Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders

Alcohol Dependence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141789
• Other study ID #: UKonstanzMOdenwald2014-1
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 2018

Study information

• Verified date: March 2020
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• alcohol dependence

• comorbid anxiety or mood disorder

Exclusion Criteria:

• severe mental illness: psychosis, mania, personality disorders

• current suicidality

• non-compliance with appointments during first 5 sessions

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Outpatient Cognitive Behavioral Psychotherapy
Integrated CBT intervention for alcohol dependence and comorbid psychiatric disorder (we include only patients with comorbid mood or anxiety disorders).
• Outpatient Cognitive Behavioral Psychotherapy
The intervention is a well established form of psychotherapy that has infrequently been used in the German system with this group of patients in contrast to many other countries where it is the standard approach, e.g. the US.

Locations

Country	Name	City	State
Germany	University of Konstanz, Outpatient Clinic for Psychotherapy	Konstanz

Sponsors (1)

Lead Sponsor	Collaborator
University of Konstanz

Country where clinical trial is conducted

Germany, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse	We assess whether participants have an alcohol relapse (any drinking of alcohol) in the three months after study inclusion	3 months
Primary	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	Comorbid psychiatric symptoms	Anxiety, depression and other relevant psychiatric symptoms will be measured by different standardized questionnaires at t1 (before treatment) and after 3 months (t2). We will use standardized symptom change as outcome measure.	3 months