NCT03623178

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 21, 2025

Status Verified

August 1, 2018

Enrollment Period

5.1 years

First QC Date

August 1, 2018

Last Update Submit

May 18, 2025

Conditions

Keywords

Substance Use DisordersAssertive Community TreatmentCommunity TreatmentTreatment engagementService Use

Outcome Measures

Primary Outcomes (1)

  • Treatment adherence

    Number of days until service disengagement

    at 12 months

Secondary Outcomes (7)

  • Service use

    at 12 months

  • Patient network

    0, 3, 6, 12 months

  • Number of ER visits

    0, 3, 6, 12 months

  • Addictive behaviour

    0, 3, 6, 12 months

  • General psychiatric symptoms

    0, 3, 6, 12 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Patient satisfaction with Assertive Community Treatment

    at 3, 6, 12 months

Study Arms (1)

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.

Other: Assertive Community Treatment

Interventions

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.

Assertive Community Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subgroup of high need users with difficulties in engaging in substance use disorder treatment.

You may qualify if:

  • Substance use disorder
  • Competent subjects, able to give informed consent
  • French speaking

You may not qualify if:

  • Evidence of organic brain disease or learning disability based on the chart review.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'addictologie, HUG

Geneva, 1202, Switzerland

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Community Mental Health Services

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Louise Penzenstadler, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 9, 2018

Study Start

December 1, 2017

Primary Completion

January 1, 2023

Study Completion

December 1, 2023

Last Updated

May 21, 2025

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations