Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001531707
Ethics application status
Approved
Date submitted
29/11/2022
Date registered
12/12/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
12/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Parkinson’s disease Getting Out and Active Living (PD-GOAL) program: The effect of behavioural activation therapy on apathy and depression in people with Parkinson’s disease (PD)
Scientific title
The Parkinson’s disease Getting Out and Active Living (PD-GOAL) program: A pilot behavioural activation intervention trial for apathy and depression in Parkinson’s disease (PD)
Secondary ID [1] 308507 0
Nil known
Universal Trial Number (UTN)
U1111-1284-4871
Trial acronym
PD-GOAL
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 328322 0
Depression 328323 0
Apathy 328324 0
Anhedonia 328325 0
Anxiety 328326 0
Quality of Life 328327 0
Carer burden 328328 0
Condition category
Condition code
Neurological 325364 325364 0 0
Parkinson's disease
Mental Health 325365 325365 0 0
Depression
Mental Health 325366 325366 0 0
Anxiety
Mental Health 325437 325437 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will pilot a new psychological intervention, the Parkinson’s disease Getting Out and Active Living (PD-GOAL) program. Participants will be randomly allocated to receive the PD-GOAL program in one of two rounds. Those allocated to the intervention condition will receive the PD-GOAL program in Round 1 while those allocated to the waitlist control condition will receive the PD-GOAL program in Round 2, approximately 2-months later. The intervention will be delivered over a period of 6 weeks in total.

The PD-GOAL program is a 6-session hybrid-telehealth intervention that aims to alleviate symptoms of depression and apathy by identifying and promoting engagement in meaningful and enjoyable activities. The PD-GOAL program is grounded in principles of behavioural activation, an evidence-based, psychological therapeutic approach for depression that has been validated by the American Psychological Association. Together with people living with PD and their support people, the Research Team previously adapted and co-designed the PD-GOAL program to be suitable for people living with PD in Australia. People with PD and their support people were asked to provide their feedback on the design of the study, the delivery mode of the PD-GOAL program, the involvement of support people, and the clarity, appropriateness and design of the program materials. Group discussions were conducted and feedback was provided over three 2-hour workshops, which were delivered over a period of 5 weeks.

As part of the program, an initial group session will take place between the trained program facilitators (i.e., Program Coaches), participants, and their support people (if desired). No more than 10 participants (not including their support people) will attend session 1 either in person or via video call. In this session (1.5-2 hours), participants will learn about (1) mood and motivation changes in PD, (2) the rationale behind the program, (3) tracking their baseline activities and (4) identifying activities that would be enjoyable and important to them. This content will be delivered via PowerPoint slides, short videos, and guided group discussions. Participants will also be provided with two program booklets (a guidebook and workbook). Over the following week, they will be asked to record the activities they currently do each day (i.e., tracking their baseline activities) in the workbook and to reflect on their levels of mood and motivation. They will also be asked to complete a worksheet about the areas of their life they might like to plan activities for (i.e., activities to improve relationships). These between-session workbook tasks are expected to take 15-30 minutes per week to complete, over the 6 weeks of the program.

Over the next 5 weeks, participants will then receive weekly one-to-one calls from their assigned Program Coach who will personalise the program for them. The first call (session 2, 30-45 minutes) will be scheduled for one week after session 1 and will involve discussing participants' baseline activity levels and possible activities that they may be interested in engaging in over the course of the program. One or several activity goals will be selected and scheduled, and the participant will be encouraged to try to complete this activity over the following week. Scheduled activities will be personalised to each participant and their own set of circumstances, abilities, and interests. Over the next four weeks of the program (sessions 3-6), participants will receive weekly ‘check-in’ calls (via phone or video call) from their Program Coach to discuss how they went with their activity goal/s and to schedule activities for the following week. They will also be supported to troubleshoot and overcome barriers to completing these activities. These calls are expected to last for 15-45 minutes; however, the duration will fluctuate from participant to participant depending on their specific experiences and barriers. Participants also have the option of nominating a support person (i.e., spouse, family member, close friend) to learn about the program and support them through it (if desired).

In addition to the weekly calls throughout weeks 2-6 of the program, participants will be asked to read the relevant sections of the guidebook and complete the relevant workbook tasks, which are expected to take approximately 15-30 minutes each week. The time taken to complete the personalised activity goals each week will vary on a participant-to-participant basis. Participants will be encouraged to commit fully to the program and all between-session tasks, but there will be no minimum requirement of time spent.

The PD-GOAL program has been designed specifically for this pilot trial. Further details on the design and content of the program booklets will be provided in the form of a scientific journal article to disseminate the pilot trial findings. Feedback on the acceptability and feasibility of the PD-GOAL program will also be incorporated in future updates to the program booklets. The updated program booklets will be made publicly available upon study completion and any final adjustments.

