Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001358336
Ethics application status
Approved
Date submitted
8/09/2017
Date registered
27/09/2017
Date last updated
27/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effectiveness of a self help book with no therapist support in the treatment of multiple anxiety disorders.
Scientific title
An evaluation of the efficacy of a transdiagnostic bibliotherapy program for anxiety disorders: A pilot study
Secondary ID [1] 292840 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised anxiety disorder 304681 0
Social anxiety disorder 304682 0
Panic disorder 304683 0
Condition category
Condition code
Mental Health 303995 303995 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suitable participants will be provided with the self-help workbook “Face Your Fears”. This workbook is written by a leading expert in the field of anxiety disorders and contains cognitive-behavioural skills to address all anxiety disorders (i.e. is a transdiagnostic treatment). Participants will be encouraged to follow a schedule of reading rather than reading the whole book at once. The proposed reading schedule will be delivered over an 8 week period and is outlined below. Participants will be informed of this structure in a welcome letter that is provided with the book. Participants are required to read the book and practice the skills described within the book for homework. There is no therapist contact as the participants works through the program. It is anticipated that participants will spend 3-4 hours per week doing the readings and practising the skills.


Week 1 Chapter 1-3 Psychoeducation
Week 2 Chapter 4-6 Rationale for exposure therapy, constructing an exposure hierarchy, and conducting exposures
Week 3 Chapter 7 Eliminating safety behaviors
Week 4 Chapter 8 Cognitive restructuring
Week 5 Chapter 9-11 Information relevant to conducting exposures for specific phobia, panic disorder, and social anxiety disorder.
Week 6 Chapter 12-14 Information relevant to conducting exposures for obsessive compulsive disorder, generalized anxiety disorder, and posttraumatic stress disorder.
Week 7 Chapter 15 Tracking progress
Week 8 Chapter 16 Relapse prevention
Intervention code [1] 299086 0
Behaviour
Intervention code [2] 299087 0
Treatment: Other
Comparator / control treatment
This is an open trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303327 0
Overall Anxiety Severity and Impairment Scale (OASIS)
Timepoint [1] 303327 0
Baseline
Weekly through treatment period
Post-treatment (primary endpoint)
3-month follow up
Secondary outcome [1] 338647 0
Generalized Anxiety Disorder Questionnaire (7-item) (GAD-7)
Timepoint [1] 338647 0
Baseline
Weekly through treatment period
Post-treatment
3-month follow up
Secondary outcome [2] 338648 0
Social Interaction Anxiety Scale (Short Form; SIAS-SF)
Timepoint [2] 338648 0
Baseline
Weekly through treatment period
Post-treatment
3-month follow up
Secondary outcome [3] 338649 0
Panic Disorder Severity Scale (PDSS) (self-report version)
Timepoint [3] 338649 0
Baseline
Weekly through treatment period
Post-treatment
3-month follow up
Secondary outcome [4] 338650 0
NIMH Clinician Global Impression (CGI) Scale (self-report version)
Timepoint [4] 338650 0
Baseline
Weekly through treatment period
Post-treatment
3-month follow up
Secondary outcome [5] 338651 0
Sheehan Disability Scale (SDS)
Timepoint [5] 338651 0
Baseline
Weekly through treatment period
Post-treatment
3-month follow up
Secondary outcome [6] 338652 0
Beck Depression Inventory-II (BDI-II)
Timepoint [6] 338652 0
Baseline
Weekly through treatment period
Post-treatment
3-month follow up
Secondary outcome [7] 338653 0
Client Satisfaction Questionnaire (CSQ)
Timepoint [7] 338653 0
Post-treatment

Eligibility
Key inclusion criteria
1) over 18 years of age;
2) meet criteria for panic disorder (PD), social anxiety disorder (SAD), or generalized anxiety disorder (GAD) as primary diagnosis;
3) have regular access to the internet and an email address;
4) minimum score of 3 (“mildly ill”) on the Clinician Global Impression Scale (Guy, 1976); and
5) were not taking psychiatric medications or had been on a stable dose of psychiatric medications for at least 4 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) moderate or severe risk of suicide;
2) had previous adequate CBT for an anxiety disorder (weekly sessions that included an exposure component and between-session homework); or
3) had a current or past psychotic disorder, bipolar disorder or developmental disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/11/2013
Date of last participant enrolment
Anticipated
Actual
5/02/2016
Date of last data collection
Anticipated
Actual
11/08/2016
Sample size
Target
25
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment outside Australia
Country [1] 9185 0
United States of America
State/province [1] 9185 0
Connecticut

Funding & Sponsors
Funding source category [1] 297471 0
Hospital
Name [1] 297471 0
Hartford Hospital
Country [1] 297471 0
United States of America
Funding source category [2] 297548 0
University
Name [2] 297548 0
University of Tasmania
Country [2] 297548 0
Australia
Primary sponsor type
Hospital
Name
Hartford Hospital
Address
Anxiety Disorders Centre
200 Retreat Ave
Hartford
CT, 06106
USA
Country
United States of America
Secondary sponsor category [1] 296469 0
University
Name [1] 296469 0
University of Tasmania
Address [1] 296469 0
Department of Psychology
School of Medicine
Faculty of Health
University of Tasmania
Private Bag 30
Hobart
TAS 7001
Country [1] 296469 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298576 0
Tasmania Social Sciences Human Research Ethics Committee
Ethics committee address [1] 298576 0
Ethics committee country [1] 298576 0
Australia
Date submitted for ethics approval [1] 298576 0
Approval date [1] 298576 0
11/08/2015
Ethics approval number [1] 298576 0
Ethics committee name [2] 298687 0
Hartford Hospital Institutional Review Board
Ethics committee address [2] 298687 0
Ethics committee country [2] 298687 0
United States of America
Date submitted for ethics approval [2] 298687 0
Approval date [2] 298687 0
05/03/2013
Ethics approval number [2] 298687 0
WOOT003933HU

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

Contacts
Principal investigator
Name 77530 0
Dr Bethany Wootton
Address 77530 0
School of Behavioural, Cognitive and Social Sciences
University of New England
Armidale, NSW
2351
Country 77530 0
Australia
Phone 77530 0
+61267735798
Fax 77530 0
Email 77530 0
[email protected]
Contact person for public queries
Name 77531 0
Bethany Wootton
Address 77531 0
School of Behavioural, Cognitive and Social Sciences
University of New England
Armidale, NSW
2351
Country 77531 0
Australia
Phone 77531 0
+61267735798
Fax 77531 0
Email 77531 0
[email protected]
Contact person for scientific queries
Name 77532 0
Bethany Wootton
Address 77532 0
School of Behavioural, Cognitive and Social Sciences
University of New England
Armidale, NSW
2351
Country 77532 0
Australia
Phone 77532 0
+61267735798
Fax 77532 0
Email 77532 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
EmbaseAn Evaluation of the Effectiveness of a Transdiagnostic Bibliotherapy Program for Anxiety and Related Disorders: Results From Two Studies Using a Benchmarking Approach.2018https://dx.doi.org/10.1007/s10608-018-9921-x
N.B. These documents automatically identified may not have been verified by the study sponsor.