Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders

Study Overview
=================
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.

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Behavioral: Outpatient Cognitive Behavioral Psychotherapy
* Behavioral: Outpatient Cognitive Behavioral Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient Cognitive Behavioral Psychotherapy<br>Outpatient Cognitive Behavioral Therapy is a well-known and frequently applied psychotherapy approach that does not need further description. | Behavioral: Outpatient Cognitive Behavioral Psychotherapy<br>* Integrated CBT intervention for alcohol dependence and comorbid psychiatric disorder (we include only patients with comorbid mood or anxiety disorders).<br>Behavioral: Outpatient Cognitive Behavioral Psychotherapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |