Pathological GamblingICT-PGNCT02240485
Integrative Couple Treatment for Pathological Gambling
A study testing Integrative Couple Treatment for Pathological Gambling (ICT-PG) and Usual individual/group treatment in people with Pathological Gambling, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
The aim of the study is to compare marital treatment to individual treatment for pathological gambling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Integrative Couple Treatment for Pathological Gambling (ICT-PG) and Usual individual/group treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2011to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living together for at least 1 year
- Diagnosis of pathological gambling (WMH-CIDI) during the last 12 months
- The gambler has not received treatment for their gambling for at least 6 months (excluding GA)
- Presence of gambling behavior in the past 3 months
- Degree of commitment to the couple indicating a desire to continue the relationship (score of 7 - MSI)
Who cannot join
- Alcohol/Drug Dependence gambler/partner (Severity of Alcohol Dependence Data questionnaire - SADD >17 included in DEBA-A; Severity of Dependence Scale - SDS > 5 Included in DEBA-D)
- Gambling problem for the partner (DEBA-Jeu > 10)
- Presence of serious acts of violence endangering the safety of both spouses (CTS-2)
- Disorder and serious mental health unstabilized one of two members of the couple (ASI: psychological scale)
- Antisocial personality disorder or severe limit ( GAIN: 9 + Scale BCS / CDS)
- Scenario with strong suicidal ideation or attempt in the last 30 days or less in the partner (ASI: psychological scale)
- Low degree of commitment in the relationship of a risk of separation (8 + MSI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrative Couple Treatment for Pathological Gambling or Individual Treatment: A Comparison of Efficacy
The aim of the study is to compare marital treatment to individual treatment for pathological gambling.
Read the detailed description
The study as two goals: evaluate the efficacy of couple treatment for pathological gambling and develop a better understanding of the individual (substance use, mental health) and couple dimensions (communication, marital satisfaction, violence) as intermediate variables explaining this efficacy. Couples will be randomized between the couple treatment and the treatment as usual (individual or group). The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Therapy for Pathological Gambling - ICT-PG) 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 behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support).
The control group receives individual or group treatment as already offered by the specialized centers in addiction. Their partner can receive individual intervention if desired. All participants are recruited in Specialized Addiction Treatment Centers in Quebec province, Canada. Evaluation of participants is done at admission, three, nine and 18 months post-admission.
Repeated measures ANOVA will be used to compared evolutions of groups over time. Multiple regression will allow the estimation of components roles into as intermediate variables to predict rehabilitation.
- Conditions
- Pathological Gambling
- Being tested
- Integrative Couple Treatment for Pathological Gambling (ICT-PG), Usual individual/group treatment
- Keywords
- Pathological gambling, Treatment, Marital relationship
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Couple Treatment for Pathological Gambling (ICT-PG)Behavioural
Also called Couple therapy
The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Therapy for Pathological Gambling - ICT-PG) 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 behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support).
Usual individual/group treatmentBehavioural
Also called treatment as usual
The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Couple Treatment for Pathological Gambling (ICT-PG) | Experimental | Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Treatment for Pathological Gambling - ICT-PG) 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 behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support). Receives: Behavioral: Integrative Couple Treatment for Pathological Gambling (ICT-PG) |
| Usual individual/group treatment | Active comparator | Usual individual/group treatment: The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired. Receives: Behavioral: Usual individual/group treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gambling Symptom Assessment Scale (G-SAS)
Outcome measure for Gamblers
The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment.
Each 12-item scale has a score ranging from 0 - 4 (adjective anchors for 0 and 4 vary for each item but "0 means no symptoms" and "4 means extreme symptoms").
All items ask for an average symptom based on the past 7 days (average urge, frequency, duration and control,thoughts associated with gambling,time spent on gambling,anticipatory tension and/or excitement, emotional distress).
The total score ranges from 0 to 48.
