- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03623178
Assertive Community Treatment for Patients Suffering From Substance Use Disorders
May 18, 2025 updated by: Louise Penzenstadler, University Hospital, Geneva
Assertive Community Treatment for Patients Suffering From Substance Use
According to the World Health Organization the population suffering from addiction problems is increasing.
This population is characterized by multiple needs at the medico-psychosocial level.
However, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs.
Persons with substance use disorder often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis.
These individuals also show very low utilization of health care services, accompanied by social marginalization.
This can be related to relapses and poor social functioning.
A high number of relapses occur particularly at the end of hospitalization.
Community Interventions, such as Assertive Community Treatment (ACT) should increase the adherence of these patients to treatment by accompanying them in the community and helping them during sensitive and crisis periods.
One of the objectives of the study is to evaluate the impact of ACT on the time until service disengagement, measuring treatment adherence.
The secondary objectives of this study will be to see the effect of ACT on duration and type of hospitalizations, as well as the number of emergency room visits.
The investigators will focus on the impact of ACT on the participant's medico-psycho-social network, substance use and other psychological variables.
The investigators will also evaluate his or her psychiatric symptoms and global and social functioning.
Life satisfaction and satisfaction with the care received will also be measured.
The study will investigate this through questionnaires at the beginning of care, at three months, six months and 12 months after the start of the ACT intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
29
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Geneva, Switzerland, 1202
- Service d'addictologie, HUG
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subgroup of high need users with difficulties in engaging in substance use disorder treatment.
Description
Inclusion Criteria:
- Substance use disorder
- Competent subjects, able to give informed consent
- French speaking
Exclusion Criteria:
- Evidence of organic brain disease or learning disability based on the chart review.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Assertive Community Treatment
patients with DSM-5 Diagnosis of SUD and one of the following criteria (1) present important functional difficulties, in at least one of the following areas: everyday life activities and maintaining a supportive social network, for minimum two years. or (2) difficulties to attend their health care appointments, during the last 3 months. |
The intervention program is a type of very flexible community treatment.
This is facilitated by a small case load ratio per health care professional (1:10).
The healthcare workers are specialized in SUD treatment.
The time of the intervention differs, there is no prefixed limitation but the duration of the intervention depends on the goals agreed on with the patient.
The main objective of this intervention is to ensure an adherence to an addiction treatment program and establish or consolidate a stable healthcare and social network for the patient.
The intervention aims to prevent service disengagement.
The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment adherence
Time Frame: at 12 months
|
Number of days until service disengagement
|
at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient network
Time Frame: 0, 3, 6, 12 months
|
Number of persons in network
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0, 3, 6, 12 months
|
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Service use
Time Frame: at 12 months
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Number of hospital admissions and number of days in hospital
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at 12 months
|
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Number of ER visits
Time Frame: 0, 3, 6, 12 months
|
Number of ER visits reviewed on patient file
|
0, 3, 6, 12 months
|
|
Addictive behaviour
Time Frame: 0, 3, 6, 12 months
|
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST.
V.3 French)
|
0, 3, 6, 12 months
|
|
General psychiatric symptoms
Time Frame: 0, 3, 6, 12 months
|
Health of Nation Outcome Scale - French version (HoNOS-F): scores 0 - 52 (higher score = more psychiatric symptoms)
|
0, 3, 6, 12 months
|
|
Global Functioning
Time Frame: 0, 3, 6, 12 months
|
World Health Organization Disability Assessment Schedule (WHODAS)
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0, 3, 6, 12 months
|
|
General life satisfaction: Satisfaction With Life Scale
Time Frame: 0, 3, 6, 12 months
|
Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction)
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0, 3, 6, 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction with Assertive Community Treatment
Time Frame: at 3, 6, 12 months
|
Patient satisfaction with Assertive Community Treatment (very satisfied, satisfied, more or less satisfied, not satisfied
|
at 3, 6, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Louise Penzenstadler, MD, University Hospital, Geneva
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
August 1, 2018
First Submitted That Met QC Criteria
August 7, 2018
First Posted (Actual)
August 9, 2018
Study Record Updates
Last Update Posted (Actual)
May 21, 2025
Last Update Submitted That Met QC Criteria
May 18, 2025
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID 2017-01087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.