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Trial registered on ANZCTR


Registration number
ACTRN12613000226707
Ethics application status
Approved
Date submitted
22/02/2013
Date registered
25/02/2013
Date last updated
25/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial of a self- directed cognitive behavioural therapy (CBT) booklet targeting anxiety throughout treatment of alcohol dependence
Scientific title
A pilot randomised controlled trial of a self- directed cognitive behavioural therapy (CBT) booklet targeting anxiety throughout treatment of alcohol dependence.
Secondary ID [1] 282013 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 288453 0
Alcohol dependence 288454 0
Condition category
Condition code
Mental Health 288797 288797 0 0
Anxiety
Mental Health 288798 288798 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A self-directed Cognitive Behavioural Therapy (CBT) booklet based on CBT techniques/exercises/information derived from basic CBT methods that have been utilised in the past and have been proven in their reliability and validity (Beck 1963; Greenberger and Padesky 1995; von Wietersheim, Scheib et al. 2001; Leahy 2003). The booklet itself for managing anxiety during treatment for alcohol dependence was developed as part of an Honours project at the University of South Australia.

The booklet consists of 4 CBT exercises to be completed over 4 weeks (1 exercise per week). The first weeks exercise is title "Understand your thinking" and introduces the basic concepts of CBT and turnging unhelpful thoughts in to helpful thoughts. Pariticpants are asked to record information about situations that make them feel stressed and to think about the events that lead up to the stress, whether or not their thougths are unhelpful and if thie anxiety could have been avoided if theie thoughts were helpful.

The second weeks exercise is titled "Confronting fearful situations" and helps the individual to divide their fearful situation in to smaller more manageable stepping stones. The indiviudal then works through their stepping stones until they have worked through them all to confront their fearful situation.

Week three is titled "Coping strategies" and helps the individual to practice helpful coping skills instead of unhelpful coping strategies.

The final week, week 4 is titled "Learn to be assertive" and helps individuals to be assertive through acknowledging, declining, explaining and suggesting alternative options.

Beck, A. T. (1963). "Thinking and Depression. I. Idiosyncratic Content and Cognitive Distortions." Archives of General Psychiatry 9: 324-333.

Padesky CA, Greenberger D (1995). Mind Over Mood: Change How You Feel By Changing the Way You Think, The Guilford Press: New York

von Wietersheim, J., et al. (2001). "[The effects of psychotherapy on Crohn's disease patients--results of a randomized multicenter study]." Psychother Psychosom Med Psychol 51(1): 2-9.

Leahy, R. L. (2003). Psychology and the economic mind: Cognitive processes and conceptualization. New York: Springer Publishing Co.
Intervention code [1] 286584 0
Behaviour
Comparator / control treatment
Standard care for Alcohol Use Disorder treatment (including information handout for referral to ongoing anxiety services).
Control group
Active

Outcomes
Primary outcome [1] 288937 0
Reduced anxiety levels: The State-Trait Anxiety Inventory (STAI) (Spielberger 1983) is used to differentiate between temporary condition of “state anxiety” and the more general and long-standing quality of “trait anxiety”. The scale has 40 items, scored on a 1–4 scale.
Timepoint [1] 288937 0
Four weeks
Secondary outcome [1] 301389 0
Improvement in quality of life: Brief WHOQoL is a generic 26-item quality of life measure derived from WHOQOL-100 (WHO 1998) that presents individual quality of life in four domains: physical, psychological, social relationships and environment on the scale 0-100 with a higher score indicating better quality of life.
Timepoint [1] 301389 0
Four weeks
Secondary outcome [2] 301390 0
Improvement in coping mechanisms: The Brief COPE (Carver 1997) is a short 28-item questionnaire, scored on a 4-point Likert scale, derived from a widely used COPE scale.
Timepoint [2] 301390 0
Four weeks
Secondary outcome [3] 301391 0
Completion of the booklet: patient disclosure
Timepoint [3] 301391 0
Four weeks

Eligibility
Key inclusion criteria
English speaking (participants needed to be able to read the CBT booklet: reading level of 13-15 yr old)

Diagnosed as alcohol dependent according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undergoing physical alcohol withdrawal symptoms.

Diagnosed with another serious mental illness besides anxiety (eg schizophrenia, bipolar, severe depression).