A score between 8 and 20 is an indicator of low urges to gamble, between 21 and 30, moderate urges, between 31 and 40 severe urges and a score of over 40 reveals the presence of extreme urges in the player.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Frequency of the Most Problematic Game
Outcome Measure for Gamblers
Among 12 types of gambling activities, the highest frequency of gambling behaviors for the past 6 months (never = 0; every or almost every day=5). Maximum score is 5. The higher is the score, the higher is the frequency.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Detection of Gambling Problems and Services Need ("Détection et Besoin d'Aide en Regard du Jeu Excessif- DÉBA-Jeu")
Outcome Measure for Gamblers
The DEBA-Jeu is a very brief screening grid comprising eight Likert-type items in five points (never = 0, always = 4). The eight items form a scale where the total score varies between 0 and 32. The suggested breaking points are as follows: 0 to 1 = No problem gambling; 2 to 5 =Problem gambling ; 6 to 24 = High probability of problem gambling.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Canadian Problem Gambling Index (CPGI)
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 an individual's gambling habits in the last three months 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.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Canadian Dollars Spent on Gambling
Outcome measure for Gamblers
Total Money spent in canadian dollars for all gambling activities during the last 3 months previous each research interview.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Impaired Control Over Gambling Scale (ICOG)
Outcome Measure for Gamblers
The ICOG is used to measure two aspects of control related to the JHA processes, namely the level of control over the desire to start playing (e.g., when I decide not to play, I watch stick to that decision) as well as the level of control once the game has started (e.g., when I knew I had little time to play, I would limit myself to the scheduled time). This questionnaire has a total of 10 items and uses a 5-point Likert-type scale ranging from "Never = 1" to "Always = 5", with 4 inverted items.
The total score varies between 10 and 50. A high control represents a score between 10 and 16, a moderate control between 17 and 23 and a score of 24 and more presents a low control in the player.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
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 29 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 116.Higher the score is, more it indicates the presence of erroneous beliefs.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Negative Gambling Consequences-Gambler
Outcome Measure for Gamblers
Short questionnaire of 10 items, assessing to what extent the respondent considers his gambling habits in the last 6 months have harmed various aspects of his life (financial, living conditions, marital, physical health, professional life, social, legal and family). A 5-point Likert-type scale is used "Not at all = 0" to "Extremely = 4". To compute a total score, all item' score are summed. The total score ranges from 0 to 40.Higher the score is, more it's indicate that the respondent is experiencing negative impacts because of his gambling habits.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Negative Gambling Consequences-Partner
Outcome Measure for Partners
Short questionnaire of 10 items, assessing to what extent the respondent considers that his partner's gambling habits have harmed various aspects of his life in the last 6 months (financial, living conditions, marital, physical health, professional life, social, legal and family). A 5-point Likert-type scale is used "Not at all = 0" to "Extremely = 4". To compute a total score, all item' score are summed. The total score ranges from 0 to 40. Higher the score is, more it's indicate that the respondent is experiencing negative impacts because of his partner's gambling habits.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
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 29 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 116. Higher the score is, more it indicates the presence of erroneous beliefs.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Secondary outcomes (28)
Conjugal Support Questionnaire (CSQ)-Partner
Outcome Measure for Partners
This questionnaire measure the quality of the support received and given perceived by the two members of the couple. It consists of a total of 8 questions, with a 5-point Likert scale (1 = never; 5 = always).
The total score shows support received and support gave, higher is the result, more it indicates that the member of the couple gave support and receives it (score min = 0 and score max=40).
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Psychological Distress Index (IDPESQ-14)-Partner
Outcome Measure for Partners
This instrument is used to measure psychological distress, including symptoms of depression and anxiety. We used the version of the questionnaire with 14 items. A Likert-type scale ranging from "never = 1" to "very often = 3" is used and the respondent must respond according to their condition during the last seven days. To compute a total score, all item' score are summed. The total score ranges from 0 to 42. A score of 26 and above indicates a high level of psychological distress.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Center for Epidemiologic Studies Depression Scale (CES-D)-Partner
Outcome Measure for Partners
This instrument is used to measure depressive symptoms in an individual. It measures these symptoms as defined in the American Psychiatric Association Diagnostic and Statistical Manual (DSM-IV) for depressive episodes.This questionnaire has 20 items and it assesses how the psychological well-being of the person during the last week. A 4-point Likert-type scale is used ranging from "0 = Never, very rarely (less than a day)" to a rating of "3 = Frequently, all the time (5 to 7 days)" The score can therefore vary from 0 to 60, the higher it is the higher the risk of depression. For a man, a threshold of 17 indicates a risk of depression and for a woman the same threshold is 23.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Psychological Distress Index (IDPESQ-14)-Gambler
Outcome Measure for Gamblers
This instrument is used to measure psychological distress, including symptoms of depression and anxiety. We used the version of the questionnaire with 14 items. A Likert-type scale ranging from "never = 1" to "very often = 3" is used and the respondent must respond according to their condition during the last seven days. To compute a total score, all item' score are summed. The total score ranges from 0 to 42. A score of 26 and above indicates a high level of psychological distress.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Center for Epidemiologic Studies Depression Scale (CES-D)-Gambler
Outcome Measure for Gamblers
This instrument is used to measure depressive symptoms in an individual. It measures these symptoms as defined in the American Psychiatric Association Diagnostic and Statistical Manual (DSM-IV) for depressive episodes.This questionnaire has 20 items and it assesses how the psychological well-being of the person during the last week. A 4-point Likert-type scale is used ranging from "0 = Never, very rarely (less than a day)" to a rating of "3 = Frequently, all the time (5 to 7 days)" The score can therefore vary from 0 to 60, the higher it is the higher the risk of depression. For a man, a threshold of 17 indicates a risk of depression and for a woman the same threshold is 23.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conjugal Support Questionnaire(CSQ)-Gambler
Outcome Measure for Gamblers
This questionnaire makes it possible to measure the quality of the support received and given perceived by the two members of the couple. It consists of a total of 8 questions, with a 5-point Likert scale (1 = never; 5 = always).
