AlcoholismPhase 2CALMNCT01659957
Couples Therapy for Alcoholic Patients
A Phase 2 study testing Group Couples Counseling and One-on-One Couples Counseling in people with Alcoholism, run by Harvard University at 1 site in United States.
Trial summary
In treating alcoholism, many studies show Behavioral Couples Therapy (BCT) is more effective than typical counseling, but BCT is not widely used because standard BCT delivered one couple at a time is costly to deliver and does not fit with the primary group therapy focus of most community clinics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Group Couples Counseling and One-on-One Couples Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both members of the couple must be between 18 and 65 years of age; (b) patient must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria for current (past 12 months) alcohol dependence and alcohol must be the patient's primary substance of abuse as determined by a clinical algorithm (Fals-Stewart, Stappenbeck et al, 2004); (c) be married to their current partner for at least 1 year or be cohabiting in a stable common-law relationship for 2 years; (d) patient agrees to a goal of abstinence from alcohol and drugs at least for the duration of the 12-week study-based treatment; (e) patient drank in past 60 days; (f) patient agrees to forego other alcoholism counseling except for self-help meetings (e.g., AA) or treatment required for a clinical emergency or clinical deterioration for the duration of the 12-week study-based treatment; (g) no more than 4 months living apart in past year; (h) alcohol dependent patient and partner currently living with each other, i.e., not separated or planning divorce; and (i) both alcohol dependent patient and the relationship partner are willing to participate.
Who cannot join
- partner meets DSM-IV criteria for a substance use disorder (other than nicotine) in the last 12 months; (b) patient has dependence on alcohol or other drugs that requires inpatient treatment or medical detoxification (as indicated by daily heavy use or use to prevent or deal with withdrawal symptoms) - after patient has completed detoxification, he or she may be eligible for the study; (c) patient or partner are at immediate risk for suicide or homicide or either made a suicide attempt in past 30 days; and (d) patient or partner meets DSM-IV criteria for a current organic mental disorder, schizophrenia, delusional (paranoid) disorder, or any of the other psychotic disorders. The SCID-IV (SCID; First, Spitzer, Gibbon, \& Williams, 1995) will be used to screen out participants with psychosis or thought disorder. Subjects with other disorders, however, will not be excluded. Consistent with general AdCare Hospital services, the AdCare physician can prescribe psychiatric medication (e.g., antidepressants) if necessary. Finally, we also will exclude couples with a recent history (past 3 years) of severe partner violence on a day when drinking or drug use did not occur or if either member of the couple expresses fear that couples therapy may put him or her at risk of violence.
Trial locations and contacts
1 site in 1 country.
United States1 site
AdCare Hospital of Worcester, Inc.
Worcester, Massachusetts, 01605
About this study
Official title: Behavioral Couples Group Therapy for Alcholic Patients: Clinical and Cost Outcomes
In treating alcoholism, many studies show Behavioral Couples Therapy (BCT) is more effective than typical counseling, but BCT is not widely used because standard BCT delivered one couple at a time is costly to deliver and does not fit with the primary group therapy focus of most community clinics. The proposed study will test with married or cohabiting alcoholic patients whether a group format for BCT will produce similar positive outcomes as standard BCT, and deliver these results at a lower cost. If outcomes are favorable, this could prompt clinics to start using group BCT and improve outcomes for alcoholic patients and their families.
Read the detailed description
Multiple studies indicate that participation in Behavioral Couples Therapy (BCT) is associated with robust positive outcomes for alcoholic and drug-abusing patients, in terms of reduced substance use and improved relationship functioning. Yet, community-based treatment programs rarely offer BCT to incoming eligible patients. As reported by providers and administrators in a national survey of treatment programs in the U.S., BCT was viewed as prohibitively labor intensive, due in large measure to its standard conjoint one-couple-at-a-time delivery format. Given the public policy climate that is now emphasizing not only clinical effectiveness, but also economic accountability, an intervention's efficiency (i.e., the ratio of effectiveness to program resources used to provide the service) is a critical factor in decisions by treatment programs to adopt new interventions. Although BCT has well-proven efficacy, the consensus of providers and administrators is that BCT is not efficient.
