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Trial registered on ANZCTR


Registration number
ACTRN12613000193774
Ethics application status
Approved
Date submitted
14/02/2013
Date registered
19/02/2013
Date last updated
3/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of Mindfulness training people recovering from alcohol dependence.
Scientific title
The efficacy of Mindfulness training on cognitive, affective, and physiological mechanisms implicated in alcohol dependence. A randomized control trial.
Secondary ID [1] 281955 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol dependence 288374 0
Condition category
Condition code
Mental Health 288718 288718 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
While effective treatments are available for mild levels of alcohol and drug dependence the repeated and persistent, long lasting nature of the disorder often involves people attending groups to prevent relapse. One type of approach considers whether by learning to accept and just notice the cravings for substances, instead of trying to suppress or fight off the cravings, makes it easier for people to use different or opposing behaviours to prevent relapse. This study examines the effect of an eight session programme designed to disrupt thoughts, feelings, and bodily functions implicated in stress-initiated relapse to alcohol consumption.

The intervention will compare a Mindfulness based intervention adapted from Mindfulness-Based Cognitive Therapy for Depression (Segal et al . 2002) with a standard alcohol support group (ASG) treatment. Participants will be randomly assigned to one of two conditions:

Mindfulness groups: 8 x 1.25 hr /week of mindfulness training (n=14, 2 groups, Total n=28)

ASG Groups: 8 x 1.25 hr /week of ASG (n=14, 2 groups, Total =28)

Session-Specific Description of Mindfulness and ASG Interventions
Session Mindfulness Based Intervention
1. Discussion of mindfulness and automatic drinking; mindfulness of craving; mindful breathing and body scan

2. Discussion of cognitive reappraisal; practice of mindful de-centring and mindful breathing

3. Discussion of attentional re-orienting as means of coping with negative emotions and craving; mindful breathing; mindfulness of perceptions & sensations

4. Discussion of craving; practice of "urge surfing," mindfulness of craving, and contemplation of negative consequences of drinking; imaginal alcohol cue exposure; mindful breathing practice

5. Discussion of the relationship of the stress response to craving; imaginal stress exposure; mindful breathing

6. Discussion of thought suppression, aversion, and attachment; exercise in the futility of thought suppression; mindful breathing and acceptance

7. Discussion of relational triggers for relapse; mindful communication; compassion meditation

8. Breathing Review; discussion of how to maintain mindfulness practice; development of mindful relapse prevention plan; imaginal rehearsal of mindful relapse prevention; mindful breathing

Session: ASG treatment
1. Discussion of triggers for alcohol dependence relapse

2. Discussion of justifications for relapse and using alcohol to mask one's emotions

3. Discussion of how participants cope with emotions of anger and sadness

4. Discussion of how participants cope with craving and managing compulsive behavior

5. Discussion of stress and methods participants use to relax without alcohol

6. Discussion of the attempt to maintain control and loss of control

7. Discussion of physical health promotion and ways to recreate without alcohol

8. Discussion of co-dependence relationships and the challenge of forming friendships without alcohol
Intervention code [1] 286522 0
Behaviour
Intervention code [2] 286523 0
Rehabilitation
Comparator / control treatment
The Mindfulness based intervention will be evaluated against the Alcohol Support Group (ASG) Standard treatment (CBT and social skills)
Control group
Active

Outcomes
Primary outcome [1] 288863 0
Brief Symptom Inventory (Derogatis & Melisaratos, 1983) measures the degree to which participants are distressed by psychiatric symptoms.
Timepoint [1] 288863 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.
Primary outcome [2] 288864 0
Alcohol craving frequency and intensity Penn Alcohol Craving Scale (Flannery et al., 2001)
Timepoint [2] 288864 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.
Primary outcome [3] 288865 0
Impaired Alcohol Response Inhibition Scale (Guardia et al., 2007)
Timepoint [3] 288865 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.
Secondary outcome [1] 301183 0
Perceived Stress Scale (Cohen, Kamarck & Mermelstein, 1983)
Timepoint [1] 301183 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.
Secondary outcome [2] 301184 0
White Bear (thought) Suppression Inventory (Wegner & Zanakos, 1994) a measure of thought suppression to avoid or repress undesired cognitions and emotions.
Timepoint [2] 301184 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.
Secondary outcome [3] 301185 0
Psychophysiological cue-reactivity:(HRV recovery, that is, changes in HRV between alcohol cue exposure and the recovery period) using Emwave finger sensors.
Timepoint [3] 301185 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.
Secondary outcome [4] 301186 0
Attitudes Towards Treatment Questionnaire (Borkovec & Nau, 1972)
Timepoint [4] 301186 0
After session 2 and session 8 for each treatment condition
Secondary outcome [5] 301187 0
Kentucky Inventory of Mindfulness Skills Questionnaire(Baer et al., 2004).
Timepoint [5] 301187 0
Pre-treatment, after 4 treatment sessions, post-treatment and 3 months post-treatment follow-up.