The total score shows support received and support gave, higher is the result, more it indicates that the member of the couple gave support and receives it (score min = 0 and score max=40).
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Marital Status Inventory (MSI)-Partner
Outcome Measure for Partners
The MSI is used to measure marital stability in a couple. It comprises a series of 14 items (with inverted items) in a "true" or "false" format thus aiming to assess the risk of separation in this couple (e.g., I very often have ideas of divorce, until once a week or more). Marital distress is measured in terms of concrete actions taken by members of the couple in order to end their union. The total score is between 0 and 14. The higher the scores, the higher the risk of separation and marital distress. A threshold of 8 is considered to be a severe indicator of separation.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Marital Status Inventory (MSI)-Gambler
Outcome Measure for Gamblers
The MSI is used to measure marital stability in a couple.
It comprises a series of 14 items (with inverted items) in a "true" or "false" format thus aiming to assess the risk of separation in this couple (e.g., I very often have ideas of divorce, until once a week or more). Marital distress is measured in terms of concrete actions taken by members of the couple in order to end their union. The total score is between 0 and 14. The higher the scores, the higher the risk of separation and marital distress. A threshold of 8 is considered to be a severe indicator of separation.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Dyadic Adjustment Scale (DAS-4)-Partner
Outcome Measure for Partners
The Dyadic Adjustment Scale is an ultra-brief measure degree of marital satisfaction within the couple.
The short version is made up of only 4 items (considered divorce, estimation of the quality of the relation, confide to mate, degree of happiness): three of which are on a 6-point Likert scale ranging from 0 (all the time) to 5 (never) , while the final item is on a 7-point scale ranging from 0 (extremely happy) to 6 (perfect).
Theoretically possible maximum score of 21, and minimum 0. Scores lower than 11 indicating relationship distress, scores between 12 and 14 corresponding to medium satisfaction and scores upper 15 indicating good marital satisfaction.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Dyadic Adjustment Scale (DAS-4)-Gambler
Outcome Measure for Gamblers
The Dyadic Adjustment Scale is an ultra-brief measure degree of marital satisfaction within the couple.
The short version is made up of only 4 items (considered divorce, estimation of the quality of the relation, confide to mate, degree of happiness): three of which are on a 6-point Likert scale ranging from 0 (all the time) to 5 (never) , while the final item is on a 7-point scale ranging from 0 (extremely happy) to 6 (perfect).
