Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001122549
Ethics application status
Approved
Date submitted
8/10/2015
Date registered
23/10/2015
Date last updated
8/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the treatment of depression and quality of life in Parkinson’s disease: A randomised controlled trial
Scientific title
Efficacy of mindfulness based cognitive therapy for the treatment of depression in idiopathic Parkinson's disease.
Secondary ID [1] 287592 0
Nil known
Universal Trial Number (UTN)
U1111-1175-1631
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 296388 0
Depression 296389 0
Anxiety 296390 0
Quality of life 296391 0
Condition category
Condition code
Neurological 296661 296661 0 0
Parkinson's disease
Mental Health 296662 296662 0 0
Anxiety
Mental Health 296663 296663 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an 8-week Mindfulness based cognitive therapy (MBCT) program, which is designed to reduce depression, anxiety, and stress, with a particular focus on preventing relapse of depression. The MBCT program that will be used for the current study is an adapted version of Segal, Williams, and Teasdales's 2012 MBCT program which has been specialised for people with PD. This intervention program consists of 8 sessions (90 minutes each) which will run once per week across an 8-week period. The program targets skills such as concentration, awareness of thoughts, emotions, and bodily sensations, decentering, acceptance, letting go, and being in a state of “being” rather than “doing”. An additional session (lasting approximately one hour) for partners/carers of the participants with PD will be conducted early in the MBCT treatment (around session 2). This session will aim to help partners/carers of people with PD to understand psychological problems that occur in PD such as anxiety. It will also aim to teach them about mindfulness and encourage them to become actively involved in the mindfulness practice homework with their partner/carer. The MBCT group sessions will involve face to face sessions in small groups of participants (approximately 6-8). Trainee clinical psychologists will be running the sessions. There will be a register of attendance at sessions.
Intervention code [1] 292992 0
Treatment: Other
Intervention code [2] 293079 0
Behaviour
Comparator / control treatment
The control treatment in this study is an 8-week Supportive Psychotherapy program. Sessions will run for 120 minutes, once weekly for an 8-week period. The researchers of this study will write a brief Supportive Psychotherapy treatment plan for the clinicians to follow. This will include standard non-specific “common factors” of psychotherapy including empathy, using the therapeutic relationship, group cohesion, active listening, group support, paraphrasing, genuineness, warmth and positive regard. The SP treatment plan is based on a detailed text on non-specific, common factors (Yalom, 1995). The participants will not be provided with any specific coping skills. Groups will include a small number of participants (6-8). Trainee clinical psychologists will run these sessions. A register of attendance will be completed each session to monitor adherence.
Control group
Placebo

Outcomes
Primary outcome [1] 296273 0
Mean score on Geriatric Depression Scale
Timepoint [1] 296273 0
Baseline, post-intervention, and 3 and 6 months following the intervention
Secondary outcome [1] 318020 0
Mean score on the Geriatric Anxiety Inventory
Timepoint [1] 318020 0
Baseline, post-intervention, and 3 and 6 months following intervention
Secondary outcome [2] 318021 0
Mean score on Parkinson's Disease Questionnaire (Quality of life measure)
Timepoint [2] 318021 0
Baseline, post-intervention, and 3 and 6 months following intervention.
Secondary outcome [3] 318022 0
Mean score on the Caregiver Burden Inventory as completed by the partner/caregiver
Timepoint [3] 318022 0
Baseline, post-intervention, and 3 and 6 months following the intervention
Secondary outcome [4] 318023 0
Mean score on the UPDRS (motor assessment)
Timepoint [4] 318023 0
Baseline, post-intervention, and 3 and 6 months following the intervention

Eligibility
Key inclusion criteria
Due to significant difficulties recruiting participants who met the DSM-5 criteria for Depressive Disorder the eligibility criteria was broadened to include people who did not meet this criteria and presented with mild to no symptoms of depression. The rest of the inclusion criteria remain the same.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study criteria was changed to include participants on Deep Brain Stimulation.

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
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
Sample size calculations were performed for the primary outcome variable, which is on an intent-to-treat basis, using procedures for determining power for longitudinal designs with attrition. Power analyses assumed a two-tailed alpha of 0.01, 3 assessment points (with baseline serving as a covariate), and attrition rates of 25%. Based on a large effect size (0.8), with .80 power and 2 groups, a minimum sample of 50 participants is required (25 per group). Based on 6-8 participants per group 4 rounds of each group treatment (MBCT or SP) will be required.

The data will be analysed using a GLMM. Participants will be allocated according to a computer-generated algorithm. Generalised linear mixed models (GLMMs) will be conducted in SPSS-V22 to test the hypotheses, which will use all data present at each assessment point thereby reducing subject attrition on power. In the primary and secondary outcomes, a Condition x Time interaction is predicted. Mediation will be tested via the Sobel test.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2016
Actual
15/03/2016
Date of last participant enrolment
Anticipated
1/06/2016
Actual
19/09/2016
Date of last data collection
Anticipated
22/05/2017
Actual
Sample size
Target
50
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4419 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 10631 0
6102 - Bentley
Recruitment postcode(s) [2] 10632 0
6959 - Fremantle

Funding & Sponsors
Funding source category [1] 292156 0
Hospital
Name [1] 292156 0
Fremantle Hospital Medical Research Foundation
Country [1] 292156 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 290831 0
Hospital
Name [1] 290831 0
Fremantle Hospital and Health Service
Address [1] 290831 0
Alma Street, Fremantle, WA, 6959
Country [1] 290831 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293631 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 293631 0
Ethics committee country [1] 293631 0
Australia
Date submitted for ethics approval [1] 293631 0
15/10/2015
Approval date [1] 293631 0
23/11/2015
Ethics approval number [1] 293631 0
Ethics committee name [2] 293632 0
South Metropolitan Health Service (SMHS) Human Research Ethics Committee (HREC)
Ethics committee address [2] 293632 0
Ethics committee country [2] 293632 0
Australia
Date submitted for ethics approval [2] 293632 0
03/11/2015
Approval date [2] 293632 0
08/04/2016
Ethics approval number [2] 293632 0

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

Contacts
Principal investigator
Name 60782 0
Dr Sarah Egan
Address 60782 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley, WA, 6102
Country 60782 0
Australia
Phone 60782 0
61 8 9266 2367
Fax 60782 0
Email 60782 0
[email protected]
Contact person for public queries
Name 60783 0
Caitlin Timms
Address 60783 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley, WA, 6102
Country 60783 0
Australia
Phone 60783 0
61410277969
Fax 60783 0
Email 60783 0
[email protected]
Contact person for scientific queries
Name 60784 0
Sarah Egan
Address 60784 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley, WA, 6102
Country 60784 0
Australia
Phone 60784 0
61 8 9266 2367
Fax 60784 0
Email 60784 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.