NCT00851669

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

4.3 years

First QC Date

February 25, 2009

Last Update Submit

July 12, 2013

Conditions

Keywords

depressionalcohol dependencewomenpsychotherapymen

Outcome Measures

Primary Outcomes (1)

  • Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day)

    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

    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

    Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men

Study Arms (2)

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

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.

Behavioral: Treatment as Usual

Interventions

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

IPT

Individual psychotherapy following usual care practice in a chemical dependency treatment program.

Treatment as Usual

Eligibility Criteria

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

You may qualify if:

  • Current Alcohol Dependence and Major Depression

You may not qualify if:

  • Bipolar Disorder
  • Psychosis or schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

AlcoholismDepressionMultiple Endocrine Neoplasia Type 1

Interventions

Interpersonal PsychotherapyEthanolTherapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehaviorMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesAlcoholsOrganic Chemicals

Study Officials

  • Stephanie A Gamble, Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Department of Psychiatry

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations