Condition category
Mental and Behavioural Disorders
Date applied
10/06/2009
Date assigned
15/07/2009
Last edited
15/07/2009
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

Prof Cor DeJong

ORCID ID

Contact details

Radboud Universiteit Nijmegen
NISPA/ACSW
Postbus 9104
Nijmegen
6500
Netherlands
+31 (0)24 361 1150
c.dejong@acsw.ru.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A multicentre randomised controlled trial to investigate the add-on effect of family involvement in cognitive behavioural therapy patients with a substance use disorder: the you've got family trial

Acronym

Study hypothesis

The main focus of this study is to improve adherence from the lifestyle training by adding family meetings to the lifestyle training. The main study parameter is the proportion of patients finishing treatment (the lifestyle training). A patient finished the treatment when he or she attended the last session of the lifestyle training. We hypothesise that family involvement will increase patient adherence in the lifestyle training.

Ethics approval

Ethics Board of the Medisch Spectrum Twente approved on the 27th April 2009 (ref: NL27609.044.09)

Study design

Multicentre randomised 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

Addiction, substance abuse

Intervention

A non-pharmacological treatment. In the experimental group, the treatment consists of the modules "lifestyle training III or IV", family meetings will be held with a significant other person present. The treatment of the control group consists of the same treatment module, but does not incorporate the family meetings.

In the experimental group the first family meeting treatment will be held after the first session of lifestyle training III. At the end of the treatment period the second family meeting will be held before the last session (= 6) of lifestyle training III. The first session consists a short explanation of the lifestyle training and the importance of giving support to the patient during treatment to enhance treatment compliance. In this session a form of psycho-education concerning substance abuse will be given. The second session is to evaluate the giving of support, answering questions and sharing experiences. In the lifestyle training IV, the first family meeting treatment will be held after the first session of lifestyle training IV. The second session will be held before the sixth session. At the end of the treatment period the last family meeting will be held before the last session (= 12) of lifestyle training IV.

At least seven months are needed: approximately four months of treatment and a three-month post-treatment follow up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proportion of patients finishing treatment (the lifestyle training). A patient has finished the treatment when he or she attended the last session of the lifestyle training.

Measured after treatment measurement (after four months, during the last session of the Lifestyle training.

Secondary outcome measures

1. Number of sessions (percentage) attended by patients
2. Reduction of substance use (measured with the Meten van Addicties voor Triage en Evaluatie [MATE])
3. Improving quality of life (measured with the European Quality of Life Instrument [EuroQOL/5D], and 28-item General Health Questionnaire [GHQ-28])
4. Patient (measured with the GGZ thermometer) and family satisfaction (measured with the Family Contact, Information and Support [Family CIS], Family Member Impact Scale [FMIS] and Hopefulness-hopelessness scale [HOPE])

Measured after treatment measurement (after four months, during the last session of the Lifestyle training.

Overall trial start date

01/04/2009

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

The patients who belong to the population of this study have been presented at one of the four Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA) members for their substance use problem and undergo at this institution an out-patient treatment. All patients eligible for the lifestyle training and fulfilling inclusion criteria are invited to participate this study.

Characteristics of the participant to be included into the lifestyle training III:
1. The participant uses one of the following substances in a problematic way: cannabis, alcohol, cocaine, 3,4-methylenedioxymethamphetamine (MDMA - also known as ecstasy), amphetamines, medicines, or there are problems with gambling
2. The participant has never or only once been treated for his or her problems with the substance or with gambling
3. The social integration is average to very well. This can be shown by several facts, for example the presence of an average to strong social network and activities to fill the daily hours.

Characteristics of the participant to be included into the lifestyle training IV:
1. The participant uses one or more of the following substances in a problematic way: cannabis, alcohol, cocaine, ecstasy, amphetamines, heroine, medicines, or there are problems with gambling (sometimes combined with problematic substance use)
2. The participant has at least twice been treated for his or her addiction problems in a treatment that was less intensive and not successful
3. The participant has not been treated more than once for addiction problems, but has a very severe addiction and/or a lot of comorbid psychopathology

Other criteria:
1. Informed consent
2. Between 18 and 65 years of age, either sex
3. Have a well enough understanding of the Dutch language to fulfil the questionnaires

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144

Participant exclusion criteria

Insufficient capacity to speak and read the Dutch language

Recruitment start date

01/04/2009

Recruitment end date

01/04/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Radboud Universiteit Nijmegen
Nijmegen
6500
Netherlands

Sponsor information

Organisation

Radboud University Nijmegen (Netherlands)

Sponsor details

Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA)/ACSW
PO Box 9104
Nijmegen
6500
Netherlands
+31 (0)24 361 1150
d.groenen@acsw.nu.nl

Sponsor type

University/education

Website

https://www.nispa.nl

Funders

Funder type

University/education

Funder name

Radboud University Nijmegen (Netherlands)

Alternative name(s)

Radboud University, Radboud University Nijmegen, RU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

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

Publication citations

Additional files

Editorial Notes