Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000579998
Ethics application status
Approved
Date submitted
23/05/2011
Date registered
6/06/2011
Date last updated
14/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving the retention rate for residential treatment of substance abuse by sequential intervention for social anxiety.
Scientific title
Improving the retention rate for residential treatment of substance abuse by sequential intervention for social anxiety.
Secondary ID [1] 252375 0
DKU HREC 2010-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and drug use 256631 0
Social Anxiety 258000 0
Condition category
Condition code
Mental Health 256795 256795 0 0
Addiction
Mental Health 258170 258170 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The focus of this study is to examine whether addressing social anxiety disorder (SAD) symptoms, which are directly related to residential substance abuse treatment, improves engagement and retention in individuals with comorbid SAD and substance use.

Participants randomly assigned to the intervention will receive 2 individual and 2 group sessions of SAD symptom-targeted psychological therapy prior to inpatient treatment at Odyssey House, a residential drug and alcohol therapeutic community based in the outer suburbs of Melbourne, Victoria. The group sessions will generally consist of only of 3-4 participants, and will be facilitated by a registered and experienced psychologist. An additional two therapeutic 'booster' telephone counselling sessions will be delivered within the first few weeks of the client's residency at the Therapeutic Community (TC).

The psychological intervention includes psychoeducation, cognitive challenging, reality testing, attention training and facing feared situations in a gradual way. Two randomised control trials support the effectiveness of the program in reducing social anxiety symptoms and other related psychological problems (Rapee, Abbott, Baillie, & Gaston, 2007; Wilson & Rapee, 2005).
Intervention code [1] 255882 0
Treatment: Other
Comparator / control treatment
Standard pre-residential preparatory treatment delivered by Odyssey House Victoria (which primarily targets substance use issues, readiness for change and preparedness for long term residence in TC). Participants assigned to the control group will also receive a written booklet including psychoeducation and information on basic anxiety management strategies.
Control group
Active

Outcomes
Primary outcome [1] 257672 0
Reduce wait list attrition for individuals with comorbid substance use and social anxiety disorders who are awaiting entry to TC: comparison of TC wait list retention rates between intervention and control group.
Timepoint [1] 257672 0
Prior to TC entry
Primary outcome [2] 258908 0
Improve retention rate for residents of the TC who have comorbid substance use and social anxiety disorders: comparison of TC residential retention rates and length of stay (LOS) between intervention and control group.
Timepoint [2] 258908 0
Upon exit from TC
Secondary outcome [1] 262979 0
Reduce social anxiety symptoms directly assoicated with entry and residence in TC for people with comorbid drug and alcohol dependence: Liebowitz Social Anxiety Scale (LSAS; Liebowitz 2002), Brief Fear of Negative Evaluation Scale (BFNE; Watson & Friend, 1969), MINI International Neuropsychiatric Interview (Sheehan, Lecrubier, Sheehan, Amorim, Janavs, Weiller, Hergueta, Baker & Dunbar, 1998), Beck Anxiety Inventory (BAI; Beck & Steer, 1990), Beck Depression Inventory (BDI; Beck & Steer, 1987), Sensitivity to Punishment Sensitivity to Reward Questionnaire (SPSRQ; Torrubia et al., 2001), Willingness to Communicate Scale (WTC; McCroskey & Baer, 1985).
Timepoint [1] 262979 0
Baseline, post-intervention/3-months after entry to TC and/or then 6- months after exiting TC.
Secondary outcome [2] 262980 0
To reduce dependence on drugs and/or alcohol for people with comorbid social anxiety symptoms: The timeline follow back (TLFB; Maisto, Sobell & Cooper, 1979), MINI International Neuropsychiatric Interview (Sheehan, Lecrubier, Sheehan, Amorim, Janavs, Weiller, Hergueta, Baker & Dunbar, 1998), Alcohol, Smoking and Substances Involvement Screening Test (ASSIST; WHO, 2002), Circumstances, Motivation and Readiness Scales for Substance Abuse Treatment (CMR; De Leon, Melnick, Kressel, & Jainchill, 1994), I7 Impulsiveness Questionnaire (I7 EIS; Eysenck, Pearson, Easting & Allsopp, 1985). Urine samples are also collected from a random sample of people to confirm participant self-report of substance use.
Timepoint [2] 262980 0
Baseline, post-intervention/3-months after entry to TC and/or then 6- months after exiting TC.

Eligibility
Key inclusion criteria
Meet criteria for current substance use dependence AND have at least moderate symptoms of social anxiety disorder as indicated by the Liebowitz Social Anxiety Scale (LSAS; Liebowitz 2002).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Meet criteria for a current and active psychotic disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR); (2) suicidal; (3) deemed ineligible for inclusion on TC wait list via intake assessment from Odyssey House Victoria.

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)
Approximately 90 individuals (45 in each group) who provide informed consent will be recruited for participation in this study from Odyssey House Victoria. Participation is voluntary, free of charge and clients are able to withdraw at any stage. In order to ensure comparability between groups, randomisation occurs after recruitment, selection criteria, and baseline assessments have been completed. At baseline all eligible participants will be assigned a numeric code. An independent researcher who is at a central administration site is the holder of a confidential allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2509 0
3121 and surrounding suburbs
Recruitment postcode(s) [2] 2510 0
3093 and surrounding suburbs

Funding & Sponsors
Funding source category [1] 256364 0
Government body
Name [1] 256364 0
Australian Research Council
Country [1] 256364 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
221 Burwood Highway
Burwood
Victoria, 3125
Country
Australia
Secondary sponsor category [1] 251681 0
Other Collaborative groups
Name [1] 251681 0
Odyssey Institute of Studies
Address [1] 251681 0
660 Bridge Road
Richmond
Victoria, 3121
Country [1] 251681 0
Australia
Secondary sponsor category [2] 251682 0
University
Name [2] 251682 0
Swinburne University of Technology
Address [2] 251682 0
Swinburne University of Technology
John St
Hawthorn
VIC 3122
Country [2] 251682 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258435 0
Deakin University Human Research Ethics Unit
Ethics committee address [1] 258435 0
Ethics committee country [1] 258435 0
Australia
Date submitted for ethics approval [1] 258435 0
22/02/2010
Approval date [1] 258435 0
17/05/2010
Ethics approval number [1] 258435 0
2010-007

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

Contacts
Principal investigator
Name 30739 0
Address 30739 0
Country 30739 0
Phone 30739 0
Fax 30739 0
Email 30739 0
Contact person for public queries
Name 13986 0
Associate Professor Petra Staiger
Address 13986 0
School of Psychology
Deakin University
221 Burwood Highway
Burwood Victoria, 3125
Country 13986 0
Australia
Phone 13986 0
+61 3 9244 6876
Fax 13986 0
+61 3 9244 6858
Email 13986 0
[email protected]
Contact person for scientific queries
Name 4914 0
Associate Professor Petra Staiger
Address 4914 0
School of Psychology
Deakin University
221 Burwood Highway
Burwood Victoria, 3125
Country 4914 0
Australia
Phone 4914 0
+61 3 9244 6876
Fax 4914 0
+61 3 9244 6858
Email 4914 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseImproving the retention rate for residential treatment of substance abuse by sequential intervention for social anxiety.2014https://dx.doi.org/10.1186/1471-244X-14-43
N.B. These documents automatically identified may not have been verified by the study sponsor.