Trial from ANZCTR


Trial ID ACTRN12611000855921
Trial Status: Registered
Date Submitted: 10/08/2011
Date Registered: 11/08/2011
Prospectively registered

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Public title Facing the Fear: An Investigation of Factors Influencing Homework Adherence in the Treatment of Adults with Anxiety Disorders
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Investigation of therapeutic outcomes and homework adherence associated with electronic homework reminders, among adult outpatients suffering an anxiety disorder.
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Secondary ID [1] 262813 0
Nil
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UTN U1111-1123-6212
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Trial acronym FtF
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Health condition(s) or problem(s) studied:
Panic Disorder without Agoraphobia 270522 0
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Panic Disorder with Agoraphobia 270523 0
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Agoraphobia Without History of Panic Disorder 270524 0
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Specific Phobia 270525 0
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Social Phobia 270526 0
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Obsessive Compulsive Disorder 270527 0
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Post-Traumatic Stress Disorder 270528 0
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Acute Stress Disorder 270529 0
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Condition category: Condition code:
Mental Health Anxiety
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270692 270692 0 0

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Descriptions 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.
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Intervention Code:
Treatment: Other 269161 0
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Intervention Code:
Treatment: Devices 269164 0
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Behaviour 269165 0
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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.
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Control group Active
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Primary Outcome: Homework adherence will be measured by scores on the Homework Rating Scales developed by Westra and Dozois, and Kazantzis and Colleagues. 269403 0
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Timepoint: Patient and therapist versions of these scales will be completed each week during the eight week trial. 269403 0
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Secondary Outcome: Anxiety Disorders Interview Schedule - Adult Version to assess diagnostic criteria and clinical severity. 287560 0
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Timepoint: Administered pre-treatment, post treatment, and six months following completion of treatment. 287560 0
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Secondary Outcome: Symptoms of Depression and Anxiety as measured by the Depression and Anxiety Stress Scales 21. 287561 0
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Timepoint: Administered pre-treatment, post treatment, and six months following completion of treatment. 287561 0
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Secondary Outcome: Symptoms of distress as measured by the Outcome Questionnaire 45. 287562 0
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Timepoint: Administered pre-treatment, post treatment, and six months following completion of treatment. 287562 0
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Secondary Outcome: Affect - as measured by the Positive and Negative Affect Scales. 287563 0
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Timepoint: Administered pre-treatment, post treatment, and six months following completion of treatment. 287563 0
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Secondary Outcome: Impairment in Functioning - as measured by the Work and Social Adjustment Scale. 287564 0
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Timepoint: Administered pre-treatment, post-treatment, and at six month follow up. 287564 0
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Secondary Outcome: Working Alliance - as measured by the Working Alliance Inventory - Short Revised. 287565 0
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Timepoint: Administered after session 2 of therapy. 287565 0
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Secondary Outcome: Group Climate - as measured by the Group Climate Questionnaire. 287566 0
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Timepoint: Administered after session 2 of therapy. 287566 0
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Secondary Outcome: Group Cohesion - as measured by the cohesiveness subscale of the Therapeutic Factors Inventory. 287567 0
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Timepoint: Administered after session 2 of therapy. 287567 0
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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.
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Current diagnosis, or history of, mania, psychosis, substance dependence, or recurring suicidal ideation.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Allocation is concealed based on central randomization by a computer.
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Describe the 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).
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/09/2011
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Date of first participant enrolment 2/01/2012
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Anticipated date last participant recruited/enrolled 31/12/2014
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Actual date last participant recruited/enrolled
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Target sample size 98
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Recruitment status Recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: University 269638 0
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Name: Griffith University 269638 0
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Address: Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
269638 0
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Country: Australia 269638 0
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Primary Sponsor Individual
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Name: Leanne Casey
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Address: School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
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Country: Australia
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Secondary Sponsor: Individual 266668 0
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Name: Bonnie Clough 266668 0
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Address: School of Psychology
Griffith University, Mt Gravatt Campus
176 Messines Ridge Road
Mt Gravatt, Qld
4111
266668 0
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Country: Australia 266668 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Griffith University Human Research Ethics Committee 269583 0
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Address: Griffith University, Brisbane Australia 269583 0
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Country: Australia 269583 0
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Approval Date: 22/07/2011 269583 0
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Submitted Date: 11/07/2011 269583 0
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HREC: PSY/19/11/HREC 269583 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Dr
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Name: Dr. Leanne Casey
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Address: Leanne Casey PhD MAPS MCCP Director of Clinical Psychology Programs School of Applied Psychology Mt Gravatt Campus Griffith University Mt Gravatt 4122, Australia
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Country: Australia
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Tel: 3735 3314
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Email: l.casey@griffith.edu.au
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Contact person for public queries
Title: Miss
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Name: Bonnie Clough
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Address: School of Psychology Griffith University, Mt Gravatt Campus 176 Messines Ridge Road Mt Gravatt, Qld 4111
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Tel: +61 7 37353348
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Email: b.clough@griffith.edu.au
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Contact person for scientific queries
Title: Dr
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Name: Dr. Leanne Casey
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Address: School of Psychology Griffith University, Mt Gravatt Campus 176 Messines Ridge Road Mt Gravatt, Qld 4111
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Tel: +61 7 37353314
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Email: l.casey@griffith.edu.au
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Contact person responsible for updating information
Title:
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Name: Bonnie Clough
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Address: School of Psychology Griffith University, Mt Gravatt Campus 176 Messines Ridge Road Mt Gravatt, Qld 4111
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Country: Australia
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Tel: +61 7 37353348
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Email: b.clough@griffith.edu.au
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Addition Cancer fields
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