Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157313
Status:
UNKNOWN
Last Update Posted:
2016-01-28
First Post:
2005-09-08
Brief Title:
Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 delusionsand 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
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 delusionsand 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 years follow-up psychotic symptoms changed favourably to a mean of 109 standard deviation 127 with an estimated mean difference between groups of -031 95 confidence interval -055 to -007 P002 in favour of integrated treatment Negative symptoms changed favourably with a estimated difference between groups of -036 -054 to -017 P0001 in favour of integrated treatment At two years follow-up the estimated mean difference between groups in psychotic symptoms was -032 -058 to -006 P002 and in negative symptoms was -045 -067 to -022 P0001 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
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 years follow-up psychotic symptoms changed favourably to a mean of 109 standard deviation 127 with an estimated mean difference between groups of -031 95 confidence interval -055 to -007 P002 in favour of integrated treatment Negative symptoms changed favourably with a estimated difference between groups of -036 -054 to -017 P0001 in favour of integrated treatment At two years follow-up the estimated mean difference between groups in psychotic symptoms was -032 -058 to -006 P002 and in negative symptoms was -045 -067 to -022 P0001 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None