Program Coaches will hold an Honours degree in psychology. Program Coaches will be trained in program delivery by two of the investigators, (1) a registered Clinical Neuropsychologist with 10 years’ experience in clinical dementia research and (2) a registered Clinical Psychologist with extensive experience employing behavioural activation with clients and who is currently administering a trial of a behavioural activation program to improve engagement and well-being in older adults. Program Coaches will attend multiple training sessions and will be provided with extensive supporting information to assist. The two investigators may also administer some of the sessions and will be on hand to provide supervision when required.

For each week, Program Coaches will refer to the program materials to ensure they cover all the content for that week. They will also ask participants a series of questions during the five weekly calls to record whether or how often participants completed the between session tasks. Answers to these questions will be noted and, with the consent of the participant, their workbook will also be collected and assessed for treatment fidelity.
Intervention code [1] 324944 0
Treatment: Other
Intervention code [2] 324945 0
Lifestyle
Intervention code [3] 324946 0
Behaviour
Comparator / control treatment
The intervention group will be compared with the waitlist control group who will receive the PD-GOAL program approximately 2 months later (in Round 2). Participants in the intervention group will be asked to complete outcome measures at 3 time-points: baseline, immediately post-trial and at a 3-month follow-up. Participants in the waitlist control group will be asked to complete outcome measures at 4 time-points: baseline, pre-trial, immediately post-trial and at a 3-month follow-up. This will enable comparison between the groups.
Control group
Active

Outcomes
Primary outcome [1] 333225 0
Any change in depression scores on the Geriatric Depression Scale (Sheikh & Yesavage, 1986) relative to baseline and to the waitlist control group.
Timepoint [1] 333225 0
Intervention: Baseline (pre-trial), one week (primary endpoint), and 3-months post-intervention completion.
Control: Baseline, approximately 2 months post-baseline (pre-trial), one week (primary endpoint), and 3-months post-intervention completion.
Primary outcome [2] 333226 0
Any change in apathy scores on the Dimensional Apathy Scale (Radakovic & Abrahams, 2014) relative to baseline and to the waitlist control group.
Timepoint [2] 333226 0
Intervention: Baseline (pre-trial), one week (primary endpoint), and 3-months post-intervention completion.
Control: Baseline, approximately 2 months post-baseline (pre-trial), one week (primary endpoint), and 3-months post-intervention completion.
Secondary outcome [1] 416228 0
Any changes in anhedonia scores assessed as a composite of scores on The Snaith-Hamilton Pleasure Scale (Snaith et al., 1995) and The Temporal Pleasure Scale (Gard et al., 2006) relative to baseline and the waitlist control group.
Timepoint [1] 416228 0
Intervention: Baseline (pre-trial), one week and 3-months post-intervention completion.
Control: Baseline, approximately 2-months post-baseline (pre-trial), one week and 3 months post-intervention.
Secondary outcome [2] 416229 0
Any changes in anxiety scores on The Parkinson’s Anxiety Scale (Leentjens et al., 2014) relative to baseline and the waitlist control group.
Timepoint [2] 416229 0
Intervention: Baseline (pre-trial), one week and 3-months post-intervention completion.
Control: Baseline, approximately 2-months post-baseline (pre-trial), one week and 3 months post-intervention.
Secondary outcome [3] 416230 0
Any changes in quality-of-life scores on The Parkinson’s Disease Questionnaire (Peto et al., 1995) relative to baseline and the waitlist control group.
Timepoint [3] 416230 0
Intervention: Baseline (pre-trial), one week and 3-months post-intervention completion.
Control: Baseline, approximately 2-months post-baseline (pre-trial), one week and 3 months post-intervention.
Secondary outcome [4] 416231 0
Any changes in PD-symptom severity scores on the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Patient Questionnaire relative to baseline and the waitlist control group.
Timepoint [4] 416231 0
Intervention: Baseline (pre-trial), one week and 3-months post-intervention completion.
Control: Baseline, approximately 2-months post-baseline (pre-trial), one week and 3 months post-intervention.
Secondary outcome [5] 416232 0
Support people (i.e., spouse, family member, close friend) will complete the Zarit Caregiver Burden Scale (Zarit et al., 1980). Any changes in carer burden scores will be assessed relative to baseline and to support people in the waitlist control group.
Timepoint [5] 416232 0
Intervention: Baseline (pre-trial), one week and 3-months post-intervention completion.
Control: Baseline, approximately 2-months post-baseline (pre-trial), one week and 3 months post-intervention.
Secondary outcome [6] 416233 0
Analysis of the acceptability of the PD-GOAL program via the administration of an Acceptability Questionnaire (Sekhon et al., 2017).
Timepoint [6] 416233 0
One week and three months post-intervention completion to capture the acceptability of the program overtime.
Secondary outcome [7] 416234 0
Qualitative interview data from participants asking them about their experiences of and feedback on the PD-GOAL program. Semi-structured interviews will be conducted by a member of the research team by phone or video call (participants' preference) using a study-specific questionnaire. The interview is expected to take 30 minutes and will be audio-recorded (via phone) or video-recorded (via video call).
Timepoint [7] 416234 0
One week and three months post-intervention completion to capture thoughts on the program over time.

