A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity

NCT01941693 | Completed

• 1 other identifier: X05-0279
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

There is a high rate of psychological comorbidity in people suffering from alcohol dependence. There is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety or depression. This study will test the efficacy of a novel integrated intervention for comorbid alcohol dependence and anxiety or mood disorder.

Conditions

Alcohol Dependence; Anxiety; Depression

Keywords

alcohol; anxiety; depression; comorbidity; CBT

Outcome Measures

Primary Outcomes (3)

• Alcohol consumption

  Time to relapse (\>5 drinks on any one day)

  12 weeks

• Time to lapse

  time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption

  12 weeks

• amount of alcohol consumption

  expressed as the average consumption per drinking day

  12 weeks

Secondary Outcomes (2)

• Improvement in depressive or anxiety symptoms

  12 weeks

• Diagnosis severity

  16 weeks

Study Arms (2)

Integrated care

EXPERIMENTAL

Integrated care: Intervention for co-morbid alcohol dependence and anxiety or mood disorder. Trained therapists will deliver specific Cognitive Behavioural Therapy based upon interventions that have been supported by randomised controlled trials for alcohol use, anxiety, and depressive disorders.

Behavioral: Integrated care

Usual care

ACTIVE COMPARATOR

Usual care

Behavioral: Usual care

Interventions

Integrated care BEHAVIORAL

Intervention for co-morbid alcohol dependence and anxiety or mood disorder. Trained therapists will deliver specific Cognitive Behavioural Therapy based upon interventions that have been supported by randomised controlled trials for alcohol use, anxiety, and depressive disorders.

Integrated care

Usual care BEHAVIORAL

Counselling for all subjects will continue in accord with standard practice. Currently, programs of brief individualized motivation enhancement therapy (feedback of assessment findings, reinforcement, empathy, client's own motivation) are available.

Usual care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• alcohol dependence according to DSM-IV criteria, with alcohol as the subject's drug of choice,
• age 18-65,
• adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination),
• willingness to give written consent,
• abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone),
• resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), and a positive score on the initial comorbidity suspicion checklist (CSC).

You may not qualify if:

• sensitivity to study medications or therapy with these drugs within 6 months,
• active major psychiatric disorder associated with significant suicide risk,
• pregnancy or lactation,
• advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy),
• other serious medical illness that would interfere with adherence to the study protocol.
• Entry criteria to step 2:
• Completion of 3 weeks on acamprosate and/or natlrexone and/or, resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale),
• case formulation and diagnosis for anxiety or depression (see below).
• Non-compliance on acamprosate and/or naltrexone,
• alcohol consumption at baseline levels,
• resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment

Sponsors & Collaborators

• South West Sydney Local Health District: lead
• University of Sydney: collaborator

Study Sites (1)

Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Related Publications (2)

• Morley KC, Baillie A, Leung S, Sannibale C, Teesson M, Haber PS. Is Specialized Integrated Treatment for Comorbid Anxiety, Depression and Alcohol Dependence Better than Treatment as Usual in a Public Hospital Setting? Alcohol Alcohol. 2016 Jul;51(4):402-9. doi: 10.1093/alcalc/agv131. Epub 2015 Dec 15.

  PMID: 26672793 DERIVED

• Morley KC, Baillie A, Sannibale C, Teesson M, Haber PS. Integrated care for comorbid alcohol dependence and anxiety and/or depressive disorder: study protocol for an assessor-blind, randomized controlled trial. Addict Sci Clin Pract. 2013 Nov 19;8(1):19. doi: 10.1186/1940-0640-8-19.

  PMID: 24245491 DERIVED

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders; Depression

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrew Baillie

  Macquarie University

  PRINCIPAL INVESTIGATOR

• Paul Haber

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 13, 2013
• Study Start: March 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2013
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

AU (1)