Alcohol DependenceNCT01941693
A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
A study testing Integrated care in people with Alcohol Dependence and Anxiety, run by South West Sydney Local Health District at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence, Anxiety, Depression
- What is being tested?
- Integrated care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2007to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
About this study
Official title: Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
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.
Read the detailed description
In summary, the specific aims of this project are:
- 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.
- 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:
- Intervention for comorbid anxiety or depression, and
- Usual counseling care.
- Conditions
- Alcohol Dependence, Anxiety, Depression
- Being tested
- Integrated care, Usual care
- Keywords
- alcohol, anxiety, depression, comorbidity, CBT
- Medical subject headings
- Alcoholism, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated careBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrated care |
| Usual care | Active comparator | Usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Time to relapse (>5 drinks on any one day)
Measured: 12 weeks
Time to lapse
time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
Measured: 12 weeks
amount of alcohol consumption
expressed as the average consumption per drinking day
Measured: 12 weeks
Secondary outcomes (2)
Improvement in depressive or anxiety symptoms
DASS 21
Measured: 12 weeks
Diagnosis severity
clinician rated severity from ADIS-IV and HDRS on anxiety and depressive diagnoses.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startMar 2007
- Primary completionDec 2010
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- South West Sydney Local Health District
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, Professor Paul Haber, South West Sydney Local Health District
- Investigators
- Andrew Baillie, Principal investigator, Macquarie UniversityPaul Haber, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941693
- Sponsor's protocol ID
- X05-0279
- Status last verified
- Sep 2013
- First submitted
- 5 Sep 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26672793Morley 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.
PubMed 24245491
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Treatments for Alcohol Dependence: A Randomized Controlled Trial of Structured Stepped-care Intervention for Psychiatric Comorbidity
- ClinicalTrials.gov ID
- NCT01941693
- Acronym / sponsor ID
- X05-0279
- Conditions
- Alcohol Dependence, Anxiety, Depression
- Keywords
- alcohol, anxiety, depression, comorbidity, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- South West Sydney Local Health DistrictUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- Mar 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- Intervention for comorbid anxiety or depression, and
- Usual counseling care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated care | Experimental | Behavioral: Integrated careIntegrated 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 | Active comparator | Behavioral: Usual careUsual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated careIntervention 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. | Behavioural | Integrated care |
| Usual careCounselling 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. | Behavioural | Usual care |
Primary outcome
Alcohol consumption
Time frame: 12 weeks
Time to relapse (>5 drinks on any one day)
Time to lapse
Time frame: 12 weeks
time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption
amount of alcohol consumption
Time frame: 12 weeks
expressed as the average consumption per drinking day
2 secondary outcomes
Improvement in depressive or anxiety symptoms
Time frame: 12 weeks
Diagnosis severity
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- Derived from this study: PubMed 26672793Morley 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.
- Derived from this study: PubMed 24245491Morley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Baillie principal investigator
Macquarie University
Paul Haber principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care in people with Alcohol Dependence and Anxiety, run by South West Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01941693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013; AzTrials last refreshed its copy on 27 Oct 2026.