Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001388303
Ethics application status
Approved
Date submitted
26/09/2017
Date registered
29/09/2017
Date last updated
29/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effectiveness of a self help book with minimal therapist support in the treatment of anxiety and related disorders.
Scientific title
An evaluation of the efficacy of a guided transdiagnostic bibliotherapy program for anxiety and related disorders: A pilot study
Secondary ID [1] 292918 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised anxiety disorder 304794 0
social anxiety disorder 304795 0
panic disorder 304796 0
obsessive compulsive disorder 304797 0
agoraphobia 304798 0
posttraumatic stress disorder 304799 0
specific phobia 304800 0
Condition category
Condition code
Mental Health 304097 304097 0 0
Anxiety
Mental Health 304246 304246 0 0
Other mental health disorders

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. Brief therapist support is provided by phone as the participant works through the program (approximately 10-15 minutes per weekly call). It is anticipated that participants will spend 3-4 hours per week doing the readings and practising the skills and 10-15 minutes each week with the therapist over the phone.

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] 299149 0
Behaviour
Intervention code [2] 299150 0
Treatment: Other
Comparator / control treatment
This is an open trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303418 0
Overall Anxiety Severity and Impairment Scale (OASIS)
Timepoint [1] 303418 0
Baseline
Weekly through treatment period
Post-treatment (primary endpoint)
3-month follow up
Secondary outcome [1] 338884 0
Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)
Timepoint [1] 338884 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [2] 338885 0
Depression, Anxiety, Stress Scale
Timepoint [2] 338885 0
Baseline
Post-treatment
3-month follow up
Secondary outcome [3] 338886 0
NIMH Clinician Global Impression (CGI) Scale (self-report version)
Timepoint [3] 338886 0
Baseline
Weekly through treatment period
Post-treatment
3-month follow up
Secondary outcome [4] 338887 0
Sheehan Disability Scale (SDS)
Timepoint [4] 338887 0
Baseline
Weekly through treatment period
Post-treatment
3-month follow up
Secondary outcome [5] 338888 0
Client Satisfaction Questionnaire (CSQ)
Timepoint [5] 338888 0
Post-treatment

Eligibility
Key inclusion criteria
1) over 18 years of age;
2) meet criteria for panic disorder (PD), social anxiety disorder (SAD), generalized anxiety disorder (GAD), obsessive compulsive disorder (OCD), specific phobia (SP), agoraphobia (AG), or post-traumatic stress disorder (PTSD) 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
12/05/2014
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
16/11/2016
Sample size
Target
45
Accrual to date
Final
41
Recruitment outside Australia
Country [1] 9219 0
United States of America
State/province [1] 9219 0
Connecticut

Funding & Sponsors
Funding source category [1] 297549 0
Hospital
Name [1] 297549 0
Hartford Hospital
Country [1] 297549 0
United States of America
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] 296559 0
None
Name [1] 296559 0
Address [1] 296559 0
Country [1] 296559 0
Other collaborator category [1] 279736 0
University
Name [1] 279736 0
University of Tasmania
Address [1] 279736 0
Department of Psychology
School of Medicine
Faculty of Health
University of Tasmania
Private Bag 30
Hobart
TAS 7001
Country [1] 279736 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298644 0
Hartford Healthcare Institutional Review Board
Ethics committee address [1] 298644 0
Ethics committee country [1] 298644 0
United States of America
Date submitted for ethics approval [1] 298644 0
Approval date [1] 298644 0
05/03/2013
Ethics approval number [1] 298644 0

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

Contacts
Principal investigator
Name 77754 0
Prof David Tolin
Address 77754 0
Anxiety Disorders Centre
200 Retreat Drive
Hartford,
CT, 06106
Country 77754 0
United States of America
Phone 77754 0
+1 860 545 7685
Fax 77754 0
Email 77754 0
[email protected]
Contact person for public queries
Name 77755 0
Bethany Wootton
Address 77755 0
School of Behavioural, Cognitive and Social Sciences
University of New England
Armidale, NSW
2351
Country 77755 0
Australia
Phone 77755 0
+61 2 67735798
Fax 77755 0
Email 77755 0
[email protected]
Contact person for scientific queries
Name 77756 0
Bethany Wootton
Address 77756 0
School of Behavioural, Cognitive and Social Sciences
University of New England
Armidale, NSW
2351
Country 77756 0
Australia
Phone 77756 0
+61 2 67735798
Fax 77756 0
Email 77756 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
No additional documents have been identified.