NCT01689103

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

9.7 years

First QC Date

September 17, 2012

Last Update Submit

April 26, 2022

Conditions

Alcohol Use Disorders

Keywords

Alcohol use disordersTreatmentOutpatientTherapeutic alliance

Outcome Measures

Primary Outcomes (1)

  • Percent days abstinent

    12 months

Secondary Outcomes (1)

  • Drinks per Drinking Day

    12 months

Study Arms (2)

Alliance Feedback to Therapist

EXPERIMENTAL

Alliance feedback provided to therapist

Behavioral: Cognitive-behavioral treatment

No alliance feedback to therapist

PLACEBO COMPARATOR

No alliance feedback provided to therapist

Behavioral: Cognitive-behavioral treatment

Interventions

Cognitive-behavioral treatmentBEHAVIORAL

Cognitive-behavioral treatment of alcohol use disorders

Alliance Feedback to TherapistNo alliance feedback to therapist

Eligibility Criteria

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

You may qualify if:

  • Current Alcohol Dependence diagnosis
  • Live within commuting distance of treatment program
  • Minimum 6th grade reading level
  • Provide consent

You may not qualify if:

  • Presence of current organic mental disorder, schizophrenia, or another psychotic disorder
  • Treatment for an alcohol use disorder in past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute on Addictions

Buffalo, New York, 14203, United States

Location

Related Publications (1)

  • 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.

    PMID: 36863860DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Gerard J Connors, Ph.D.

    University at Buffalo

    PRINCIPAL INVESTIGATOR

  • Stephen A Maisto, PhD

    Syracuse University

    PRINCIPAL INVESTIGATOR

  • Ronda L Dearing, PhD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2022

Study Completion

April 26, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations

US(1)