To address these issues, we have studied couples group formats to deliver BCT. First, in earlier work the PI developed a 10-week BCT group with a number of conjoint sessions added before to prepare couples and afterwards to prevent relapse. While the outcomes were favorable, the added conjoint sessions and the closed group that once begun did not add additional members made it a hard sell for community agencies looking for briefer treatments and typically running ongoing groups with new members added regularly. Second, to overcome these problems, the PI and Co-PI developed a 10-session ongoing BCT group format that has rotating content and rolling admissions in which couples join the group, complete 10 sessions, and "graduate". A major advantage of this ongoing group format for BCT is that it fits with the way other types of groups generally are run in substance abuse programs. It got favorable reviews in provider focus groups and showed promise in a pilot study.
The pilot study with married or cohabiting male drug-abusing patients examined the efficacy of a multi-couple group therapy version of BCT (G-BCT) compared to standard conjoint BCT (S-BCT), and individual-based treatment (group and individual counseling) for the patient only. Results showed G-BCT yielded equivalent outcomes when compared to S-BCT, in terms of reduction in substance use and improved relationship adjustment, but GBCT was less costly to deliver and had superior cost-benefit and cost-effectiveness. Both G-BCT and S-BCT yielded better clinical and cost-outcomes than individual-based treatment. Also, a small-scale evaluation study indicated G-BCT was more likely to be used in community-based treatment programs than S-BCT.
Thus, this proposed study will conduct a randomized clinical trial to examine the clinical effectiveness, in terms of substance use, relationship functioning, and psychosocial adjustment, of Group BCT (G-BCT) versus Standard BCT (S-BCT) for 160 alcoholic patients and their nonsubtance-abusing partners. Given the likely differences in cost of treatment delivery between the 2 interventions, we will also examine the comparative cost-benefit and cost-effectiveness of the 2 intervention packages.
- Conditions
- Alcoholism
- Being tested
- Group Couples Counseling, One-on-One Couples Counseling
- Keywords
- Alcoholism, Couples
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Couples CounselingBehavioural
One-on-One Couples CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group Couples Couseling | Experimental | Patients randomized to this arm will receive group couples counseling plus 12-step oriented alcoholism counseling. Receives: Behavioral: Group Couples Counseling |
| One-on-One Couples Couseling | Experimental | Patients randomized to this arm will receive one-on-one couples counseling plus 12-step oriented alcoholism counseling. Receives: Behavioral: One-on-One Couples Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days abstinent from alcohol or illicit drugs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startNov 2010
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy J. O'Farrell, Harvard University
- Investigators
- Timothy J O'Farrell, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659957
- Sponsor's protocol ID
- R01AA017865
- Acronym
- CALM
- Status last verified
- Mar 2015
- First submitted
- 6 Aug 2012
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Couples Group Therapy for Alcholic Patients: Clinical and Cost Outcomes
- ClinicalTrials.gov ID
- NCT01659957
- Acronym / sponsor ID
- CALM / R01AA017865
- Conditions
- Alcoholism
- Keywords
- Alcoholism, Couples
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In treating alcoholism, many studies show Behavioral Couples Therapy (BCT) is more effective than typical counseling, but BCT is not widely used because standard BCT delivered one couple at a time is costly to deliver and does not fit with the primary group therapy focus of most community clinics. The proposed study will test with married or cohabiting alcoholic patients whether a group format for BCT will produce similar positive outcomes as standard BCT, and deliver these results at a lower cost. If outcomes are favorable, this could prompt clinics to start using group BCT and improve outcomes for alcoholic patients and their families.
Detailed description
Multiple studies indicate that participation in Behavioral Couples Therapy (BCT) is associated with robust positive outcomes for alcoholic and drug-abusing patients, in terms of reduced substance use and improved relationship functioning. Yet, community-based treatment programs rarely offer BCT to incoming eligible patients. As reported by providers and administrators in a national survey of treatment programs in the U.S., BCT was viewed as prohibitively labor intensive, due in large measure to its standard conjoint one-couple-at-a-time delivery format. Given the public policy climate that is now emphasizing not only clinical effectiveness, but also economic accountability, an intervention's efficiency (i.e., the ratio of effectiveness to program resources used to provide the service) is a critical factor in decisions by treatment programs to adopt new interventions. Although BCT has well-proven efficacy, the consensus of providers and administrators is that BCT is not efficient.
