Trial registered on ANZCTR


Trial ID
ACTRN12611000855921
Ethics application status
Approved
Date submitted
10/08/2011
Date registered
11/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Facing the Fear: An Investigation of Factors Influencing Homework Adherence in the Treatment of Adults with Anxiety Disorders
Scientific title
Investigation of therapeutic outcomes and homework adherence associated with electronic homework reminders, among adult outpatients suffering an anxiety disorder.
Secondary ID [1] 262813 0
Nil
Universal Trial Number (UTN)
U1111-1123-6212
Trial acronym
FtF

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder without Agoraphobia 270522 0
Panic Disorder with Agoraphobia 270523 0
Agoraphobia Without History of Panic Disorder 270524 0
Specific Phobia 270525 0
Social Phobia 270526 0
Obsessive Compulsive Disorder 270527 0
Post-Traumatic Stress Disorder 270528 0
Acute Stress Disorder 270529 0
Condition category
Condition code
Mental Health 270692 270692 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be examining the use electronic homework reminder messages, delivered to participants via mobile phone text messaging. The messages will be tested in an outpatient group therapy setting. Treatment will consist of 9 two hour group therapy sessions conducted weekly, based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Both groups will have access to between session tasks to be completed by paper and pen. The intervention group will receive SMS messages from their therapists throughout the week, reminding them of homework tasks and providing tips. The standard treatment group will not receive SMS messages.
Intervention code [1] 269161 0
Treatment: Other
Intervention code [2] 269164 0
Treatment: Devices
Intervention code [3] 269165 0
Behaviour
Comparator / control treatment
The control group will receive the same 9 week group therapy programme. All therapy and activities will be equivalent. The control group will receive homework tasks in the standard pen and paper format rather than electronically.
Control group
Active

Outcomes
Primary outcome [1] 269403 0
Homework adherence will be measured by scores on the Homework Rating Scales developed by Westra and Dozois, and Kazantzis and Colleagues.
Timepoint [1] 269403 0
Patient and therapist versions of these scales will be completed each week during the eight week trial.
Secondary outcome [1] 287560 0
Anxiety Disorders Interview Schedule - Adult Version to assess diagnostic criteria and clinical severity.
Timepoint [1] 287560 0
Administered pre-treatment, post treatment, and six months following completion of treatment.
Secondary outcome [2] 287561 0
Symptoms of Depression and Anxiety as measured by the Depression and Anxiety Stress Scales 21.
Timepoint [2] 287561 0
Administered pre-treatment, post treatment, and six months following completion of treatment.
Secondary outcome [3] 287562 0
Symptoms of distress as measured by the Outcome Questionnaire 45.
Timepoint [3] 287562 0
Administered pre-treatment, post treatment, and six months following completion of treatment.
Secondary outcome [4] 287563 0
Affect - as measured by the Positive and Negative Affect Scales.
Timepoint [4] 287563 0
Administered pre-treatment, post treatment, and six months following completion of treatment.
Secondary outcome [5] 287564 0
Impairment in Functioning - as measured by the Work and Social Adjustment Scale.
Timepoint [5] 287564 0
Administered pre-treatment, post-treatment, and at six month follow up.
Secondary outcome [6] 287565 0
Working Alliance - as measured by the Working Alliance Inventory - Short Revised.
Timepoint [6] 287565 0
Administered after session 2 of therapy.
Secondary outcome [7] 287566 0
Group Climate - as measured by the Group Climate Questionnaire.
Timepoint [7] 287566 0
Administered after session 2 of therapy.
Secondary outcome [8] 287567 0
Group Cohesion - as measured by the cohesiveness subscale of the Therapeutic Factors Inventory.
Timepoint [8] 287567 0
Administered after session 2 of therapy.

Eligibility
Key inclusion criteria
A clinical diagnosis of an Anxiety Disorder found in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revised. Diagnosis will be assessed using the ADIS-L structured interview.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current diagnosis, or history of, mania, psychosis, substance dependence, or recurring suicidal ideation.

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)
Allocation is concealed based on central randomization by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who meet criteria for inclusion in the study will be randomly allocated to conditions, according to simple randomization procedures - computerized random numbers created by ClinTools software (Devilly, 2007).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/09/2011
Actual date of first participant enrolment
2/01/2012
Anticipated date last participant enrolled
31/12/2014
Actual date last participant enrolled
Target sample size
98
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269638 0
University
Name [1] 269638 0
Griffith University
Address [1] 269638 0
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
Country [1] 269638 0
Australia
Primary sponsor type
Individual
Name
Leanne Casey
Address
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
Country
Australia
Secondary sponsor category [1] 266668 0
Individual
Name [1] 266668 0
Bonnie Clough
Address [1] 266668 0
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
Country [1] 266668 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269583 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 269583 0
Griffith University, Brisbane Australia
Ethics committee country [1] 269583 0
Australia
Date submitted for ethics approval [1] 269583 0
11/07/2011
Approval date [1] 269583 0
22/07/2011
Ethics approval number [1] 269583 0
PSY/19/11/HREC

Summary
Brief summary
The aim of this study is to investigate the use of a therapeutic Smartphone application in the delivery of thearpy homework. It is expected that the electronic delivery of homeowrk tasks will facilitate greater patient adherence with these tasks, when compared to pen and paper delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33000 0
Dr Dr. Leanne Casey
Address 33000 0
Leanne Casey PhD MAPS MCCP
Director of Clinical Psychology Programs
School of Applied Psychology
Mt Gravatt Campus
Griffith University
Mt Gravatt 4122, Australia
Country 33000 0
Australia
Phone 33000 0
3735 3314
Fax 33000 0
Email 33000 0
l.casey@griffith.edu.au
Contact person for public queries
Name 16247 0
Miss Bonnie Clough
Address 16247 0
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
Country 16247 0
Australia
Phone 16247 0
+61 7 37353348
Fax 16247 0
Email 16247 0
b.clough@griffith.edu.au
Contact person for scientific queries
Name 7175 0
Dr Dr. Leanne Casey
Address 7175 0
School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
Country 7175 0
Australia
Phone 7175 0
+61 7 37353314
Fax 7175 0
Email 7175 0
l.casey@griffith.edu.au