Eligibility
Key inclusion criteria
Participants must be 18 years of age or older (male or female)

Residents of the therapeutic community

Meet (DSM-IV) alcohol dependence criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who scores less than 16 on the AUDIT (Babor et al. 2001)

Who have an active psychosis (Degenhardt et al., 2005)

Suicidality

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All the people who are currently in the therapeutic community will be invited to attend an informal presentation about the study conducted by the student investigator and clinical psychologist at the therapeutic community. The prospective participants will receive the following information:

Nature and Purpose of the Study
What the Study will Involve
Voluntary Participation and Withdrawal from the Study
Benefits of the Study
Possible Risks
Reimbursement

People who would like to participate may do so at the end of the presentation by signing the consent form in the presence of the presenters. Persons wishing to consider their participation can do so during the following week and can complete the consent form in the presence of the clinical psychologist at the therapeutic community. Two weeks following the informal presentation participants will becontacted and interviewed to check that they have given formal written consent by a research assistants who will conduct screening interviews.

Participants meeting inclusion criteria will be allocated a number by the therapeutic community clinical psychologist. The list of participants and their assigned codes will be held in a locked filing cabinet at the therapeutic community administration. The student researcher will not have access to this list. Data will only have the de-identified two number code for analysis purposes. A random sample calculator will be used to allocate participants to one of two treatment conditions. Participants will be asked not to discuss treatment experiences between the two conditions during the period of the research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sample calculator (graphpad.com) will be used to randomly assign subjects to treatment groups.

The total population (56) at the Therapeutic Community will be offered both treatments at the completion of the 3 month follow up stage.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Bivariate correlations
Pearson’s r: relationship between two variables 0-1

t-tests
assess whether means of two groups are statistically different from each other

chi-square
significant difference between the expected frequencies and the observed frequencies in one or more category

repeated-measures analyses of variance (ANOVA) SPSS 18.0
When several measurements are taken on the same experimental unit ie. treatment

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
20/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6343 0
6077 - Gnangara

Funding & Sponsors
Funding source category [1] 286733 0
Self funded/Unfunded
Name [1] 286733 0
Country [1] 286733 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
South St Murdoch
WA 6150
Country
Australia
Secondary sponsor category [1] 285509 0
None
Name [1] 285509 0
Address [1] 285509 0
Country [1] 285509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288807 0
Human Research ethics Committee
Ethics committee address [1] 288807 0
Ethics committee country [1] 288807 0
Australia
Date submitted for ethics approval [1] 288807 0
16/11/2012
Approval date [1] 288807 0
01/02/2013
Ethics approval number [1] 288807 0
2012/202

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34811 0
Dr Christopher Lee
Address 34811 0
Room 2.038, Social Science Building, 90 South Street, Murdoch WA 6150
Country 34811 0
Australia
Phone 34811 0
+61 8 93606828
Fax 34811 0
Email 34811 0
chris.lee@murdoch.edu.au
Contact person for public queries
Name 18058 0
Sandro Gilomen
Address 18058 0
23 Gifford Road Dunsborough 6281 Western Australia
Country 18058 0
Australia
Phone 18058 0
+61 0400321272
Fax 18058 0
Email 18058 0
sandro@sgpsychology.com.au
Contact person for scientific queries
Name 8986 0
Sandro Gilomen
Address 8986 0
23 Gifford Road Dunsborough 6281 Western Australia
Country 8986 0
Australia
Phone 8986 0
+61 0400321272
Fax 8986 0
Email 8986 0
sandro@sgpsychology.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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