NCT05833503

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).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

February 10, 2023

Last Update Submit

April 8, 2024

Conditions

Keywords

Gambling DisorderSubstance use DisorderCouple-based interventionMarital relationship

Outcome Measures

Primary Outcomes (14)

  • Change in Self-reports of alcohol, substance use and gambling with the Time-Line Follow-Back (TLFB) in the last 90 days-Gamblers

    Outcome measure for Gamblers The TLFB evaluates the frequency and quantity of substance consumed (alcohol, cannabis, other drugs) and gambling behaviours in the last 90 days, based on the personal definition of each user (none, low, moderate, high).

    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)

  • Change in Canadian Problem Gambling Severity Index (PGSI)-Gambler

    Outcome measure for Gamblers The Canadian Problem Gambling Index (CPGI) is a 9-item measure with a 4-point Likert-type scale (0 = Never, 3 = Almost always). It asks questions about the gambler's habits from four categories: Gambling involvement; Problem gambling behaviour; Adverse Consequences; Correlates of problem gambling. Scores for the nine items are summed, and the results are interpreted as follows: 0 = non-problem ; 1-4 = low risk; 5-7 = moderate risk; 8 and + (maximum 27) = probable pathological player.

    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)

  • Change in Alcohol, Smoking and Substance involvement and Screening Test (ASSIST) of the World Health Organization (WHO)-Gambler

    Outcome measure for Gamblers This 8-item tool is developed by a group of the World Health Organization (WHO) specialized in addiction. It detects the use of different substances from the gambler and proposes a threshold above which reported consumption behaviors are problematic (low risk: 0-3 for drug use and 0-10 for alcohol use, moderate risk: between 4-26 for drug use and between 11-26 for alcohol use, high risk 27 and more for alcohol and drug use).

    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)

  • Change in Negative Gambling/Using Consequences-Gambler

    Outcome Measure for Gamblers This short questionnaire of 7 items assesses to what extent the respondent considers his gambling/using habits in the last 3 months have harmed various aspects of his life (financial, living conditions, marital, physical health, professional life, social, legal and family). Participants are asked to respond on a scale where "0" corresponds to "not at all" or "never", while "10" corresponds to "extremely" or "always". To compute a total score, all item' score are summed. The total score ranges from 0 to 70.The higher the score, the more it indicates that the person is experiencing negative impacts due to their GD/SUD.

    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)

  • Change in Negative Gambling/Using Consequences-Partner

    Outcome Measure for Partners This short questionnaire of 7 items assesses to what extent the respondent considers that his partner's gambling/using habits have harmed various aspects of his life in the last 3 months (financial, living conditions, marital, physical health, professional life, social, legal and family). Participants are asked to respond on a scale where "0" corresponds to "not at all" or "never", while "10" corresponds to "extremely" or "always". To compute a total score, all item' score are summed. The total score ranges from 0 to 70. Higher the score is, more it's indicate that the respondent is experiencing negative impacts because of his partner's gambling habits.

    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)

  • Change in Severity of dependance scale (SDS)-Gamblers

    Outcome measure for Gamblers This brief questionnaire is designed to measure the severity of a person's addiction. The tool includes 5 items concerning the psychological dimensions of addiction (loss of control, concern about use or gambling behaviors). Each question is scored either 0 (Never or almost never),1(Sometimes), 2 (Often), or 3 (Always). A total score is calculated by summing the responses to all five questions. The minimum total score possible is 0, and the maximum total score possible is 15 (i.e. total score range: 0-15). A higher total score indicates a higher level of dependence.

    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)

  • Change in Craving Experience Questionnaire (CEQ)-Gamblers

    Outcome measure for Gamblers The CEQ was developed based on intrusion theory, which conceives of craving as a cognitive-emotional phenomenon that begins with an intrusive and generally spontaneous thought (triggered by external or internal cues) followed by a cognitive process involving the construction of multi-sensory images. The CEQ-forces cravings consists of 10 items assessing craving intensity, images, and thought intrusion. The 4 items covering imagery, scent, taste and mouth/throat sensation have been adapted into three items to better reflect the experience of craving with gambling. The CEQ is a 10-items questionnaire that measures the intensity craving (i.e. the irrepressible urge to consume a substance) in the last 7 days. Each item is rated from 0 (Not at all) to 10 (Extremely). Total scores summarise strength of craving, which can range between 0 and 100. The higher the score, the more the craving felt by the participant is considered intense.

