Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

Summary

The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.

Conditions

• Psychotic Disorders
• Schizophreniform Disorders
• Schizoaffective Disorder
• Psychosis, Brief Reactive
• Schizophrenia, Borderline

Interventions

BEHAVIORAL

Integrated treatment, family involvement

BEHAVIORAL

Social skills training

Sponsors & Collaborators

• Ministry of the Interior and Health, Denmark

  collaborator OTHER_GOV

• Ministry of Social Affairs, Denmark

  collaborator OTHER_GOV

• University of Copenhagen

  collaborator OTHER

• Copenhagen Hospital Corporation

  collaborator OTHER

• Medical Research Council

  collaborator OTHER_GOV

• Wørzners Foundation.

  collaborator UNKNOWN

• Bispebjerg Hospital

  lead OTHER

Principal Investigators

• Merete Nordentoft, Ph.D. · Bispebjerg Hospital, department of psychiatry, University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-01-31

Completion

2022-12-31

Countries

• Denmark

Study Locations