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)
Patients were consecutively randomised at each of the three above mentioned sites into two arms:
1) Standard care for AUD treatment (including information handout for referral to ongoing anxiety services)

2)Self directed four week CBT booklet

Questionnaires to assess outcome measures were administered prior to participant randomisation, the CBT booklet or standard care were then undertaken over a four week period and then questionnaires to assess outcome measures were repeated at the end of the four week follow up period. Participants were contacted on a weekly basis by the research assistant to assess their compliance with the tool. Participants were asked what percentage of the booklet they had completed.

Allocation was not concealed. The principal investigator generated the randomisation and emailed it to the research assistant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was undertaken using the computer program PEPI (RANDOM Version 4). Randomisation was undertaken with a 2:1 ratio, CBT booklet:control.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pilot study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Denial, substance use, behavioural disengagement and self-blame subscales of the Brief COPE were coded as maladaptive coping. Distraction, active coping, emotional support, instrumental support, venting, positive reframing, planning, humour, acceptance, religion were coded as adaptive coping. Normality was checked using the Kolmogorov-Smirnoff’s test. Descriptive statistics including means, SD, medians, inter-quartile ranges, counts and proportions were used to describe the study population in the two treatment arms at baseline. Univariate comparisons were conducted with the t-test and the paired t-test on the STAI, the Brief COPE, and the Brief WHOQOL main scales as they were normally distributed. Brief COPE’s individual subscales were not normally distributed and univariate comparisons were done with the Mann-Whiteney and Wilcoxon Signed Rank tests. The analysis of co-variance was conducted to compare the two treatment groups in anxiety, coping and quality of life post intervention and adjusted for baseline. The level of significance for all the comparisons was set as <.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
9/09/2011
Date of last participant enrolment
Anticipated
1/08/2012
Actual
22/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 658 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 6395 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 286787 0
University
Name [1] 286787 0
University of South Australia, Disvision of Health Sciences, Research Development Grant
Country [1] 286787 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide, South Australia 5000
Country
Australia
Secondary sponsor category [1] 285570 0
None
Name [1] 285570 0
Address [1] 285570 0
Country [1] 285570 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288853 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 288853 0
Royal Adelaide Hospital, North Terrace, Adelaide, South Australia 5000
Ethics committee country [1] 288853 0
Australia
Date submitted for ethics approval [1] 288853 0
05/07/2011
Approval date [1] 288853 0
13/07/2011
Ethics approval number [1] 288853 0
110707
Ethics committee name [2] 288854 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 288854 0
GPO Box 2471, South Australia, Adelaide 5001
Ethics committee country [2] 288854 0
Australia
Date submitted for ethics approval [2] 288854 0
Approval date [2] 288854 0
15/08/2011
Ethics approval number [2] 288854 0

Summary
Brief summary
Alcohol Use Disorder’s (AUD’s) are a growing burden on Australia’s health care system due to associated cardiovascular and gastrointestinal disease, cognitive deficits, insomnia, suicide and other drug abuse, and have illustrated significant co-morbidity with anxiety. Additionally, anxiety is a strong motive for self-medication with further alcohol use, especially during initial detoxification. A major obstacle in AUD treatment is the significant delay in access to treatment, and motivating patients to continue treatment throughout alcohol detoxification and its associated anxiety. The effectiveness of a self directed cognitive behavioural therapy booklet allowing immediate access to treatment to manage anxiety during AUD treatment will be tested in the current study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38074 0
Dr Andrea Gordon
Address 38074 0
GPO Box 2471, Adelaide, South Australia 5001
Country 38074 0
Australia
Phone 38074 0
+61 8 8302 1764
Fax 38074 0
+61 8 8302 2168
Email 38074 0
andrea.gordon@unisa.edu.au
Contact person for public queries
Name 38075 0
Andrea Gordon
Address 38075 0
GPO Box 2471, Adelaide, South Australia 5001
Country 38075 0
Australia
Phone 38075 0
+61 8 8302 1764
Fax 38075 0
+61 8 8302 2168
Email 38075 0
andrea.gordon@unisa.edu.au
Contact person for scientific queries
Name 38076 0
Andrea Gordon
Address 38076 0
GPO Box 2471, Adelaide, South Australia 5001
Country 38076 0
Australia
Phone 38076 0
+61 8 8302 1764
Fax 38076 0
+61 8 8302 2168
Email 38076 0
andrea.gordon@unisa.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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