Alcohol DependencePhase 2MEADOW/BridgeNCT00851669
The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health)
A Phase 2 study testing Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) and Treatment as Usual in people with Alcohol Dependence and Depression, run by University of Rochester at 1 site in United States.
Trial summary
The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol has been added to pilot the current study with men with co-occurring alcohol dependence and depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence, Depression
- What is being tested?
- Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2013
- 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
- Current Alcohol Dependence and Major Depression
Who cannot join
- Bipolar Disorder
- Psychosis or schizophrenia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Behavioral Treatment for Alcohol Dependent Women With Co-occurring Depression
The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol has been added to pilot the current study with men with co-occurring alcohol dependence and depression.
Read the detailed description
Co-occurring alcohol dependence and major depression (AD-MD) is a serious and common public health problem, yet one that is largely unaddressed by conventional chemical dependency treatment. Among alcohol dependent patients, co-occurring depression is associated with poorer treatment outcomes, increased risk for relapse, worse long-term social and functional adjustment, and higher probability of dire outcomes such as suicide. Treatment research on AD-MD patients is needed to inform effective practice. This study provides an initial test of the applicability of Interpersonal Psychotherapy for alcohol dependent women with major depression (IPT-ADMD). The goal of the proposed research project is to refine and test a behavioral intervention that addresses women's co-occurring alcohol dependence and depression within a cohesive interpersonal frame. In Phase 1 of the project, IPT-ADMD will be piloted with 15 AD-MD women enrolled in a MICA (mentally-ill chemical abusers) group treatment program. Findings from Phase 1 will be used to refine the treatment, assessment, and therapist training procedures. In Phase 2, a randomized controlled trial with 60 AD-MD women will be conducted 1) to determine IPT-ADMD's feasibility and acceptability as an adjunct to standard MICA group treatment, and 2) to assess the comparative effects of IPT-ADMD to treatment-as-usual individual therapy (TAU-IT). Compared to TAU-IT, IPT-ADMD is hypothesized to lead to greater reductions in women's drinking frequency, drinking intensity, and depressive symptoms, and to improved interpersonal functioning.
In addition to the current intervention study comparing IPT-ADMD with TAU-IT, we are piloting IPT-ADMD with men in a sub-protocol of the main study. The target population of the Bridge Program will be men with alcohol dependence and co-occurring major depression. We hypothesize that IPT will be feasible and acceptable and will improve drinking frequency and intensity; depressive symptoms; and interpersonal functioning. The proposed sub-protocol will allow us to determine if future clinical trials of IPT should include both male and female patients with co-occurring alcohol dependence and depression.
- Conditions
- Alcohol Dependence, Depression
- Being tested
- Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD), Treatment as Usual
- Keywords
- depression, alcohol dependence, women, psychotherapy, men
- Medical subject headings
- Alcoholism, Depression, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD)Behavioural
Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of patients with co-occurring alcohol dependence and major depression
Treatment as UsualBehavioural
Individual psychotherapy following usual care practice in a chemical dependency treatment program.
| Study group | Role | What they receive |
|---|---|---|
| IPT | Experimental | Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of patients with co-occurring alcohol dependence and major depression Receives: Behavioral: Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) |
| Treatment as Usual | Active comparator | Individual psychotherapy following usual care practice in a chemical dependency treatment program. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day)
Measured: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men
Secondary outcomes (2)
Beck Depression Inventory
Measured: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men
Hamilton Rating Scale for Depression
Measured: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Stephanie Gamble, University of Rochester
- Investigators
- Stephanie A Gamble, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851669
- Sponsor's protocol ID
- RSRB00023495
- Other IDs
- NIH Grant 1K23AA017246-01A1
- Acronym
- MEADOW/Bridge
- Status last verified
- Jul 2013
- First submitted
- 25 Feb 2009
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment for Alcohol Dependent Women With Co-occurring Depression
- ClinicalTrials.gov ID
- NCT00851669
- Acronym / sponsor ID
- MEADOW/Bridge / RSRB00023495
- Conditions
- Alcohol Dependence, Depression
- Keywords
- depression, alcohol dependence, women, psychotherapy, men
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Feb 2009 (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.
The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol has been added to pilot the current study with men with co-occurring alcohol dependence and depression.
Detailed description
Co-occurring alcohol dependence and major depression (AD-MD) is a serious and common public health problem, yet one that is largely unaddressed by conventional chemical dependency treatment. Among alcohol dependent patients, co-occurring depression is associated with poorer treatment outcomes, increased risk for relapse, worse long-term social and functional adjustment, and higher probability of dire outcomes such as suicide. Treatment research on AD-MD patients is needed to inform effective practice. This study provides an initial test of the applicability of Interpersonal Psychotherapy for alcohol dependent women with major depression (IPT-ADMD). The goal of the proposed research project is to refine and test a behavioral intervention that addresses women's co-occurring alcohol dependence and depression within a cohesive interpersonal frame. In Phase 1 of the project, IPT-ADMD will be piloted with 15 AD-MD women enrolled in a MICA (mentally-ill chemical abusers) group treatment program. Findings from Phase 1 will be used to refine the treatment, assessment, and therapist training procedures. In Phase 2, a randomized controlled trial with 60 AD-MD women will be conducted 1) to determine IPT-ADMD's feasibility and acceptability as an adjunct to standard MICA group treatment, and 2) to assess the comparative effects of IPT-ADMD to treatment-as-usual individual therapy (TAU-IT). Compared to TAU-IT, IPT-ADMD is hypothesized to lead to greater reductions in women's drinking frequency, drinking intensity, and depressive symptoms, and to improved interpersonal functioning.
In addition to the current intervention study comparing IPT-ADMD with TAU-IT, we are piloting IPT-ADMD with men in a sub-protocol of the main study. The target population of the Bridge Program will be men with alcohol dependence and co-occurring major depression. We hypothesize that IPT will be feasible and acceptable and will improve drinking frequency and intensity; depressive symptoms; and interpersonal functioning. The proposed sub-protocol will allow us to determine if future clinical trials of IPT should include both male and female patients with co-occurring alcohol dependence and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPT | Experimental | Behavioral: Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD)Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of patients with co-occurring alcohol dependence and major depression |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualIndividual psychotherapy following usual care practice in a chemical dependency treatment program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current Alcohol Dependence and Major Depression
Key exclusion criteria (2 listed)
- Bipolar Disorder
- Psychosis or schizophrenia
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 |
|---|---|---|
| Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD)Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of patients with co-occurring alcohol dependence and major depression | Behavioural | IPT |
| Treatment as UsualIndividual psychotherapy following usual care practice in a chemical dependency treatment program. | Behavioural | Treatment as Usual |
Primary outcome
Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day)
Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men
2 secondary outcomes
Beck Depression Inventory
Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men
Hamilton Rating Scale for Depression
Time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men
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 16 Jul 2013.
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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.
Stephanie A Gamble, Ph.D. principal investigator
University of Rochester
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 Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) and Treatment as Usual in people with Alcohol Dependence and Depression, run by University of Rochester 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 2 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 16 Jul 2013. 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?
Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day) (time frame: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men). 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 16 Jul 2013.