Clinical trial NCT01941693: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Official title: Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Anxiety
Depression
Keywords: alcohol
anxiety
depression
comorbidity
CBT
Lead sponsor: South West Sydney Local Health District
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2013-09-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Alcohol consumption
timeFrame: 12 weeks
measure: Time to lapse
timeFrame: 12 weeks
measure: amount of alcohol consumption
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement in depressive or anxiety symptoms
timeFrame: 12 weeks
measure: Diagnosis severity
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Drug Health Services, Royal Prince Alfred Hospital
state: New South Wales
Study officials:
affiliation: Macquarie University
name: Andrew Baillie
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Paul Haber
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.