Eligibility
Key inclusion criteria
Adults with Parkinson’s disease (without dementia or severe cognitive impairment) who score:
1. 8 and above on the depression subscale of The Hospital Anxiety and
Depression Scale (Zigmond & Snaith et al., 1983) and/or
2. 35 and above on the Apathy Evaluation Scale (Marin et al., 1991).
3. 16 and above on the MoCA-Blind (Nasreddine et al., 2005).

A support person must be an adult (18 years or over) who:
1. Knows the person with PD well (i.e., is a spouse, family member or friend).
2. Can speak English fluently.
3. Is able to and available to provide support throughout the program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to participate in the program due to language or hearing difficulties, no access to phone or a computer with internet, is currently receiving psychotherapy from a psychologist and/or cannot commit to participating in the dates scheduled for Round 1 or 2 of the program.

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 not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be randomly allocated to receive the PD-GOAL program in one of two rounds. Those allocated to the intervention condition will receive the PD-GOAL program in Round 1 while those allocated to the waitlist control condition will receive the PD-GOAL program in Round 2, approximately 2-months later.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this study aims to pilot the newly adapted PD-GOAL program, a small sample of 20 participants will be recruited (n = 10 PD-GOAL program group, n = 10, waitlist control group). Quantitative process evaluations from this study will provide valuable pilot data on effect sizes and will inform power calculations for future larger scale trials.
Quantitative outcomes will be assessed using repeated-measures ANOVAs and t-tests (or non-parametric equivalents), and correlational analyses using Pearson Correlations. Data regarding intervention fidelity and burden (i.e., dropout rates) will also be analysed. Qualitative interviews will be transcribed and evaluated through thematic analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
1/02/2023
Date of last participant enrolment
Anticipated
1/03/2023
Actual
2/10/2023
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312747 0
Charities/Societies/Foundations
Name [1] 312747 0
Breakthrough Mental Health Research Foundation
Country [1] 312747 0
Australia
Funding source category [2] 312751 0
University
Name [2] 312751 0
Flinders University Institute for Mental Health and Wellbeing
Country [2] 312751 0
Australia
Primary sponsor type
Individual
Name
Dr Stephanie Wong
Address
College of Education, Psychology and Social Work, Flinders University, Sturt Rd Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 314368 0
Individual
Name [1] 314368 0
Associate Professor Tim Windsor
Address [1] 314368 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd Bedford Park SA 5042
Country [1] 314368 0
Australia
Secondary sponsor category [2] 314373 0
Individual
Name [2] 314373 0
Dr Monica Cations
Address [2] 314373 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd Bedford Park SA 5042
Country [2] 314373 0
Australia
Secondary sponsor category [3] 314374 0
Individual
Name [3] 314374 0
Associate Professor Trevor Mazzucchelli
Address [3] 314374 0
School of Psychology, Curtin University, Kent St, Bentley WA 6102
Country [3] 314374 0
Australia
Secondary sponsor category [4] 314375 0
Individual
Name [4] 314375 0
Dr Julia Scott
Address [4] 314375 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd Bedford Park SA 5042
Country [4] 314375 0
Australia
Secondary sponsor category [5] 314376 0
Individual
Name [5] 314376 0
Olivia Nassaris
Address [5] 314376 0
The Hospital Research Foundation – Parkinson’s, 25 King William Road, Unley SA 5061
Country [5] 314376 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312051 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 312051 0
Ethics committee country [1] 312051 0
Australia
Date submitted for ethics approval [1] 312051 0
27/10/2022
Approval date [1] 312051 0
19/12/2022
Ethics approval number [1] 312051 0
SAC HREC Reference Number: 2022/HRE00242

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

Contacts
Principal investigator
Name 123282 0
Dr Stephanie Wong
Address 123282 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd Bedford Park SA 5042
Country 123282 0
Australia
Phone 123282 0
+61 8 7221 8448
Fax 123282 0
Email 123282 0
[email protected]
Contact person for public queries
Name 123283 0
Stephanie Wong
Address 123283 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd Bedford Park SA 5042
Country 123283 0
Australia
Phone 123283 0
+61 8 7221 8448
Fax 123283 0
Email 123283 0
[email protected]
Contact person for scientific queries
Name 123284 0
Stephanie Wong
Address 123284 0
College of Education, Psychology and Social Work, Flinders University, Sturt Rd Bedford Park SA 5042
Country 123284 0
Australia
Phone 123284 0
+61 8 7221 8448
Fax 123284 0
Email 123284 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data collected from participants during the trial. Participants must consent to the sharing of their de-identified data by ticking the relevant box on the consent form.
When will data be available (start and end dates)?
Within 12 months of publications arising from the project. No end date determined.
Available to whom?
De-identified data will be made available to other researchers upon reasonable request provided that they have gained separate ethics approval. Those who request access must agree to comply with ethics requirements regarding data storage and access.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Email Principal Investigator ([email protected])


What supporting documents are/will be available?




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.