Theoretically possible maximum score of 21, and minimum 0. Scores lower than 11 indicating relationship distress, scores between 12 and 14 corresponding to medium satisfaction and scores upper 15 indicating good marital satisfaction.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conflict Tactics Scale-2_Psychological Violence Issued by the Partner
Outcome Measure for Gamblers
The psychological violence suffered is a subscale of the CTS-2 questionnaire which aims to assess the manifestations of psychological violence committed against the Gambler in the last 3 months. It is made up of 14 items that are rated on a 7-point Likert scale (never happened = 0, 1 time = 1, 2 times = 2, 3 to 5 times = 3, 6 to 10 times = 4, 11 to 20 = 5, more than 20 times = 6). To compute a total score, all item' score are summed. The total score ranges from 0 to 84. The higher it is, more it indicates that the respondent has suffered episodes of violence.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Interpersonal Communication Skills Inventory-self _Partner
Outcome Measure for Partners
This lists of skills consist of 17 items that expressed in statements representing observable verbal behaviors.Participants were asked to report frequency estimates of their own use of such verbal behaviors using a 4 point likert scale (0 = almost never, 4 = almost always). To compute a total score, all item' score are summed. The total score ranges from 0 to 68. The higher the score is, more it indicates the presence of good communication skills.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Marital Problem Solving Scale (MPSS)-Gambler
Outcome Measure for Gamblers
This instrument has 9 items, using a 7-point Likert-type scale. It is used in order to better understand the negotiation and conflict resolution skills that the couple members have used within their marital relationship in the last three months.
The score varies between 9 and 63. A high score indicates a greater degree of perceived problem-solving skill within the marital relationship.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Social Support Sub-scale_Gambler
Outcome Measure for Gamblers
This questionnaire is used to identify the coping strategies used to cope with gambling's habits in the last three months. The subscale is made up of 6 items marked from 0 to 3 (0 = not used; 3 = used a lot). To compute a total score, all item' score are summed. The total score ranges from 0 to 18. Higher the score is, more it indicates the respondent's tendency to adopt the behaviors described by the subscale when he is in a stressful situation.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Standard Units of Alcoholic Drinks Per Week _Gambler
Outcome measure for Gamblers
Number of alcohol standard units (Canada, 1 unit = 13,6g of alcohol) per week during the last three months.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Frequency of Cannabis Use Per week_Gambler
Outcome measure for Gamblers
Frequency of cannabis use per week in the last three months with a 5-point Likert-type scale (never = 0, 3 times a week or more = 4). Higher the score is, more it indicates a high frequency of cannabis use.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conflict Tactics Scale-2 _ Physical Violence Issued by the Partner
Outcome measure for Gamblers
The physical violence suffered is a subscale of the CTS-2 questionnaire which aims to assess the manifestations of physical violence committed against the Gambler in the last 3 months. It is made up of 18 items that are rated on a 7-point Likert scale (never happened = 0, 1 time = 1, 2 times = 2, 3 to 5 times = 3, 6 to 10 times = 4, 11 to 20 = 5, more than 20 times = 6). The total score corresponds to the average obtained on the 18 items, the higher it is, more it indicates that the respondent has suffered episodes of violence.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conflict Tactics Scale-2_ Physique Violence Issued by the Gambler
Outcome Measure for the Partner
The physical violence suffered is a subscale of the CTS-2 questionnaire which aims to assess the manifestations of physical violence committed against the partner in the last 3 months. It is made up of 18 items that are rated on a 7-point Likert scale (never happened = 0, 1 time = 1, 2 times = 2, 3 to 5 times = 3, 6 to 10 times = 4, 11 to 20 = 5, more than 20 times = 6). The total score corresponds to the average obtained on the 18 items, the higher it is, more it indicates that the respondent has suffered episodes of violence.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conflict Tactics Scale-2 _ Psychological Violence Issued by the Gambler
Outcome Measure for Partners
The psychological violence suffered is a subscale of the CTS-2 questionnaire which aims to assess the manifestations of psychological violence committed against the partner in the last 3 months. It is made up of 14 items that are rated on a 7-point Likert scale (never happened = 0, 1 time = 1, 2 times = 2, 3 to 5 times = 3, 6 to 10 times = 4, 11 to 20 = 5, more than 20 times = 6). To compute a total score, all item' score are summed. The total score ranges from 0 to 84. The higher it is, more it indicates that the respondent has suffered episodes of violence.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Positive Reevaluation/Problem Solving Sub-scale_Gambler
Outcome measure for Gamblers
