Psychotic DisordersNCT00157313
Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
A study testing Integrated treatment, family involvement and Social skills training in people with Psychotic Disorders and Schizophreniform Disorders, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Psychotic Disorders, Schizophreniform Disorders, Schizoaffective Disorder
- What is being tested?
- Integrated treatment, family involvement and Social skills training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 1998to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years of age
- F2 diagnosis in ICD 10
- Address in Copenhagen, Frederiksberg or Aarhus
- Antipsychotic medication not exceeding 12 weeks
- Informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
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.
Read more
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.
Read the 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
- Being tested
- Integrated treatment, family involvement, Social skills training
- Keywords
- Schizophrenia, First episode psychosis, Psychosocial intervention
- Medical subject headings
- Psychotic Disorders, Schizotypal Personality Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated treatment, family involvementBehavioural
Social skills trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic symptoms at one and two year follow-up
Negative symptoms at one and two year follow-up
Secondary outcomes (5)
Adherence at one and two year follow-up
Depression at one and two year follow-up
Suicidal behaviour at one and two year follow-up
Use satisfaction at one and two year follow-up
Quality of life at one and two year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 1998
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark, Ministry of Social Affairs, Denmark, University of Copenhagen, Copenhagen Hospital Corporation, Medical Research Council, Wørzners Foundation.
- Investigators
- Merete Nordentoft, Ph.D., Principal investigator, Bispebjerg Hospital, department of psychiatry, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157313
- Sponsor's protocol ID
- OPUS trial
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 28 Jan 2016
- Results posted
- No
Publications
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.
PubMed 11016522Nordentoft 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.
PubMed 12271808Petersen 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.
PubMed 16141449Thorup 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.
PubMed 16122909Petersen 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.
PubMed 16055817Jeppesen 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.
PubMed 16055815Rosenbaum 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.
PubMed 15863743Starzer M, Hansen HG, Hjorthoj C, Albert N, Lewandowski KE, Glenthoj LB, Nordentoft M. 20-year neurocognitive development following a schizophrenia spectrum disorder and associations with symptom severity and functional outcomes. Psychol Med. 2024 Jul;54(9):2004-2014. doi: 10.1017/S0033291724000096. Epub 2024 Feb 12.
PubMed 38343378Starzer 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.
PubMed 37527479Hansen 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.
PubMed 36811902Madsen 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.
PubMed 26948484Jeppesen 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.
PubMed 18447961
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
- ClinicalTrials.gov ID
- NCT00157313
- Acronym / sponsor ID
- OPUS trial
- Conditions
- Psychotic Disorders, Schizophreniform Disorders, Schizoaffective Disorder, Psychosis, Brief Reactive, Schizophrenia, Borderline
- Keywords
- Schizophrenia, First episode psychosis, Psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark, Ministry of Social Affairs, Denmark, University of Copenhagen, Copenhagen Hospital Corporation, Medical Research Council, Wørzners Foundation.
- Study start
- Jan 1998
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-45 years of age
- F2 diagnosis in ICD 10
- Address in Copenhagen, Frederiksberg or Aarhus
- Antipsychotic medication not exceeding 12 weeks
- Informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated treatment, family involvement | Behavioural | – |
| Social skills training | Behavioural | – |
Primary outcome
Psychotic symptoms at one and two year follow-up
Negative symptoms at one and two year follow-up
5 secondary outcomes
Adherence at one and two year follow-up
Depression at one and two year follow-up
Suicidal behaviour at one and two year follow-up
Use satisfaction at one and two year follow-up
Quality of life at one and two year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Background: PubMed 11016522Jorgensen 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.
- Results publication: PubMed 12271808Nordentoft 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.
- Results publication: PubMed 16141449Petersen 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.
- Results publication: PubMed 16122909Thorup 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.
- Results publication: PubMed 16055817Petersen 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.
- Results publication: PubMed 16055815Jeppesen 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.
- Results publication: PubMed 15863743Rosenbaum 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.
- Derived from this study: PubMed 38343378Starzer M, Hansen HG, Hjorthoj C, Albert N, Lewandowski KE, Glenthoj LB, Nordentoft M. 20-year neurocognitive development following a schizophrenia spectrum disorder and associations with symptom severity and functional outcomes. Psychol Med. 2024 Jul;54(9):2004-2014. doi: 10.1017/S0033291724000096. Epub 2024 Feb 12.
- Derived from this study: PubMed 37527479Starzer 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.
- Derived from this study: PubMed 36811902Hansen 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.
- Derived from this study: PubMed 26948484Madsen 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.
- Derived from this study: PubMed 18447961Jeppesen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nordentoft, Ph.D. principal investigator
Bispebjerg Hospital, department of psychiatry, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated treatment, family involvement and Social skills training in people with Psychotic Disorders and Schizophreniform Disorders, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychotic symptoms at one and two year follow-up. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00157313, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.