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

Not Applicable

Completed

• Conditions: Alcohol Dependence; Anxiety; Depression
• Interventions: Behavioral: Integrated care; Behavioral: Usual care

• Registration Number: NCT01941693
• Lead Sponsor: South West Sydney Local Health District

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.

Detailed Description

In summary, the specific aims of this project are:

1. To assess the effectiveness of a novel stepped care intervention for alcohol dependent patients with co-morbid anxiety and/or depression compared to usual treatment for alcohol dependence in promoting abstinence from alcohol and increased quality of life and in reducing symptoms of anxiety and depression.

2. To describe important factors relating to the maintenance of alcohol-related psychiatric comorbidity.

Step 1: All subjects will complete 12 weeks of pharmacotherapy (n = 120) on naltexone (50 mg, 1 tablet daily), acamprosate (333 mg, 2 tablets 3 times daily, reduced to 4/day for women \<65kg), or a combination of the two. After a 3 week stabilization period, subjects will undergo complete formal assessment for anxiety and depression. Those subjects with a diagnosis of anxiety or depressive disorder regardless of drinking outcome will be offered the next step of care and followed up at 12-16 weeks.

Step 2: Subjects to undergo the next step of care (n = 30 per group, 60 in total) will be randomized by referring to the consecutively assigned subject identification number to a matched numbered envelope containing a random assignment card. Randomization will be stratified according to concomitant SSRI use. The treatment groups will be:

1. Intervention for comorbid anxiety or depression, and

2. Usual counseling care.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2010-12
• Study Completion: 2013-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-09
• Last Update Submitted: 2013-09-09
• Study First Posted: 2013-09-13
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated care	Integrated care	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.
Usual care	Usual care	Usual care

Primary Outcome Measures

Name	Time	Method
Alcohol consumption	12 weeks	Time to relapse (\>5 drinks on any one day)
Time to lapse	12 weeks	time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
amount of alcohol consumption	12 weeks	expressed as the average consumption per drinking day

Secondary Outcome Measures

Name	Time	Method
Improvement in depressive or anxiety symptoms	12 weeks	DASS 21
Diagnosis severity	16 weeks	clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.

Trial Locations

Locations (1)

Drug Health Services, Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia