ISRCTN - ISRCTN37364372: A trial comparing the effectiveness of Assertive Community Treatment enhanced with evidence based interventions with standard Assertive Community Treatment

Plain English Summary

Background and study aims
For the severely mentally ill, Assertive Community Treatment (ACT), an intensive approach to mental health care delivery, has been shown to be better than other types of care delivery in keeping in contact with the patients, who are often very reluctant to have care, and are difficult to engage. In previous trials, other outcomes also appeared to improve. However, more recent trials including one carried out by our group, did not show important positive changes to number of inpatient days, symptoms, or social functioning. Therefore, we think that the treatment content of standard ACT is not enough to accomplish more important improvements. We thought that carrying out evidence based interventions, such as psycho-education, family interventions, cognitive behavioural therapy, and individual placement and support, in addition to standard ACT, and carried out by dedicated therapists from outside the ACT team might improve how well ACT works in reducing admission days and improving social functioning and symptom severity. The objectives of the study were to see how well it works.

Who can participate?
Severely mentally ill patients who were going to receive care by one of the two new ACT teams working in the same catchment area in the city of Leeuwarden, were selected by their Health of the Nations Outcomes Scale (HoNOS) scores. The scores had to be at least 14 to be included in the study: if this was the case they were scored again, and if the score was still at least 14, the patients were randomly allocated to one of the two ACT teams.

What does the study involve?
One of the teams was randomly selected to have their patients receive the evidence-based interventions from external dedicated therapists. Patients in that team were screened for eligibility and asked to participate in each one of the four mentioned interventions. If they were willing to participate, the intervention was carried out, as long as the patient agreed or until the goals were accomplished. This procedure gave us information on the feasibility of these interventions in a difficult to engage group of patients. The given treatment thus depends on the willingness of the patient and having the opportunity to engage in the offered treatments. We then compared the effects of the enhanced ACT with standard ACT to see whether the interventions had any effect on the number of inpatient days or functional and symptomatic outcomes.

What are the possible benefits and risks of participating?
The delivered therapies might have improved functioning, severity of symptoms, and most importantly the ability to stay out of the psychiatric hospital. There were no known risks.

Where is the study run from?
The study was conducted with the two ACT teams of Friesland Mental Health Services in
Leeuwarden (Netherlands).

When is the study starting and how long is it expected to run for?
The study started in 2008, and patients were recruited between July 2008 and July 2009; the final assessments were completed in 2011 and data collection was completed by July 2012.

Who is funding the study?
Netherlands Organisation for Health Research and Development (ZonMw) and Friesland Mental Health Services (Netherlands).

Who is the main contact?
Dr S. Sytema, Senior Researcher at University Medical Center Groningen
s.sytema@umcg.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lex Wunderink

ORCID ID

Contact details

Sixmastraat 2
Leeuwarden
8932 PA
Netherlands
+31 (0)64 612 11 36
lex.wunderink@ggzfriesland.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

60-60110-98-162

Study information

Scientific title

The effectiveness of Assertive Community Treatment (ACT) enhanced with evidence based interventions vs. standard ACT: an open randomized controlled trial

Acronym

ACT+

Study hypothesis

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.

Ethics approval

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.

Study design

Open randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Admission days

Secondary outcome measures

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.

Overall trial start date

01/07/2008

Overall trial end date

01/07/2012

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Age less than18 years

Recruitment start date

01/07/2008

Recruitment end date

01/07/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Sixmastraat 2
Leeuwarden
8932 PA
Netherlands

Sponsor information

Organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
PO Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 52 43
vesters@zonmw.nl

Sponsor type

Research organisation

Website

http://zonmw.nl

Funders

Funder type