Group Version of CRAFT Compared to Self-Directed CRAFT Delivery and Non-intervention: a Three-armed RCT

Alcohol Use Disorder Clinical Trial

Official title:

A Group Version of Community Reinforcement and Family Training (CRAFT) Compared to Self-Directed CRAFT Delivery and Non-intervention: a Three-armed Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02510508
• Other study ID #: NL48307.028.14
• Status: Terminated
• Phase: N/A
• First received: July 16, 2015
• Last updated: August 16, 2017
• Start date: August 2015
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: IrisZorg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine whether a group format Community Reinforcement and Family Training (CRAFT) and Self-Directed CRAFT Delivery are more effective than non-intervention in terms of Concerned Significant Others (CSO) well- being and cost- effectiveness.

Description:

The aim of this study is to determine the applicability and effectiveness of (a) CRAFT group format in conjunction with the CRAFT self-help book and (b) a CRAFT self-help book (self-directed CRAFT delivery condition), compared to (c) non-intervention (control). The primary aim is increase CSO well- being and reduce CSO health complaints. CSOs will be assessed at baseline (T0), 2 months (end of intervention) (T1), 3 months- (T2), and 6 months follow-up (T3), independently of the assigned condition. Secondary outcomes will encompass cost-effectiveness of both CRAFT interventions. Also, we measure IP engagement and IPs' substance use.

Since the negative consequences of substance abuse are not limited to alcohol- and drug users themselves, it also affects the lives of family members and close friends (CSOs). This study focusses on CSOs to improve their lives. Recruitment will take place in the Netherlands (nation- wide). Assessment and the CRAFT group intervention will be conducted at six different locations (Arnhem, Doetinchem, Ede, Nijmegen, Tiel and Zevenaar, all in the province of Gelderland) in the Netherlands. Participants will be recruited via advertisements on the Internet, social media, websites of IrisZorg (centre for addiction care and sheltered housing ), and subsequently, in local newspapers and flyers located in emergency rooms, general practitioners, family practice clinics, and mental health based treatment agencies.

To obtain information about the presence of psychiatric disorders of the CSOs, a Dutch version of the Mini-International Neuropsychiatric Interview (M.I.N.I.) will be used. After initial assessment, a randomization procedure will be conducted by an independent researcher, who is affiliated to the Erasmus Medical Center, Rotterdam, the Netherlands. CSOs will be informed about the allocation of conditions within 1 week, after initial admission. Several outcome measures will be used in this study. The following will be measured:

1. CSO well- being (including physical and psychological health and complaints, quality of life, quality of the relationship, self- efficacy and social support);

2. cost-effectiveness of both CRAFT and Self- Directed Delivery compared to non- intervention.

3. IP engagement and IP substance use.

Using the primary outcome, CSO well-being, a priori power analysis is completed. Means and standard deviations for CSO well-being, measured with the Beck Depression Inventory (BDI), for Group CRAFT were used (Miller et al., 1999). An effect size was calculated (f = 0.22). The power analysis, conducted with the online program called G-power, indicated that a total sample size of 69 CSOs is needed to achieve a power of 95% for detecting a medium effect size when using the p = 0.05 criterion of statistical significance. These numbers are based on an ANOVA with a within-between subject design. Based on the pilot study of Kirby et al. (1999), 23% drop out after 3- and 6- month follow-up is taken into account. This means that, including the 23% drop-out-rate and based on the sample size of 69, an N of 85 is needed after 3 months and that a total N of 105 is needed to complete all assessments. Summarized, to be able to have at least 69 assessments completed at 6- month follow- up, a total sample size of 105 CSOs is required; with an estimated total drop-out rate of 34%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CSO has concern about and having direct knowledge of alcohol- and/or drug problems of an IP, who is either a first degree relative, intimate partner or close friend.

• Age at least 18 years (the CSO)

• Reports that IP is not currently in addiction treatment (at IrisZorg and elsewhere) and has not received addiction treatment in the past 3 months

• Reports that IP is treatment-refusing

• Evidence (according CSO) that the IP meets criteria for SUDs according to The Structured Clinical Interview for DSM IV axis 1 Disorders (SCID-I)

Exclusion Criteria:

• Does not demonstrate an adequate understanding of their participation, informed consent, and requirements of the protocol, or has insufficient reading abilities to comprehend the Dutch self-help book or does not agree to participate by refusing to sign an informed consent

• CSO meets the DSM-IV criteria for any current SUD diagnosis, through clinical assessment by The Structured Clinical Interview for DSM IV axis 1 Disorders (SCID-I) and the Dutch version of the Mini- International Neuropsychiatric Interview ( M.I.N.I.)

• Refuses to provide valid locator information, allow audiotaped sessions, and/or participate in follow-ups

• Evidence that the IP had received treatment (other than detoxification) for alcohol or drug problems in the prior three months, was mandated by the courts to receive treatment, or was currently motivated to accept treatment

• IP has a recent history of severe domestic violence

• CSO is involved in a concomitant intervention to get the IP in treatment or to improve their own well-being

• CSO fails to complete less than 4 Group CRAFT sessions

Related Conditions & MeSH terms

• Addiction
• Alcohol Use Disorder
• Behavior, Addictive
• Disease
• Substance Use Disorder
• Substance- Related Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Group CRAFT
CSOs will receive seven weekly 90 min sessions of CRAFT + Self-Directed CRAFT Delivery
• Self-Directed CRAFT Delivery
CRAFT self-help book (Self Directed CRAFT Delivery)

Other:
• Non-intervention
Non-intervention

Locations

Country	Name	City	State
Netherlands	IrisZorg	Arnhem	Gelderland
Netherlands	IrisZorg	Doetinchem	Gelderland
Netherlands	IrisZorg	Ede	Gelderland
Netherlands	IrisZorg	Nijmegen	Gelderland
Netherlands	IrisZorg	Tiel	Gelderland
Netherlands	IrisZorg	Zevenaar	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
IrisZorg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identified Patient (IP) engagement for all three conditions	Attending at least 1 treatment session	4 months after the initiation of the intervention
Other	CSO Drop-out	Drop-out and treatment retention	4 months after the initiation of the intervention
Primary	Concerned Significant Other (CSO) well-being (physical and psychological)	Measured by the following tests:Measurement of the Addictions for Triage and Evaluation (MATE), Depression Anxiety Scales (DASS-21), Maudsley Addiction Profile (MAP), Research and Development- 36 (RAND- 36), Trimbos/iMTA questionnaire for Costs Associated with Psychiatric Illness (TicP) and EuroQol- 5D.	4 months after the initiation of the intervention
Secondary	CSO quality of life	Measured by the following tests: CRA- Happiness Scale (CRA-HS) and WHOQol- Bref	4 months after the initiation of the intervention
Secondary	CSO quality of the relationship	Measured by the following tests: CRA Relationship Happiness Scale (CRA-RHS), Agression Questionnaire (AQ) and Experiences in Close Relationships Scale- short form (ECR)	4 months after the initiation of the intervention
Secondary	Other CSO reported psychological measures	Measured by the following tests: General Self-Efficacy Scale (GSES) and Social Support Inventory (SSI).	4 months after the initiation of the intervention
Secondary	Cost-effectiveness of group CRAFT and Self-Directed CRAFT Delivery compared to non-intervention condition	Measured by: TiC-P; EuroQol- 5D and RAND-36	4 months after the initiation of the intervention