information of social functioning in work, study, school and relations will be elicited from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in functioning since the last interview.All details will be fitted in a schedule with 6 months. | at year 1, year 3 and year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, First-psychotic episode, Initial phase, Relapse prevention, Specialized treatment, Parent groups, Social functioning