Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000455066
Ethics application status
Approved
Date submitted
1/06/2010
Date registered
3/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behavioural Therapy for the Treatment of Anxiety and Depression in Parkinson’s Disease
Scientific title
Randomised Controlled Trial of Cognitive Behavioural Therapy for the Treatment of Anxiety and Depression in Parkinson’s Disease
Secondary ID [1] 251919 0
Nil
Universal Trial Number (UTN)
U1111-1115-0222
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 257370 0
Depression 257371 0
Anxiety 257372 0
Condition category
Condition code
Neurological 257516 257516 0 0
Parkinson's disease
Mental Health 257517 257517 0 0
Depression
Mental Health 257518 257518 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioural Therapy (CBT) adapted specifically for people with Parkinson's Disease experiencing anxiety and depression. Topics covered in therapy include relaxation techniques, cognitive modification (eg, automatic thoughts, recognising unhelpful thinking styles), behavioural modification and active coping. The treatment will be run in a group format of 6-8 participants and facilitated by two therapists. Treatment comprises 8 weekly sessions, each of 2-hour duration.
Intervention code [1] 256476 0
Behaviour
Intervention code [2] 256613 0
Treatment: Other
Comparator / control treatment
A delayed treatment/wait-list control will be used. Participants randomised to the wait-list condition will be advised on a 8-week period of symptom monitoring prior to treatment, following which they will receive the same treatment as participants allocated to the treatment condition. The 8-weeks of no treatment will serve as the control.
Control group
Active

Outcomes
Primary outcome [1] 258565 0
Depression (as measured by the Depression scale of the Depression, Anxiety and Stress Scale-21; DASS-21)
Timepoint [1] 258565 0
Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.
Secondary outcome [1] 264423 0
Anxiety (as measured by the Anxiety scale of the Depression, Anxiety and Stress Scale-21; DASS-21)
Timepoint [1] 264423 0
Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.
Secondary outcome [2] 264424 0
Stress (as measured by the Stress scale of the Depression, Anxiety and Stress Scale-21; DASS-21)
Timepoint [2] 264424 0
Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.
Secondary outcome [3] 264425 0
Parkinson's Disease specific Quality of Life (as measured by the Parkinson's Disease Questionnaire-39; PDQ-39).
Timepoint [3] 264425 0
Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.
Secondary outcome [4] 264426 0
Depressive and Anxious cognitions (as measured by the Cognitive Check-List; CCL)
Timepoint [4] 264426 0
Pre-treatment, Post-treatment, 1-month follow-up and 6-month follow-up.

Eligibility
Key inclusion criteria
1) At least 6-months post-diagnosis of Parkinson’s Disease
2) Stable use of antiparkinsonism medications
3) Meet the criteria for depression and/or any anxiety disorder as outlined in the American Psychiatric Association's
Diagnostic and Statistical Manual of Mental Disorders Version 4; Text-Revision (DSM-IV-TR)
4) If on antidepressant medication, this must have been stabilised (same medication and dosage) for at least 3 months prior to baseline assessment
5) If on antidepressant medication, agreement to remain on the same medication and dosage over the duration of the study where possible
6) Agreement to not pursue other psychological treatments during the course of the study and over the 6-month follow-up period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Undergoing concurrent psychological treatment
2) Individuals who exhibit cognitive impairment (defined as a Mini Mental State Examination score < 24)
3) Meet DSM-IV-TR criteria for Psychosis
4) Show high suicide risk (defined as meeting the diagnosis for Current Suicidality as assessed by the Mini Neuropsychiatric Interview; MINI)

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)
Participants will be recruited from a number of sources (eg, advertising, referrals from from health professionals etc) and assessed for suitability to participate in the study. Eligible participants will be randomised to either the CBT or Wait-list condition. A randomisation list will be computer generated by a person external to the study. The list will not be made available to the immediate research team during the recruitment and assessment process to limit any potential selection bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation stratified by timing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All participants will ultimately receive the same intervention throughout the study. However, those randomly allocated to the wait-list condition will receive treatment after a period of 8-weeks of no treatment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257089 0
University
Name [1] 257089 0
Curtin University of Technology
Country [1] 257089 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
School of Psychology and Speech Pathology
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country
Australia
Secondary sponsor category [1] 256346 0
None
Name [1] 256346 0
Address [1] 256346 0
Country [1] 256346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259115 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 259115 0
Ethics committee country [1] 259115 0
Australia
Date submitted for ethics approval [1] 259115 0
Approval date [1] 259115 0
01/12/2009
Ethics approval number [1] 259115 0
HR 142/2009

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

Contacts
Principal investigator
Name 31165 0
Address 31165 0
Country 31165 0
Phone 31165 0
Fax 31165 0
Email 31165 0
Contact person for public queries
Name 14412 0
Ms Lakkhina Troeung
Address 14412 0
School of Psychology and Speech Pathology
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country 14412 0
Australia
Phone 14412 0
+61892669101
Fax 14412 0
Email 14412 0
[email protected]
Contact person for scientific queries
Name 5340 0
Ms Lakkhina Troeung
Address 5340 0
School of Psychology and Speech Pathology
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country 5340 0
Australia
Phone 5340 0
+61892669101
Fax 5340 0
Email 5340 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.