To address these issues, we have studied couples group formats to deliver BCT. First, in earlier work the PI developed a 10-week BCT group with a number of conjoint sessions added before to prepare couples and afterwards to prevent relapse. While the outcomes were favorable, the added conjoint sessions and the closed group that once begun did not add additional members made it a hard sell for community agencies looking for briefer treatments and typically running ongoing groups with new members added regularly. Second, to overcome these problems, the PI and Co-PI developed a 10-session ongoing BCT group format that has rotating content and rolling admissions in which couples join the group, complete 10 sessions, and "graduate". A major advantage of this ongoing group format for BCT is that it fits with the way other types of groups generally are run in substance abuse programs. It got favorable reviews in provider focus groups and showed promise in a pilot study.
The pilot study with married or cohabiting male drug-abusing patients examined the efficacy of a multi-couple group therapy version of BCT (G-BCT) compared to standard conjoint BCT (S-BCT), and individual-based treatment (group and individual counseling) for the patient only. Results showed G-BCT yielded equivalent outcomes when compared to S-BCT, in terms of reduction in substance use and improved relationship adjustment, but GBCT was less costly to deliver and had superior cost-benefit and cost-effectiveness. Both G-BCT and S-BCT yielded better clinical and cost-outcomes than individual-based treatment. Also, a small-scale evaluation study indicated G-BCT was more likely to be used in community-based treatment programs than S-BCT.
Thus, this proposed study will conduct a randomized clinical trial to examine the clinical effectiveness, in terms of substance use, relationship functioning, and psychosocial adjustment, of Group BCT (G-BCT) versus Standard BCT (S-BCT) for 160 alcoholic patients and their nonsubtance-abusing partners. Given the likely differences in cost of treatment delivery between the 2 interventions, we will also examine the comparative cost-benefit and cost-effectiveness of the 2 intervention packages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Couples Couseling | Experimental | Behavioral: Group Couples CounselingPatients randomized to this arm will receive group couples counseling plus 12-step oriented alcoholism counseling. |
| One-on-One Couples Couseling | Experimental | Behavioral: One-on-One Couples CounselingPatients randomized to this arm will receive one-on-one couples counseling plus 12-step oriented alcoholism counseling. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- both members of the couple must be between 18 and 65 years of age; (b) patient must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria for current (past 12 months) alcohol dependence and alcohol must be the patient's primary substance of abuse as determined by a clinical algorithm (Fals-Stewart, Stappenbeck et al, 2004); (c) be married to their current partner for at least 1 year or be cohabiting in a stable common-law relationship for 2 years; (d) patient agrees to a goal of abstinence from alcohol and drugs at least for the duration of the 12-week study-based treatment; (e) patient drank in past 60 days; (f) patient agrees to forego other alcoholism counseling except for self-help meetings (e.g., AA) or treatment required for a clinical emergency or clinical deterioration for the duration of the 12-week study-based treatment; (g) no more than 4 months living apart in past year; (h) alcohol dependent patient and partner currently living with each other, i.e., not separated or planning divorce; and (i) both alcohol dependent patient and the relationship partner are willing to participate.
Key exclusion criteria (1 listed)
- partner meets DSM-IV criteria for a substance use disorder (other than nicotine) in the last 12 months; (b) patient has dependence on alcohol or other drugs that requires inpatient treatment or medical detoxification (as indicated by daily heavy use or use to prevent or deal with withdrawal symptoms) - after patient has completed detoxification, he or she may be eligible for the study; (c) patient or partner are at immediate risk for suicide or homicide or either made a suicide attempt in past 30 days; and (d) patient or partner meets DSM-IV criteria for a current organic mental disorder, schizophrenia, delusional (paranoid) disorder, or any of the other psychotic disorders. The SCID-IV (SCID; First, Spitzer, Gibbon, \& Williams, 1995) will be used to screen out participants with psychosis or thought disorder. Subjects with other disorders, however, will not be excluded. Consistent with general AdCare Hospital services, the AdCare physician can prescribe psychiatric medication (e.g., antidepressants) if necessary. Finally, we also will exclude couples with a recent history (past 3 years) of severe partner violence on a day when drinking or drug use did not occur or if either member of the couple expresses fear that couples therapy may put him or her at risk of violence.
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 |
|---|---|---|
| Group Couples Counseling | Behavioural | Group Couples Couseling |
| One-on-One Couples Counseling | Behavioural | One-on-One Couples Couseling |
Primary outcome
Percent days abstinent from alcohol or illicit drugs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
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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.
Timothy J O'Farrell, PhD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group Couples Counseling and One-on-One Couples Counseling in people with Alcoholism, run by Harvard University at 1 site in United States.
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 1 inclusion and 1 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 23 Mar 2015. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent days abstinent from alcohol or illicit drugs (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2015.