Alcohol Use DisordersNCT01689103
Therapeutic Alliances in Alcoholism Treatment
A study testing Cognitive-behavioral treatment in people with Alcohol Use Disorders, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorders
- What is being tested?
- Cognitive-behavioral treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 26 Apr 2022
- Phase
- Interventional
- 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 diagnosis
- Live within commuting distance of treatment program
- Minimum 6th grade reading level
- Provide consent
Who cannot join
- Presence of current organic mental disorder, schizophrenia, or another psychotic disorder
- Treatment for an alcohol use disorder in past 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Institute on Addictions
Buffalo, New York, 14203
About this study
This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders.
Read the detailed description
This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders. Alliances are assessed over the course of treatment and will be reviewed in the context of posttreatment functioning.
- Conditions
- Alcohol Use Disorders
- Being tested
- Cognitive-behavioral treatment
- Keywords
- Alcohol use disorders, Treatment, Outpatient, Therapeutic alliance
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral treatmentBehavioural
Cognitive-behavioral treatment of alcohol use disorders
Cognitive-behavioral treatmentBehavioural
Cognitive-behavioral treatment for alcohol use disorders
| Study group | Role | What they receive |
|---|---|---|
| Alliance Feedback to Therapist | Experimental | Alliance feedback provided to therapist Receives: Behavioral: Cognitive-behavioral treatment |
| No alliance feedback to therapist | Placebo comparator | No alliance feedback provided to therapist Receives: Behavioral: Cognitive-behavioral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days abstinent
Measured: 12 months
Secondary outcomes (1)
Drinks per Drinking Day
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 posted20 Sep 2012 (estimated)
- Study startAug 2012
- Primary completion1 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerard J. Connors, State University of New York at Buffalo
- Investigators
- Gerard J Connors, Ph.D., Principal investigator, University at BuffaloStephen A Maisto, PhD, Principal investigator, Syracuse UniversityRonda L Dearing, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689103
- Sponsor's protocol ID
- 1R01AA020253
- Status last verified
- Apr 2022
- First submitted
- 17 Sep 2012
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rivera AP, Maisto SA, Connors GJ, Schlauch RC. Therapists' first impression of treatment motivation moderates the relationship between the client-rated therapeutic alliance and drinking outcomes during treatment. Alcohol Clin Exp Res (Hoboken). 2023 Apr;47(4):806-821. doi: 10.1111/acer.15040. Epub 2023 Mar 2.
PubMed 36863860
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Alliances in Alcoholism Treatment
- ClinicalTrials.gov ID
- NCT01689103
- Acronym / sponsor ID
- 1R01AA020253
- Conditions
- Alcohol Use Disorders
- Keywords
- Alcohol use disorders, Treatment, Outpatient, Therapeutic alliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 20 Sep 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.
This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders.
Detailed description
This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders. Alliances are assessed over the course of treatment and will be reviewed in the context of posttreatment functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alliance Feedback to Therapist | Experimental | Behavioral: Cognitive-behavioral treatmentAlliance feedback provided to therapist |
| No alliance feedback to therapist | Placebo comparator | Behavioral: Cognitive-behavioral treatmentNo alliance feedback provided to therapist |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current Alcohol Dependence diagnosis
- Live within commuting distance of treatment program
- Minimum 6th grade reading level
- Provide consent
Key exclusion criteria (2 listed)
- Presence of current organic mental disorder, schizophrenia, or another psychotic disorder
- Treatment for an alcohol use disorder in past 12 months
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 |
|---|---|---|
| Cognitive-behavioral treatmentCognitive-behavioral treatment of alcohol use disorders | Behavioural | Alliance Feedback to Therapist, No alliance feedback to therapist |
| Cognitive-behavioral treatmentCognitive-behavioral treatment for alcohol use disorders | Behavioural | Alliance Feedback to Therapist, No alliance feedback to therapist |
Primary outcome
Percent days abstinent
Time frame: 12 months
1 secondary outcome
Drinks per Drinking Day
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 27 Apr 2022.
- Derived from this study: PubMed 36863860Rivera AP, Maisto SA, Connors GJ, Schlauch RC. Therapists' first impression of treatment motivation moderates the relationship between the client-rated therapeutic alliance and drinking outcomes during treatment. Alcohol Clin Exp Res (Hoboken). 2023 Apr;47(4):806-821. doi: 10.1111/acer.15040. Epub 2023 Mar 2.
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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.
Gerard J Connors, Ph.D. principal investigator
University at Buffalo
Stephen A Maisto, PhD principal investigator
Syracuse University
Ronda L Dearing, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral treatment in people with Alcohol Use Disorders, run by State University of New York at Buffalo 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 4 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 27 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 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. Some participants in this study may receive a placebo. 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?
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 (time frame: 12 months). 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 NCT01689103, 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 27 Apr 2022.