Clinical trial NCT05833503: Integrative Couple Treatment for Gambling/Substance Use Disorder
Official title: Efficacy Study of Two Types of Intervention for People in Couple Who Have Difficulties With Their Gambling Habits or Alcohol/Drug Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gambling Disorder
Substance Use Disorders
Keywords: Gambling Disorder
Substance use Disorder
Couple-based intervention
Marital relationship
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Université du Québec a Montréal
name: Université de Sherbrooke
name: Laval University
name: Université de Montréal
First posted: 2023-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either Integrative Couple Therapy for Addiction (ICT-A, experimental group) or the usual individual treatment (control group).
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare couple-based treatment to individual treatment (treatment as usual) for addiction (gambling or substance use disorder).

Detailed description: Background:Couple-based intervention is one of the clinical innovations to increase access, retention and effectiveness of treatment in the field of addiction.Couple-based intervention for the treatment of problems related to gambling or substance use disorder (GD/SUD) is more effective than no treatment and the subjective experience of the members of the couple illustrates important clinical gains (better understanding addiction, resolve conflicts, etc.). A study conducted by the research team revealed a better effectiveness of couple-based treatment for GD than the individual treatment usually offered. Despite these positive results, this study highlighted a need to improve the couple intervention model (Integrative Couple Treatment for Pathological Gambling- ICT-PG). First of all, it did not allow to reach people having a SUD. Previous studies conducted by the research team also illustrated the need for more clinical work on serious relationship injuries caused by gambling. The investigators also accentuated their work on the strategies used by the partners and having an impact on the gambler's gambling behaviors.

Goal : Evaluate the effectiveness of a couple-based treatment (Integrative Couple Therapy for Addiction ICT-A; experimental group) compared to the individual treatment usually offer (control group) for people with GD/SUD.

Method/Design : A sample of at least 100 couples will be randomized to either ICT-A (experimental group) or the usual individual treatment (control group). The couple treatment called Integrative Couple Therapy for Addiction (ICT-A) is inspired by the "Alcohol Behavior Couple Therapy" from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling or substance use behaviors, b) helping the partner to stop behaviors facilitating gambling habits or substance use and rise the frequency of behaviors incompatible with gambling habits or substance use c) improve marital components (communication, sharing positive moments, negotiation, mutual support).The control group receives individual treatment as already offered by the specialized centers in addiction. All participants are recruited in Specialized Addiction Treatment Centers in Quebec Province, Canada. Repeated measures will be conducted at admission, 6, 12 and 18 months post-admission on the addiction's severity (primary outcome), on various couples' dimensions (secondary outcome) and various indicators of personal well-being (secondary outcome).In order to compare the effectiveness of the two treatment modalities, a series of regression analyzes will be carried out taking into account the correlation between the observations for the same individual and measurements repeated over time (linear mixed models; PROC MIXED of SAS).

Eligibility criteria: Inclusion Criteria:

* The Gambler may have a gambling or substance use problem at the beginning of treatment AND is accepted for treatment by addiction rehabilitation centers (CRDs).
* The Gambler has engaged in gambling or substance use behaviors in the past three months (Time Line Follow-Back).
* The Partner may or may not engage in gambling, consume alcohol or other substances of abuse.
* Living in couple for at least six months OR report being in a significant relationship for at least two years.
* Neither member of the couple presents a mental health problem that could hinder their ability to participate in the therapeutic process.

Exclusion Criteria:

* The Gambler has been completely abstinent from any gambling or substance use problem for the past three months.
* The Gambler received treatment for gambling disorder or substance abuse disorder during the last six months (excluding Gamblers Anonymous, Alcoholics Anonymous or Narcotics Anonymous).
* Low level of marital commitment between the couple in the past 2 weeks indicating a high risk of short-term separation (Marital Status Inventory, score ≥9)
* Presence of serious acts of violence committed within the past year endangering the safety or life of one of the spouses (Modified Conflict Tactics Scales: Answer YES to any question from Q27-33) OR use of services for victims of domestic violence in the past year.
* Presence of an active mental health disorder in either partner hindering therapeutic participation, such as a psychotic disorder OR a suicide attempt in the last 30 days (Psychological Scale of the Addiction Severity Index) OR severe borderline personality disorder (BSL-23 ≥2.8) OR excessively extreme antisocial behaviors (Conduct Disorder Scale from the GAIN ≥ 9).

