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ISRCTN
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ISRCTN37364372
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DOI
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10.1186/ISRCTN37364372
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A trial comparing the effectiveness of Assertive Community Treatment enhanced with evidence based interventions with standard Assertive Community Treatment
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Scientific title
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The effectiveness of Assertive Community Treatment (ACT) enhanced with evidence based interventions vs. standard ACT: an open randomized controlled trial
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Acronym
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ACT+
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Serial number at source
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60-60110-98-162
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Study hypothesis
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Enhanced ACT, including evidence based interventions carried out by non-team professionals, will be superior to standard ACT in terms of reducing admission days (primary outcome), and improving social functioning and symptomatic outcomes.
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Lay summary
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Lay summary under review 1
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Ethics approval
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The Medical Ethical Committee of the University Medical Center Groningen did not judge the trial to need ethical approval (patients were treated conforming to usual care standards and evidence based practice, in both the experimental and control conditions, and data were gathered by routine outcome monitoring. The randomization to one of two study arms did not influence regular care.
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Study design
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Open randomized controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Severely mentally ill patients with multiple diagnoses: schizophrenia, other non-affective psychoses, affective psychoses, other persistent and severe mental illness, often with comorbid substance abuse, always having led to functional deficits
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Participants - inclusion criteria
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1. Adult (male and female) severely mentally ill patients living in the city of Leeuwarden, the Netherlands
2. With an indication for ACT
3. Repeated Health of the Nation Outcome Score (HoNOS) total score of at least 14 before inclusion
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Participants - exclusion criteria
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Age less than18 years
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Anticipated start date
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01/07/2008
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Anticipated end date
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01/07/2012
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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150
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Interventions
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The experimental arm was assertive community treatment with additional evidence based interventions (psycho-education, family interventions, cognitive behavioral therapy and individual placement and support carried out by non-team members). These interventions were proposed to the eligible patients and carried out conforming to the guidelines as long as the patients would be willing to participate or until the goals were accomplished. Patients who did not participate would not drop out of the study (intention to treat).
The control arm was Assertive Community Treatment according to the standards (DACTS fidelity scale) without evidence based interventions carried out by non-team therapists. The mean (sd) number of sessions in successful interventions were: 24.3 (14.0) in family interventions, 4.5 (2.4) in psycho-education, 7.0 (4.2) in individual placement and support and 8.3 (1.5) in cognitive behavioral therapy. The feasibility of the interventions was one of the results of this study and will be described in a paper.
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Primary outcome measure(s)
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Admission days
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Secondary outcome measure(s)
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1. Symptom severity, measured by the Positive and Negative Syndrome Scale (PANSS) and the Montgomery Asberg Depression Rating Scale (MADRS)
2. Social functioning (Social Functioning Assessment Scale [SOFAS])
3. Needs for care (Camberwell Assessment of Needs Short Assessment Scale [CANSAS])
4. Quality of life (Manchester Short Assessment Scale [MANSA]); the PANSS, MADRS and SOFAS were rated by routIne outcome monitoring nurses during the interview sessions, the CANSAS and MANSA were self-rated by the participants. There were two assessments, the first one closely after inclusion in the trial and the second one two years later.
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Sources of funding
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Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) ref: 60-60110-98-162
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Trial website
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Publications
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Contact name
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Dr
Lex
Wunderink
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Address
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Sixmastraat 2
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City/town
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Leeuwarden
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Zip/Postcode
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8932 PA
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Country
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Netherlands
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Tel
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+31 (0)64 612 11 36
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Email
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lex.wunderink@ggzfriesland.nl
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Sponsor
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Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
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Address
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Laan van Nieuw Oost Indië 334
PO Box 93245
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City/town
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Den Haag
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Zip/Postcode
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2509 AE
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Country
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Netherlands
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Tel
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+31 (0)70 349 52 43
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Fax
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+31 (0)70 349 53 93
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Email
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vesters@zonmw.nl
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Sponsor website:
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http://zonmw.nl
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Date applied
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03/03/2013
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Last edited
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15/03/2013
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Date ISRCTN assigned
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15/03/2013
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