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

South West Sydney Local Health District

Status: Completed

Conditions: Depression; Anxiety; Alcohol Dependence

Treatments: Behavioral: Integrated care; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01941693

X05-0279

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Step 1:

• 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).

Exclusion Criteria for Step 1:

• 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).

Exclusion criteria 2:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Integrated care

Experimental group

Description:

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.

Treatment:

Behavioral: Integrated care

Usual care

Active Comparator group

Description:

Usual care

Treatment:

Behavioral: Usual care