This questionnaire is used to identify the coping strategies used to cope with gambling's habits in the last three months. The subscale is made up of 9 items marked from 0 to 3 (0 = not used; 3 = used a lot). To compute a total score, all item' score are summed. The total score ranges from 0 to 27. Higher the score is, more it indicates the respondent's tendency to adopt the behaviors described by the subscale when he is in a stressful situation.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Distancing / Withdrawal Sub-scale_Gambler
Outcome measure for Gamblers
This questionnaire is used to identify the coping strategies used to cope with gambling's habits in the last three months. The subscale is made up of 6 items marked from 0 to 3 (0 = not used; 3 = used a lot). To compute a total score, all item' score are summed. The total score ranges from 0 to 18.Higher the score is, more it indicates the respondent's tendency to adopt the behaviors described by the subscale when he is in a stressful situation.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Marital Problem Solving Scale (MPSS)-Partner
Outcome Measure for Partners This instrument has 9 items, using a 7-point Likert-type scale. It is used in order to better understand the negotiation and conflict resolution skills that the couple members have used within their marital relationship in the last three months.The score varies between 9 and 63. A high score indicates a greater degree of perceived problem-solving skill within the marital relationship.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Interpersonal Communication Skills Inventory-self _Gambler
Outcome Measure for Gamblers
This lists of skills consist of 17 items that expressed in statements representing observable verbal behaviors.Participants were asked to report frequency estimates of their own use of such verbal behaviors using a 4 point likert scale (0 = almost never, 4 = almost always). To compute a total score, all item' score are summed. The total score ranges from 0 to 68.The higher the score is, more it indicates the presence of good communication skills.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Social Support Sub-scale_Partner
Outcome Measure for Partners
This questionnaire is used to identify coping strategies to cope with stressful situations caused by their spouse's gambling habits in the last three months. The subscale is made up of 6 items marked from 0 to 3 (0 = not used; 3 = used a lot). To compute a total score, all item' score are summed. The total score ranges from 0 to 18.Higher the score is, more it indicates the respondent's tendency to adopt the behaviors described by the subscale when he is in a stressful situation.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Distancing / Withdrawal Sub-scale_Partner
Outcome Measure for Partners
This questionnaire is used to identify coping strategies to cope with stressful situations caused by their spouse's gambling habits in the last three months. The subscale is made up of 6 items marked from 0 to 3 (0 = not used; 3 = used a lot). To compute a total score, all item' score are summed. The total score ranges from 0 to 18.Higher the score is, more it indicates the respondent's tendency to adopt the behaviors described by the subscale when he is in a stressful situation.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills_Positive Reevaluation/Problem Solving Sub-scale_Partner
Outcome Measure for Partners
This questionnaire is used to identify coping strategies to cope with stressful situations caused by their spouse's gambling habits in the last three months. The subscale is made up of 9 items marked from 0 to 3 (0 = not used; 3 = used a lot). To compute a total score, all item' score are summed. The total score ranges from 0 to 27.Higher the score is, more it indicates the respondent's tendency to adopt the behaviors described by the subscale when he is in a stressful situation.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Standard Units of Alcoholic Drinks Per Week _Partner
Outcome measure for Partners
Number of alcohol standard units (Canada, 1 unit = 13,6g of alcohol) per week during the last three months.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Frequency of Cannabis Use Per week_Partner
Outcome measure for Partners
Frequency of cannabis use per week in the last three months with a 5-point Likert-type scale (never = 0, 3 times a week or more = 4). Higher the score is, more it indicates a high frequency of cannabis use.
Measured: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study start1 Mar 2011
- Primary completionDec 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joël Tremblay, Université du Québec à Trois-Rivières
- Investigators
- Joël Tremblay, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240485
- Sponsor's protocol ID
- CER-10-156-06.13
- Acronym
- ICT-PG
- Status last verified
- Mar 2022
- First submitted
- 4 Aug 2014
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tremblay J, Dufour M, Bertrand K, Saint-Jacques M, Ferland F, Blanchette-Martin N, Savard AC, Cote M, Berbiche D, Beaulieu M. Efficacy of a randomized controlled trial of integrative couple treatment for pathological gambling (ICT-PG): 10-month follow-up. J Consult Clin Psychol. 2023 Apr;91(4):221-233. doi: 10.1037/ccp0000765. Epub 2022 Dec 15.
PubMed 36521131
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Couple Treatment for Pathological Gambling or Individual Treatment: A Comparison of Efficacy
- ClinicalTrials.gov ID
- NCT02240485
- Acronym / sponsor ID
- ICT-PG / CER-10-156-06.13
- Conditions
- Pathological Gambling
- Keywords
- Pathological gambling, Treatment, Marital relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Posted 18 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare marital treatment to individual treatment for pathological gambling.
Detailed description
The study as two goals: evaluate the efficacy of couple treatment for pathological gambling and develop a better understanding of the individual (substance use, mental health) and couple dimensions (communication, marital satisfaction, violence) as intermediate variables explaining this efficacy. Couples will be randomized between the couple treatment and the treatment as usual (individual or group). The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Therapy for Pathological Gambling - ICT-PG) 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 behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support).
The control group receives individual or group treatment as already offered by the specialized centers in addiction. Their partner can receive individual intervention if desired. All participants are recruited in Specialized Addiction Treatment Centers in Quebec province, Canada. Evaluation of participants is done at admission, three, nine and 18 months post-admission.
Repeated measures ANOVA will be used to compared evolutions of groups over time. Multiple regression will allow the estimation of components roles into as intermediate variables to predict rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Couple Treatment for Pathological Gambling (ICT-PG) | Experimental | Behavioral: Integrative Couple Treatment for Pathological Gambling (ICT-PG)Couple therapy: The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Treatment for Pathological Gambling - ICT-PG) 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 behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support). |
| Usual individual/group treatment | Active comparator | Behavioral: Usual individual/group treatmentUsual individual/group treatment: The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Living together for at least 1 year
- Diagnosis of pathological gambling (WMH-CIDI) during the last 12 months
- The gambler has not received treatment for their gambling for at least 6 months (excluding GA)
- Presence of gambling behavior in the past 3 months
- Degree of commitment to the couple indicating a desire to continue the relationship (score of 7 - MSI)
Key exclusion criteria (7 listed)
- Alcohol/Drug Dependence gambler/partner (Severity of Alcohol Dependence Data questionnaire - SADD >17 included in DEBA-A; Severity of Dependence Scale - SDS > 5 Included in DEBA-D)
- Gambling problem for the partner (DEBA-Jeu > 10)
- Presence of serious acts of violence endangering the safety of both spouses (CTS-2)
- Disorder and serious mental health unstabilized one of two members of the couple (ASI: psychological scale)
- Antisocial personality disorder or severe limit ( GAIN: 9 + Scale BCS / CDS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Couple Treatment for Pathological Gambling (ICT-PG)Also: Couple therapyThe experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Therapy for Pathological Gambling - ICT-PG) 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 behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors incompatible with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support). | Behavioural | Integrative Couple Treatment for Pathological Gambling (ICT-PG) |
| Usual individual/group treatmentAlso: treatment as usualThe control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired. | Behavioural | Usual individual/group treatment |
Primary outcome
Gambling Symptom Assessment Scale (G-SAS)
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome measure for Gamblers The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each 12-item scale has a score ranging from 0 - 4 (adjective anchors for 0 and 4 vary for each item but "0 means no symptoms" and "4 means extreme symptoms"). All items ask for an average symptom based on the past 7 days (average urge, frequency, duration and control,thoughts associated with gambling,time spent on gambling,anticipatory tension and/or excitement, emotional distress). The total score ranges from 0 to 48. A score between 8 and 20 is an indicator of low urges to gamble, between 21 and 30, moderate urges, between 31 and 40 severe urges and a score of over 40 reveals the presence of extreme urges in the player.
Frequency of the Most Problematic Game
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome Measure for Gamblers Among 12 types of gambling activities, the highest frequency of gambling behaviors for the past 6 months (never = 0; every or almost every day=5). Maximum score is 5. The higher is the score, the higher is the frequency.
Detection of Gambling Problems and Services Need ("Détection et Besoin d'Aide en Regard du Jeu Excessif- DÉBA-Jeu")
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome Measure for Gamblers The DEBA-Jeu is a very brief screening grid comprising eight Likert-type items in five points (never = 0, always = 4). The eight items form a scale where the total score varies between 0 and 32. The suggested breaking points are as follows: 0 to 1 = No problem gambling; 2 to 5 =Problem gambling ; 6 to 24 = High probability of problem gambling.
Canadian Problem Gambling Index (CPGI)
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
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 an individual's gambling habits in the last three months 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.
Canadian Dollars Spent on Gambling
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome measure for Gamblers Total Money spent in canadian dollars for all gambling activities during the last 3 months previous each research interview.
Impaired Control Over Gambling Scale (ICOG)
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome Measure for Gamblers The ICOG is used to measure two aspects of control related to the JHA processes, namely the level of control over the desire to start playing (e.g., when I decide not to play, I watch stick to that decision) as well as the level of control once the game has started (e.g., when I knew I had little time to play, I would limit myself to the scheduled time). This questionnaire has a total of 10 items and uses a 5-point Likert-type scale ranging from "Never = 1" to "Always = 5", with 4 inverted items. The total score varies between 10 and 50. A high control represents a score between 10 and 16, a moderate control between 17 and 23 and a score of 24 and more presents a low control in the player.