    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)

  • Change in Readiness to Change Questionnaire (RCQ)-Gamblers

    Outcome measure for Gamblers The RCQ is a 12-item instrument used for identifying the "stage of change" of someone having an addiction problem, which are : precontemplation (PC), contemplation (C) and action (A). Questions assess the degree of motivation to change substance use and/or gambling habits. The respondent answers with -2 (Strongly disagree), -1 (Disagree), 0 (Unsure), +1 (Agree), +2 (Strongly Agree). The item score for each scale (PC, C and A) is summed, meaning the total score should be within the range -8 to +8. The scale with the highest score is the one that determines the stage of motivation to change.

    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)

  • Change in Readiness Ruler tool-Gambler

    Outcome measure for Gamblers The instrument has two items, one to estimate how important people with problematic use feel it is to change their behaviors, and another to estimate how capable they feel they are of changing their behaviors, reflecting their sense of competence in changing their behavior or their perceived ability to change.Responses are distributed along a continuum from 0 to 10 where "0" represents "not at all," "5" means "moderately" and "10" represents "extremely." Higher the score is for each scale, respectively, the higher the level of importance and the level of confidence about making this change.

    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)

  • Change in Global Improvement Rate-Gambler

    Outcome measure for Gamblers This scale (of one question only) is used to document the perceived improvement in terms of difficulties in controlling one's gambling and substance use behaviors according to the treatment received. On a 7-point Likert scale (1 = very great degradation; 4 = no change; 7 = very great improvement), the individual evaluates the extent to which he has changed their gambling and substance use compared to prior the treatment. The closer the score is to 7, the more progress the person feels he or she has made, while a score close to 4 indicates no change and a score close to 1 indicates that the situation has worsened (max=7, min=0).

    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)

  • Change in Global Improvement Rate-Partner

    Outcome measure for Partners This scale (with a single question) is used to document the improvement perceived by the partner about his gambler spouse in terms of difficulties in controlling his gambling and consumption behaviors according to the treatment received. On a 7-point Likert scale (1 = very great degradation; 4 = no change; 7 = very great improvement). The individual assesses the extent to which his or her partner has changed his or her gambling and substance use patterns from before treatment. The closer the score is to 7, the more the person feels that his or her spouse has made progress, while a score close to 4 indicates no change and a score close to 1 that the situation has deteriorated (max=7, min=0).

    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)

  • Change in Inventory of Erroneous Beliefs Related to Gambling ("Inventaire Des Croyances liées Aux Jeux" - ICROLJ)-Gambler

    Outcome Measure for Gamblers This questionnaire measures people's beliefs about gambling. The ICROLJ has 30 items and uses a 4-point Likert-type scale ranging from "Strongly disagree" = 0 to "Strongly agree"=4. To compute a total score, all item' score are summed. The total score ranges from 0 to 120.Higher the score is, more it indicates the presence of erroneous beliefs.

    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)

  • Change in Inventory of Erroneous Beliefs Related to Gambling ("Inventaire Des Croyances liées Aux Jeux" - ICROLJ)-Partner

    Outcome Measure for Partners This questionnaire measures people's beliefs about gambling. The ICROLJ has 30 items and uses a 4-point Likert-type scale ranging from "Strongly disagree" = 0 to "Strongly agree"=4. To compute a total score, all item' score are summed. The total score ranges from 0 to 120. Higher the score is, more it indicates the presence of erroneous beliefs.

    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)

  • Change in integrative evaluation specialized in addiction (évaluation intégrative spécialisée en dépendance)-Gambler

    Outcome Measure for Gamblers This questionnaire measures different dimensions of the addiction problem (consequence, psychic invasion, preoccupation, loss of control, craving, withdrawal, unpleasant emotional motivation). Generally composed of 18 items, we removed the items that were already in the questionnaire on consequences, for a total of 13 items scored on a scale from 0 to 10 (0= not at all, 10=extremely). To compute a total score, all item' score are summed. The total score ranges from 0 to 130. The higher the score, the more severe the disorder.

