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Completed

NCT Number: NCT02141789

Outpatient Psychotherapeutic Treatment for Alcohol Dependent Individuals With Comorbid Psychiatric Disorders

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Konstanz, Outpatient Clinic for Psychotherapy

Konstanz, 78464, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outpatient Cognitive Behavioral Psychotherapy

Behavioral

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

Primary outcomes

  1. Relapse

    Time frame: 3 months

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

  2. Days with heavy alcohol drinking

    Time frame: 3 months

    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

Secondary outcomes

  1. Comorbid psychiatric symptoms

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Konstanz

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 19, 2014
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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