Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial

NCT01936220 | Unknown DMC

• 1 other identifier: Grant 28-1241-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; First-psychotic episode; Initial phase; Relapse prevention; Specialized treatment; Parent groups; Social functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Social functioning

  at year 1, year 3 and year 5

Study Arms (3)

Continuity of specialized care

EXPERIMENTAL

Continuity of specialized inpatient and outpatient care (relapse prevention)

Behavioral: Continuity of specialized care

Continuity of specialized care and parent groups

EXPERIMENTAL

Continuity of specialized care combined with Parent groups

Behavioral: Continuity of specialized care; Behavioral: Parent groups combined with Continuity of Specialized care

Treatment as usual

ACTIVE COMPARATOR

Discontinuity of care, relapse prevention as usual

Behavioral: Discontinuity of care, non specialised care

Interventions

Continuity of specialized care BEHAVIORAL

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).

Also known as: Relapse prevention, Specialized treatment, Maintenance antipsychotic medication

Continuity of specialized care; Continuity of specialized care and parent groups

Parent groups combined with Continuity of Specialized care BEHAVIORAL

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.

Also known as: Family management as developed by Goldstein, Anderson, Falloon, Schooler and collaborators, Adaptation developed for parents of first psychotic episode patients as described in an earlier study of our group.

Continuity of specialized care and parent groups

Discontinuity of care, non specialised care BEHAVIORAL

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.

Also known as: Standard relapse prevention

Treatment as usual

Eligibility Criteria

• Age: 15 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with drug-related psychoses were not included.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Academic Medical Center University of Amsterdam

Amsterdam, North Holland, 1105BC, Netherlands

Location

Related Publications (4)

• Linszen D, Dingemans P, Lenior M. Early intervention and a five year follow up in young adults with a short duration of untreated psychosis: ethical implications. Schizophr Res. 2001 Aug 1;51(1):55-61. doi: 10.1016/s0920-9964(01)00239-0.

  PMID: 11479066 BACKGROUND

• Linszen D, Lenior M, De Haan L, Dingemans P, Gersons B. Early intervention, untreated psychosis and the course of early schizophrenia. Br J Psychiatry Suppl. 1998;172(33):84-9.

  PMID: 9764132 BACKGROUND

• Linszen D, Dingemans P, Van der Does JW, Nugter A, Scholte P, Lenior R, Goldstein MJ. Treatment, expressed emotion and relapse in recent onset schizophrenic disorders. Psychol Med. 1996 Mar;26(2):333-42. doi: 10.1017/s0033291700034723.

  PMID: 8685289 BACKGROUND

• Lenior ME, Dingemans PM, Linszen DH, de Haan L, Schene AH. Social functioning and the course of early-onset schizophrenia: five-year follow-up of a psychosocial intervention. Br J Psychiatry. 2001 Jul;179:53-8. doi: 10.1192/bjp.179.1.53.

  PMID: 11435269 BACKGROUND

Related Links

• The RAISE Early Treatment Program (ETP), led by John Kane, M.D., of the Feinstein Institute for Medical Research in Manhasset, NY, is conducting a similar RCT with the same population and a comparable design.

MeSH Terms

Conditions

Schizophrenia; Social Adjustment

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Don Linszen, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: September 6, 2013
• Study Start: September 1, 1997
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2016
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

NL (1)