Inventory of Erroneous Beliefs Related to Gambling ("Inventaire Des Croyances liées Aux Jeux" - ICROLJ)-Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome Measure for Gamblers This questionnaire measures people's beliefs about gambling. The ICROLJ has 29 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 116.Higher the score is, more it indicates the presence of erroneous beliefs.
Negative Gambling Consequences-Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome Measure for Gamblers Short questionnaire of 10 items, assessing to what extent the respondent considers his gambling habits in the last 6 months have harmed various aspects of his life (financial, living conditions, marital, physical health, professional life, social, legal and family). A 5-point Likert-type scale is used "Not at all = 0" to "Extremely = 4". To compute a total score, all item' score are summed. The total score ranges from 0 to 40.Higher the score is, more it's indicate that the respondent is experiencing negative impacts because of his gambling habits.
Negative Gambling Consequences-Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome Measure for Partners Short questionnaire of 10 items, assessing to what extent the respondent considers that his partner's gambling habits have harmed various aspects of his life in the last 6 months (financial, living conditions, marital, physical health, professional life, social, legal and family). A 5-point Likert-type scale is used "Not at all = 0" to "Extremely = 4". To compute a total score, all item' score are summed. The total score ranges from 0 to 40. Higher the score is, more it's indicate that the respondent is experiencing negative impacts because of his partner's gambling habits.
Inventory of Erroneous Beliefs Related to Gambling ("Inventaire Des Croyances liées Aux Jeux" - ICROLJ)-Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Outcome Measure for Partners This questionnaire measures people's beliefs about gambling. The ICROLJ has 29 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 116. Higher the score is, more it indicates the presence of erroneous beliefs.
28 secondary outcomes
Conjugal Support Questionnaire (CSQ)-Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Psychological Distress Index (IDPESQ-14)-Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Center for Epidemiologic Studies Depression Scale (CES-D)-Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Psychological Distress Index (IDPESQ-14)-Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Center for Epidemiologic Studies Depression Scale (CES-D)-Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conjugal Support Questionnaire(CSQ)-Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Marital Status Inventory (MSI)-Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Marital Status Inventory (MSI)-Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Dyadic Adjustment Scale (DAS-4)-Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Dyadic Adjustment Scale (DAS-4)-Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conflict Tactics Scale-2_Psychological Violence Issued by the Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Interpersonal Communication Skills Inventory-self _Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Marital Problem Solving Scale (MPSS)-Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Social Support Sub-scale_Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Standard Units of Alcoholic Drinks Per Week _Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Frequency of Cannabis Use Per week_Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conflict Tactics Scale-2 _ Physical Violence Issued by the Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conflict Tactics Scale-2_ Physique Violence Issued by the Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Conflict Tactics Scale-2 _ Psychological Violence Issued by the Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Positive Reevaluation/Problem Solving Sub-scale_Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Distancing / Withdrawal Sub-scale_Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Marital Problem Solving Scale (MPSS)-Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Interpersonal Communication Skills Inventory-self _Gambler
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Social Support Sub-scale_Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills _Distancing / Withdrawal Sub-scale_Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Coping Skills_Positive Reevaluation/Problem Solving Sub-scale_Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Standard Units of Alcoholic Drinks Per Week _Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Frequency of Cannabis Use Per week_Partner
Time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36521131Tremblay J, Dufour M, Bertrand K, Saint-Jacques M, Ferland F, Blanchette-Martin N, Savard AC, Cote M, Berbiche D, Beaulieu M. Efficacy of a randomized controlled trial of integrative couple treatment for pathological gambling (ICT-PG): 10-month follow-up. J Consult Clin Psychol. 2023 Apr;91(4):221-233. doi: 10.1037/ccp0000765. Epub 2022 Dec 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joël Tremblay principal investigator
Université du Québec à Trois-Rivières
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Couple Treatment for Pathological Gambling (ICT-PG) and Usual individual/group treatment in people with Pathological Gambling, run by Université du Québec à Trois-Rivières at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gambling Symptom Assessment Scale (G-SAS) (time frame: Admission, 3, 9 and 18 month post-admission (The first admission was March 2011 and the last admission will be June 2016)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.