Condition category
Mental and Behavioural Disorders
Date applied
25/08/2009
Date assigned
11/09/2009
Last edited
05/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Veerle Raes

ORCID ID

Contact details

De Sleutel
Department of Research and Quality Assurance
Jozef Guislainstraat 43a
Gent
B-9000
Belgium
veerle.raes@fracarita.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A multicentre randomised controlled trial on the effectiveness of using instruments in outpatient individual substance abuse treatment to enhance treatment compliance

Acronym

Study hypothesis

The main focus of this study is to prove evidence in favour of the use of instruments by clinical workers as an integrated part of a treatment plan, in order to enhance the number of individual sessions - i.e. treatment adherence/retention/compliance - in outpatient substance abuse treatment centres.

Ethics approval

Central Ethics Board for the Mental Health Sector of the n.p.o. Provincialat of the Brothers of Charity, Bierbeek, approved on the 13th November 2006 (ref: OG054-2006-19)

Study design

Multicentre randomised controlled trial (Zelen’s design)

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

Substance abuse

Intervention

The treatment consists of individual counselling sessions, starting from the information from the EuropASI-interview. In the experimental group, the treatment plan includes five standardised sessions or session parts:
1. Explaining to the patient about the specific interventions to expect, in order to get informed consent
2. Introduction of the Readiness for Change Questionnaire with completion by the patient
3. Giving feedback on RCQ, using the stages of change motivation circle and associated work-sheets
4. The PREDI-interview
5. Giving feedback on PREDI, using a standardised form, representing the focused area(s) for further actions and a time schedule

The first session should take place the first or second time at the latest that the patient presents him/herself to start individual counselling sessions, after randomisation and completion of the full intake procedure. The second session should take place within the same session or the next session at the latest. The third session should follow the next session after the RCQ has been completed. The fourth session could take place in one or two of the following three sessions. The fifth session should take place as soon as possible after the PREDI has been taken off. Then, session 2 and 3 should be repeated consecutively, each time after 4 to 5 weeks. Later PREDI feedback could be given, using graphical representation of evolution in patients' ratings on problems/resources and/or change-wish by focused area(s).

The control group was exposed to treatment as usual, which means that no instruments were used in further individual sessions.

A total of 12 months is needed: the individual counselling sessions for treatment as usual (control group) as well as for the treatment using instruments (experimental group) will take about 6 months and the post-treatment satisfaction measurement will take another 6 months (first sending of questionnaire 3 months after the end of treatment; second sending of questionnaire another 3 months later).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Drop-out rate, decided to at the latest six months after the last individual counselling session of a participant. If a participant did not attend sessions anymore since, it is evaluated as a drop-out.
2. Number of individual counselling sessions, each time the participant is attending an individual counselling session, the date is entered in the data management system. After the participants have left the individual counselling session program or episode, the total number of individual counselling sessions he/she attended can be counted.

Data-entry on frequency, type and intensity of sessions, start and end date of each type of treatment program or episode, as well as the way of leaving the program, into the VPN-based data management system of the De Sleutel network, is part of the normal procedure in the participating outpatient centres and occurs continuously. All this information can be retrieved continuously by the researcher from the system. Definite measurement only can occur six months after the participants’ last individual counselling session, when the clinicians evaluate the way of leaving.

Secondary outcome measures

1. Time in program, this is the number of days between the date of the first individual counselling session and the date of the last individual counselling session attended by the participant, within the same treatment program or episode
2. Way of leaving treatment, decided to at the latest six months after the last individual counselling session of a participant. If a participant did not attend sessions anymore since, it is evaluated as a drop-out.
3. Patient satisfaction with treatment, it is foreseen to let all participants complete the Mental Health Thermometer (MHT) at the end of the individual counselling session program, in case the participant is compliant until that time. Participants that left the program previously are sent the Mental Health Thermometer (MHT) by post-mail about three months after leaving.

Data-entry on frequency, type and intensity of sessions, start and end date of each type of treatment program or episode, as well as the way of leaving the program, into the VPN-based data management system of the De Sleutel network, is part of the normal procedure in the participating outpatient centres and occurs continuously. All this information can be retrieved continuously by the researcher from the system. Definite measurement only can occur six months after the participants’ last individual counselling session, when the clinicians evaluate the way of leaving.

Overall trial start date

15/03/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All patients that presented for help at one of the five outpatient treatment centres of the De Sleutel - network, that completed the full intake-procedure - consisting of at least three sessions which are: a social/medical check-up, the EuropASI-interview and a feedback session on EuropASI with treatment advice - and that are referred to individual counselling sessions at the same outpatient treatment centre, where they presented.

Other criteria:
1. Aged greater than or equal to 18 years, either sex
2. Informed consent
3. Well enough understanding of the Dutch language
4. No psychiatric comorbidity
5. Effective start of the individual counselling sessions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 200

Participant exclusion criteria

Patients referred to another type of treatment than individual counselling sessions (example: medical treatment, substitution therapy, group sessions, daily activation program, etc.)

Recruitment start date

15/03/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Belgium

Trial participating centre

De Sleutel
Gent
B-9000
Belgium

Sponsor information

Organisation

Ghent University (Belgium)

Sponsor details

Department of Family Medicine and Primary Health Care
University Hospital - 1K3
De Pintelaan 185
Gent
B-9000
Belgium
+32 (0)9 332 35 42
jan.demaeseneer@UGent.be

Sponsor type

University/education

Website

http://www.primarycare.ugent.be

Funders

Funder type

Charity

Funder name

De Sleutel, n.p.o. Provincialat of the Brothers of Charity (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ghent University (Belgium) - Department of Family Medicine and Primary Health Care

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21609504

Publication citations

  1. Results

    Raes V, De Jong CA, De Bacquer D, Broekaert E, De Maeseneer J, The effect of using assessment instruments on substance-abuse outpatients' adherence to treatment: a multi-centre randomised controlled trial., BMC Health Serv Res, 2011, 11, 123, doi: 10.1186/1472-6963-11-123.

Additional files

Editorial Notes