Primary outcomes:
measure: Change in Self-reports of alcohol, substance use and gambling with the Time-Line Follow-Back (TLFB) in the last 90 days-Gamblers
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Canadian Problem Gambling Severity Index (PGSI)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Alcohol, Smoking and Substance involvement and Screening Test (ASSIST) of the World Health Organization (WHO)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Negative Gambling/Using Consequences-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Negative Gambling/Using Consequences-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Severity of dependance scale (SDS)-Gamblers
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Craving Experience Questionnaire (CEQ)-Gamblers
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Readiness to Change Questionnaire (RCQ)-Gamblers
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Readiness Ruler tool-Gambler
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Global Improvement Rate-Gambler
timeFrame: in the last six months of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Global Improvement Rate-Partner
timeFrame: in the last six months of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Inventory of Erroneous Beliefs Related to Gambling ("Inventaire Des Croyances liées Aux Jeux" - ICROLJ)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Inventory of Erroneous Beliefs Related to Gambling ("Inventaire Des Croyances liées Aux Jeux" - ICROLJ)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in integrative evaluation specialized in addiction (évaluation intégrative spécialisée en dépendance)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
Secondary outcomes:
measure: Change in Affective Reserve-Gambler
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Affective Reserve-Partner
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Conflict Tactics Scale-2_Psychological Violence Issued by the Spouse-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Conflict Tactics Scale-2_Psychological Violence Issued by the Spouse-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Marital Status Inventory (MSI)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Marital Status Inventory (MSI)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Dyadic Adjustment Scale (DAS-4)-Gambler
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Dyadic Adjustment Scale (DAS-4)-Partner
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Conjugal Support Questionnaire(CSQ)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Conjugal Support Questionnaire(CSQ)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Gratitude Questionnaire (GQ-6)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Gratitude Questionnaire (GQ-6)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Generosity Scale-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Generosity Scale-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in World Health Organisation-Five Well-Being Index (WHO-5)-Gambler
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in World Health Organisation-Five Well-Being Index (WHO-5)-Partner
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Psychological Distress Index from the Quebec Health Survey-Gambler
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Psychological Distress Index from the Quebec Health Survey-Partner
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Ways of Coping Questionnaire-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Ways of Coping Questionnaire-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in History of Psychiatric Hospitalization-Gambler
timeFrame: in the last six months of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in History of Psychiatric Hospitalization-Partner
timeFrame: in the last six months of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Judicial sphere-Gambler
timeFrame: in the last six months of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Judicial sphere-Partner
timeFrame: in the last six months of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in History of addiction treatment-Gambler
timeFrame: in the last six months of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Empathic Concern subscale from the Interpersonal Reactivity Index (IRI-Short form)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Empathic Concern subscale from the Interpersonal Reactivity Index (IRI-Short form)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Alcohol, Smoking and Substance Involvement and Screening Test (ASSIST) of the World Health Organization (WHO)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Canadian Problem Gambling Severity Index (PGSI)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Strategies facilitating the cessation of gambling and/or substance use behaviors and strategies promoting gambling and/or substance use behaviors-Partners
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Attribution scale for my spouse's gambling and/or substance use behaviors-Partners
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Transgression-Related Interpersonal Motivations-18 (TRIM-18)-Partners
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Level of trust in the partner
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Self-Forgiveness Dual-Process Scale-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in The Brief Accessibility, Responsiveness and Engagement (BARE)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Interaction about addiction-Gambler
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Communication about cravings and use behaviors of substances and/or gambling
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Communication Patterns Questionnaire (CPQ)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Couples Communication Satisfaction Scale (CCSS)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Marital Problem Solving Scale (MPSS)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Substance Use Recovery Evaluator (SURE)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in World Health Organization Quality of Life Assessment Brief (WHOQOL)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Snyder's State Hope Scale (SHS)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Social Provisions Scale (SPS-10)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Social Provisions Scale (SPS-10)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in World Health Organization Quality of Life Assessment Brief (WHOQOL)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Scale of perception of gambling and/or substance use and involvement for those around them-for Partners
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Barriers to Forgiveness Scale (BFS)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in State Shame and Guilt Scale (SSGS)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in The Brief Accessibility, Responsiveness and Engagement (BARE)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Couples Communication Satisfaction Scale (CCSS)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Self-care questionnaire (Tremblay, 2022)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Self-care questionnaire (Tremblay, 2022)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Marital Problem Solving Scale (MPSS)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Communication Patterns Questionnaire (CPQ)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Interaction about addiction-Partner
timeFrame: in the last seven days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in The Experience in Close Relationship Scale short-form (ECR-S)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in The Experience in Close Relationship Scale short-form (ECR-S)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Dyadic Trust Scale (DTS)-Partner
timeFrame: in the last seven days prior to admission, 6, 12 and 18 post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Dyadic Trust Scale (DTS)-Gambler
timeFrame: in the last seven days prior to admission, 6, 12 and 18 post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Conflict Tactics Scale-2 _ Physical Violence Issued by the spouse-Gamblers
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Conflict Tactics Scale-2 _ Physical Violence Issued by the spouse-Partners
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Perspective Taking subscale from the Interpersonal Reactivity Index (IRI-Short form)-Gambler
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Perspective Taking subscale from the Interpersonal Reactivity Index (IRI-Short form)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
measure: Change in Substance Use Recovery Evaluator (SURE)-Partner
timeFrame: in the last 90 days of admission, 6,12 and 18 months post-admission (The first admission is anticipated for april 2023 and the last in march 2024)
Other outcomes:
Locations:
city: Joliette
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux de Lanaudière
state: Quebec
city: Lévis
country: Canada
facility: Centre intégré de Santé et de Services Sociaux de Chaudière-Appalaches (CISSS-CA)
state: Quebec
city: Montréal
country: Canada
facility: Centre Universitaire Intégré de Santé et de Services Sociaux du Centre Sud de l'Ile de Montréal
state: Quebec
city: Saint-Jérôme
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux des Laurentides
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Universitaire Intégré de Santé et de Services Sociaux de l'Estrie
state: Quebec
city: St-Hubert
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Ouest
state: Quebec
city: Québec
country: Canada
facility: Centre Universitaire Intégré de Santé et de Services Sociaux de la Capitale Nationale
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Joël Tremblay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mccullough ME, Emmons RA, Tsang JA. The grateful disposition: a conceptual and empirical topography. J Pers Soc Psychol. 2002 Jan;82(1):112-27. doi: 10.1037//0022-3514.82.1.112.