    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 (65)

  • Change in Affective Reserve-Gambler

    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)

  • Change in Affective Reserve-Partner

    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)

  • Change in Conflict Tactics Scale-2_Psychological Violence Issued by the Spouse-Gambler

    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)

  • Change in Conflict Tactics Scale-2_Psychological Violence Issued by the Spouse-Partner

    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)

  • Change in Marital Status Inventory (MSI)-Gambler

    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)

  • +60 more secondary outcomes

Study Arms (2)

Integrative Couple Treatment for Addiction (ICT-A)

EXPERIMENTAL

Inspired by the "Alcohol Behavior Couple Therapy" from Epstein \& McCrady, the ICT-A will be offered over 12 to 16 sessions of 90 minutes. Typically, approximately the first half of each session is dedicated to GD/SUD problems,in a predominantly cognitive behavioral model. In the second part of each session, the clinician will help the couple to improve their communication,to reduce the reinforcements (non-voluntary) of the behaviors of GD/SUD and to increase marital pleasure situations incompatible with the use of GD/SUD.Particular attention will also be paid to feelings of betrayal and interpersonal attacks to restore trust. Plus,they will received a sefl-care guide.

Behavioral: Integrative Couple Treatment for Addiction (ICT-A)

Individual treatment as usually offered

ACTIVE COMPARATOR

The usual treatment control group will receive individual treatment as already offered by the specialized centres in addiction. For the person with GD/SUD, this treatment consists of 12 to 16 individual cognitive-behavioral sessions of 60 minutes. In general, the intervention aims to secure financial assets, awareness of erroneous thoughts and improvement of alternative skills to gambling in order to meet the normal demands of psychic and relational life. People undergoing this intervention will receive a self-care guide. As for the partners randomized in this intervention, they will receive the services that are usually offered to members of the entourage of a person with GD/SUD. In groups or individually, these services are generally aimed at improving the partner's well-being and relationship with their spouse, which includes information about GD/SUD and the recovery process.

Behavioral: Treatment individual as usually offered

Interventions

Couple-based intervention called Integrative Couple Treatment for Addiction (ICT-A).

Also known as: Couple therapy
Integrative Couple Treatment for Addiction (ICT-A)

Individual-based treatment as usually offer by the specialized centres in addiction.

Also known as: Treatment as usual (TAU)
Individual treatment as usually offered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre Intégré de Santé et de Services Sociaux de Lanaudière

Joliette, Quebec, J6E 5X7, Canada

RECRUITING

Centre intégré de Santé et de Services Sociaux de Chaudière-Appalaches (CISSS-CA)

Lévis, Quebec, G6V 0M4, Canada

RECRUITING

Centre Universitaire Intégré de Santé et de Services Sociaux du Centre Sud de l'Ile de Montréal

Montreal, Quebec, H2L 4M1, Canada

RECRUITING

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Ouest

Saint-Hubert, Quebec, J3Y 6W9, Canada

RECRUITING

Centre Intégré de Santé et de Services Sociaux des Laurentides

Saint-Jérôme, Quebec, J7Z 5T3, Canada

RECRUITING

Centre Universitaire Intégré de Santé et de Services Sociaux de l'Estrie

Sherbrooke, Quebec, J1G 1B1, Canada

RECRUITING

Centre Universitaire Intégré de Santé et de Services Sociaux de la Capitale Nationale

Québec, G1J 0A4, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 11811629BACKGROUND

MeSH Terms

Conditions

GamblingSubstance-Related Disorders

Interventions

Couples TherapyTherapeutics

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joël Tremblay, PhD

    Université du Québec à Trois-Rivières

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joël Tremblay, PhD

CONTACT

Myriam Beaulieu, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
These are two behavioral treatments.It is therefore impossible to mask the allocation of participants to either treatment, for both participants and clinicians.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to either Integrative Couple Therapy for Addiction (ICT-A, experimental group) or the usual individual treatment (control group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Professor to department of psychoeducation

Study Record Dates

First Submitted

February 10, 2023

First Posted

April 27, 2023

Study Start

May 1, 2023

Primary Completion

August 1, 2025

Study Completion

February 1, 2026

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations