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

Depression Clinical Trial

Official title:

Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941693
• Other study ID #: X05-0279
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: September 9, 2013
• Start date: March 2007
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: South West Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Anxiety
• Depression

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
Australia	Drug Health Services, Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
South West Sydney Local Health District	University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol consumption	Time to relapse (>5 drinks on any one day)	12 weeks	No
Primary	Time to lapse	time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption	12 weeks	No
Primary	amount of alcohol consumption	expressed as the average consumption per drinking day	12 weeks	No
Secondary	Improvement in depressive or anxiety symptoms	DASS 21	12 weeks	No
Secondary	Diagnosis severity	clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.	16 weeks	No