Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000819224
Ethics application status
Approved
Date submitted
17/09/2009
Date registered
18/09/2009
Date last updated
22/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Behaviour Therapy: Treatment Administered Via Videoconference Versus In-Person
Scientific title
The Efficacy & Effectiveness of Videoconference-Based Cognitive-Behavioural Therapy for the Treatment of Psychological Disorders: A Multi-Method Investigation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In accordance with the Diagnositic Statistical Manual of mental disorder-4th edition, participants will have to meet the criteria for a diagnosis on the depression and anxiety spectrum, which includes but not limited to; depression, dysthymia, generalized anxiety disorder, panic disorder with and without agoraphobia, social phobia, specific phobia, obsessive-compulsive disorder and post-traumatic stress disorder. 243862 0
Condition category
Condition code
Mental Health 240035 240035 0 0
Depression
Mental Health 240036 240036 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coginitive Behavioural Therapy via Videoconference. The first session will be in-person and the purpose will be assessment and diagnosis. If selected to recieve treatment via videoconference participants will be given 12 weeks of structured cognitive behavioural therapy. Each session will be conducted weekly for one hour at a time most convient to both the therapist and participant. There will be a total of 13 sessions. Participants will be measured on several symptom measure before treatment, at the end of treatment and then 6-weeks after treatment has ended. The cognitive behaviour therapy adminstered will be tailored to suit each participants presenting issues. Furthermore, upon ending treatment a treatment satisfaction measure will be given.
Intervention code [1] 241300 0
Treatment: Other
Comparator / control treatment
Coginitive Behavioural Therapy administered in-person. The first session (assessment and diagnosis) and will last approximatly an hour. There will be a total of 12 treatment sessions held at weekly intervals, whcih will be in-person. Each treatment session will be one hour long. Participants will be measured on several symptom measure before treatment, at the end of treatment and then 6-weeks after treatment has ended. The cognitive behaviour therapy adminstered will be tailored to suit each participants presenting issues. Furthermore, upon ending treatment a treatment satisfaction measure will be given. In total there will be 13 sessions, one hour each, at weekly intervals.
Control group
Active

Outcomes
Primary outcome [1] 240935 0
To determine the efficacy of cognitive behavioural psychotherapy via videoconference.

Structured Interview For the DSM-IV- will be used for assessmetn and diagnosis.
Primary Measures:
Depression Anxiety Stress scale (DASS)
Quality Of Life & Satisfaction Questionnaire (Q-LES)
This will assessed by using a 2x3 (VC-F2F x pre-post-follow up) Analysis of Covariance.
Timepoint [1] 240935 0
November 2009- January 2011

All participants will be treated within this period. When their assessment/diagnosis occurs depend on when they are referred to the Curtin Psychology Clinic. The questionnaires used on the day of the first assessment will constitute the pre-treatment measure. Treatment will be conducted for a maximum of 12 weeks. Measures administered at the start of treatment will also be provided at the end of treatment (post-treatment data). Then 6-weeks after treatment has ended the same questionnaires will be given to participants, which will constitute the follow-up data.
Secondary outcome [1] 257655 0
To analyze the clinical significance and reliable change of pre-post-follow up participant scores.

In addition to the primary measure, participants will be given an additional symptom specific measure that is more relevant to their primary diagnosis. For example-
Depression-Beck depression inventory
Social phobia- brief fear of negative evaluation
Panic disorder- anxiety sensitivity index
Post traumatic stress disorder- Impact of events scale
Obsessive compulsive disorder- Obsessive compulsive inventory
Generalized anxiety disorder- penn state worry questionnaire
For other non specificed depression/anxiety disorders the depression and anxiety stress scale (DASS) will suffice.
These measures will be used to calculate the clinical significance and reliable change.
Timepoint [1] 257655 0
November 2009- January 2011

All participants will be treated within this period. When their assessment/diagnosis occurs depend on when they are referred to the Curtin Psychology Clinic. The specific symptom measure will be administered before their first treatment session and will constitute the pre-treatment measure. Treatment will be conducted for a maximum of 12 weeks. Measure administered at the start of treatment will also be provided at the end of treatment (post-treatment data). Then 6-weeks after treatment has ended the same questionnaire will be given to participants, which will constitute the follow-up data.

Eligibility
Key inclusion criteria
Diagnostic Statistical Manual for mental disorder (4th Edition): diagnosis on the depression and anxiety spectrum, which includes but not limited to; depression, dysthymia, generalized anxiety disorder, panic disorder with and without agoraphobia, social phobia, specific phobia, OCD and PTSD.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anorexia, Personality disorder as the primary diagnosis, Self-harming/suicidal, Involved in legal proceedings, Psychosis (past or present)

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)
After being referred to the Curtin Adult Psychology Clinic, the first one or two sessions will be to determine a diagnosis. These sessions will be done by a therapist in person. Then, participants will be randomly selected to receive treatment either in-person or via videoconference. Therapy done in-person will not be different from standard practice. If selected to receive treatment via videoconference participants will not be in the same room as their therapist. When participants arrive at the clinic they will be guided into a private room. In this room participants will be able to hear and see their therapist via a computer. Participants will not need to know how to use the computer. All participants will be asked to complete several brief questionnaires. These questionnaires will be given to participants when treatment begins and 12-weeks later, when treatment ends. Finally, these questionnaires will be sent to you by post (with a payed return envelope) 6-weeks after treatment has ended. The method of allocation consealment involved contacting the holder of the allocation schedule who was at the central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomized list of 0's and 1's, whereby 0= the inperson condition and 1= the videoconference condition, was generated for 200 potential participants using a random generator from the site http://graphpad.com/quickcalcs/randomize1.cfm
Masking / blinding
Open (masking not 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
2/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
115
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243755 0
University
Name [1] 243755 0
Curtin University of Technology
Country [1] 243755 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Kent Street, Bentley 6102, Western Australia
Country
Australia
Secondary sponsor category [1] 237111 0
None
Name [1] 237111 0
Address [1] 237111 0
Country [1] 237111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243884 0
Human Research Ethics Committee
Ethics committee address [1] 243884 0
Ethics committee country [1] 243884 0
Australia
Date submitted for ethics approval [1] 243884 0
17/07/2009
Approval date [1] 243884 0
16/09/2009
Ethics approval number [1] 243884 0
HR 97/2009

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

Contacts
Principal investigator
Name 30298 0
Address 30298 0
Country 30298 0
Phone 30298 0
Fax 30298 0
Email 30298 0
Contact person for public queries
Name 13545 0
Lyn Dawson
Address 13545 0
Adult Psychology Clinic

Curtin University, building 404
Kent Street, Bentley, 6102 Western Australia
Country 13545 0
Australia
Phone 13545 0
+61 8 9266 3436
Fax 13545 0
+61 8 9266 3178
Email 13545 0
[email protected]
Contact person for scientific queries
Name 4473 0
Daniel Robert Stubbings
Address 4473 0
GPO Box U1987 Perth,
Western Australia 6845

Curtin University, Psychology, building 400
Kent Street, Bentley 6102, Perth, Western Australia
Country 4473 0
Australia
Phone 4473 0
+61 8 9266 2559
Fax 4473 0
Email 4473 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.