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

NCT ID: NCT00157313

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-01-31
• Study Completion Date: 2022-12-31

Brief 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.

Detailed Description

Objectives: To evaluate the effects of integrated treatment for patients with a first episode of psychotic illness.

Design: Randomised clinical trial. Setting: Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark Participants: 547 patients with first episode of schizophrenia spectrum disorder.

Interventions: Integrated treatment and 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.

Main outcome measures: Psychotic and negative symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.

Results: At one year's follow-up, psychotic symptoms changed favourably to a mean of 1.09 (standard deviation 1.27) with an estimated mean difference between groups of -0.31 (95% confidence interval -0.55 to -0.07, P=0.02) in favour of integrated treatment. Negative symptoms changed favourably with a estimated difference between groups of -0.36 (-0.54 to -0.17, P<0.001) in favour of integrated treatment. At two years' follow-up the estimated mean difference between groups in psychotic symptoms was -0.32 (-0.58 to -0.06, P=0.02) and in negative symptoms was -0.45 (-0.67 to -0.22, P<0.001), both in favour of integrated treatment. Patients who received integrated treatment had significantly less comorbid substance misuse, better adherence to treatment, and more satisfaction with treatment.

Conclusion: Integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Integrated treatment, family involvement

Intervention Type: BEHAVIORAL

Social skills training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-45 years of age
• F2 diagnosis in ICD 10
• Address in Copenhagen, Frederiksberg or Aarhus
• Antipsychotic medication not exceeding 12 weeks
• Informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of the Interior and Health, Denmark

OTHER_GOV

Sponsor Role: collaborator

Ministry of Social Affairs, Denmark

OTHER_GOV

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Copenhagen Hospital Corporation

OTHER

Sponsor Role: collaborator

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

Wørzners Foundation.

UNKNOWN

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Merete Nordentoft, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital, department of psychiatry, University of Copenhagen

Locations

Bispebjerg Hospital, department of psychiatry

Copenhagen, , Denmark

Countries

Denmark

References

Jorgensen P, Nordentoft M, Abel MB, Gouliaev G, Jeppesen P, Kassow P. Early detection and assertive community treatment of young psychotics: the Opus Study Rationale and design of the trial. Soc Psychiatry Psychiatr Epidemiol. 2000 Jul;35(7):283-7. doi: 10.1007/s001270050240.

Reference Type: BACKGROUND

PMID: 11016522 (View on PubMed)

Nordentoft M, Jeppesen P, Abel M, Kassow P, Petersen L, Thorup A, Krarup G, Hemmingsen R, Jorgensen P. OPUS study: suicidal behaviour, suicidal ideation and hopelessness among patients with first-episode psychosis. One-year follow-up of a randomised controlled trial. Br J Psychiatry Suppl. 2002 Sep;43:s98-106. doi: 10.1192/bjp.181.43.s98.

Reference Type: RESULT

PMID: 12271808 (View on PubMed)

Petersen L, Jeppesen P, Thorup A, Abel MB, Ohlenschlaeger J, Christensen TO, Krarup G, Jorgensen P, Nordentoft M. A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ. 2005 Sep 17;331(7517):602. doi: 10.1136/bmj.38565.415000.E01. Epub 2005 Sep 2.

Reference Type: RESULT

PMID: 16141449 (View on PubMed)

Thorup A, Petersen L, Jeppesen P, Ohlenschlaeger J, Christensen T, Krarup G, Jorgensen P, Nordentoft M. Integrated treatment ameliorates negative symptoms in first episode psychosis--results from the Danish OPUS trial. Schizophr Res. 2005 Nov 1;79(1):95-105. doi: 10.1016/j.schres.2004.12.020.

Reference Type: RESULT

PMID: 16122909 (View on PubMed)

Petersen L, Nordentoft M, Jeppesen P, Ohlenschaeger J, Thorup A, Christensen TO, Krarup G, Dahlstrom J, Haastrup B, Jorgensen P. Improving 1-year outcome in first-episode psychosis: OPUS trial. Br J Psychiatry Suppl. 2005 Aug;48:s98-103. doi: 10.1192/bjp.187.48.s98.

Reference Type: RESULT

PMID: 16055817 (View on PubMed)

Jeppesen P, Petersen L, Thorup A, Abel MB, Oehlenschlaeger J, Christensen TO, Krarup G, Hemmingsen R, Jorgensen P, Nordentoft M. Integrated treatment of first-episode psychosis: effect of treatment on family burden: OPUS trial. Br J Psychiatry Suppl. 2005 Aug;48:s85-90. doi: 10.1192/bjp.187.48.s85.

Reference Type: RESULT

PMID: 16055815 (View on PubMed)

Rosenbaum B, Valbak K, Harder S, Knudsen P, Koster A, Lajer M, Lindhardt A, Winther G, Petersen L, Jorgensen P, Nordentoft M, Andreasen AH. The Danish National Schizophrenia Project: prospective, comparative longitudinal treatment study of first-episode psychosis. Br J Psychiatry. 2005 May;186:394-9. doi: 10.1192/bjp.186.5.394.

Reference Type: RESULT

PMID: 15863743 (View on PubMed)

Starzer MSK, Hansen HG, Hjorthoj C, Speyer H, Albert N, Nordentoft M. Predictors of Mortality Following a Schizophrenia Spectrum Diagnosis: Evidence From the 20-Year Follow-up of the OPUS Randomized Controlled Trial. Schizophr Bull. 2023 Sep 7;49(5):1256-1268. doi: 10.1093/schbul/sbad111.

Reference Type: DERIVED

PMID: 37527479 (View on PubMed)

Hansen HG, Starzer M, Nilsson SF, Hjorthoj C, Albert N, Nordentoft M. Clinical Recovery and Long-Term Association of Specialized Early Intervention Services vs Treatment as Usual Among Individuals With First-Episode Schizophrenia Spectrum Disorder: 20-Year Follow-up of the OPUS Trial. JAMA Psychiatry. 2023 Apr 1;80(4):371-379. doi: 10.1001/jamapsychiatry.2022.5164.

Reference Type: DERIVED

PMID: 36811902 (View on PubMed)

Madsen T, Karstoft KI, Secher RG, Austin SF, Nordentoft M. Trajectories of suicidal ideation in patients with first-episode psychosis: secondary analysis of data from the OPUS trial. Lancet Psychiatry. 2016 May;3(5):443-50. doi: 10.1016/S2215-0366(15)00518-0. Epub 2016 Mar 3.

Reference Type: DERIVED

PMID: 26948484 (View on PubMed)

Jeppesen P, Petersen L, Thorup A, Abel MB, Ohlenschlaeger J, Christensen TO, Krarup G, Jorgensen P, Nordentoft M. The association between pre-morbid adjustment, duration of untreated psychosis and outcome in first-episode psychosis. Psychol Med. 2008 Aug;38(8):1157-66. doi: 10.1017/S0033291708003449. Epub 2008 Apr 30.

Reference Type: DERIVED

PMID: 18447961 (View on PubMed)

Other Identifiers

OPUS trial

Identifier Type: -

Identifier Source: org_study_id