NCT02141789

Brief Summary

Research has shown that alcohol dependence often co-occurs with comorbid anxiety disorders and/or depression. Anxiety and depression influence the course and treatment of alcohol dependence and are a major risk factor for alcohol relapse within the first three months after detoxification. Therefore, there is need for combined treatment (integrated therapy) of alcohol dependence and comorbid psychiatric disorders, e.g. anxiety and/or depression. Until today, there are no systematic outpatient treatment offers for this special group of patients in Germany. In this study we want to investigate if integrated outpatient cognitive behavioral therapy can prevent and decrease alcohol relapse within the first three months after detoxification. Therefore we hypothesize that immediate start of integrated outpatient psychotherapy will reduce relapse variables compared to treatment as usual which is characterized by non-immediate start of therapy due to the required application for insurance coverage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3.1 years

First QC Date

May 15, 2014

Last Update Submit

March 23, 2020

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (2)

  • Relapse

    We assess whether participants have an alcohol relapse (any drinking of alcohol) in the three months after study inclusion

    3 months

  • Days with heavy alcohol drinking

    We assess with the Timeline Follow Back (TLFB, Sobell \& Sobell, 2000) the number of days with heavy alcohol drinking (for a man 5 or more drinks a day, for a woman 4 or more drinks a day) in the three months after study inclusion

    3 months

Secondary Outcomes (1)

  • Comorbid psychiatric symptoms

    3 months

Study Arms (1)

Outpatient Cognitive Behavioral Psychotherapy

EXPERIMENTAL

Outpatient Cognitive Behavioral Therapy is a well-known and frequently applied psychotherapy approach that does not need further description.

Behavioral: Outpatient Cognitive Behavioral Psychotherapy

Interventions

Outpatient Cognitive Behavioral PsychotherapyBEHAVIORAL

Integrated CBT intervention for alcohol dependence and comorbid psychiatric disorder (we include only patients with comorbid mood or anxiety disorders).

Outpatient Cognitive Behavioral Psychotherapy

Eligibility Criteria

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

You may qualify if:

  • alcohol dependence
  • comorbid anxiety or mood disorder

You may not qualify if:

  • severe mental illness: psychosis, mania, personality disorders
  • current suicidality
  • non-compliance with appointments during first 5 sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz, Outpatient Clinic for Psychotherapy

Konstanz, 78464, Germany

Location

Related Publications (1)

  • Schawohl A, Adam M, Odenwald M. What's Next After Withdrawal Treatment? A Randomized Controlled Pilot Study on Integrated Outpatient Psychotherapy in Alcohol-Dependent Patients With Dual Diagnoses. Zeitschrift für Klinische Psychologie und Psychotherapie. 2018; 47(3): 153-162. doi: 10.1026/1616-3443/a000487

    RESULT

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Michael Odenwald, Dr. rer. nat.

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. rer. nat., Dipl. Psych., Licensed Psychotherapist

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 19, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

DE(1)