Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000709145
Ethics application status
Approved
Date submitted
11/04/2019
Date registered
13/05/2019
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Self-Compassion Group Intervention for Patients Living with Chronic Medical Illness: Treatment Development and Feasibility Study
Scientific title
A Self-Compassion Group Intervention for Patients Living with Chronic Medical Illness: Treatment Development and Feasibility Study
Secondary ID [1] 297957 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Medical Illness 312353 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310913 310913 0 0
Occupational therapy
Mental Health 311155 311155 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was a four-week group self-compassion-based intervention, designed to improve self-report and biological markers of well-being in midlife and older adult patients living with chronic illness. Participants attended a one-hour face to face group self-compassion-based intervention once per week for four weeks. The intervention was delivered by healthcare professionals (clinical psychologist and occupational therapist). The overarching theme of the intervention was self-compassion.

Each week explored a different facet of self-compassion including mindfulness (week 1), loving-kindness (week 2), self-compassion for the body and mind (week 3) and a concluding integration week + gratitude (week 4). To maintain fidelity, clinicians followed a course manual, including course content, discussion points and self-compassion related meditation scripts.

Feasibility was assessed on six domains. Measures of well-being and heart rate variability (HRV), an index of nervous system functioning, were also collected. The intervention took place at a private rehabiliation hospital (The North Eastern Rehabilitation Centre).

Intervention code [1] 314178 0
Lifestyle
Intervention code [2] 314436 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319736 0
The primary outcome is feasibility, a composite outcome with six domains.

Recruitment: A recruitment rate of approximately four participants per month over two months was deemed to be feasible, resulting in a total expected sample size of approximately 8 participants. Recruitment was measured through number of informed consent forms signed.

Adherence: An adherence rate of at least 65% (i.e. that participants attend an average of 2.6 out of 4 sessions) was expected, to indicate feasibility of adherence. Attendance was measured using session attendance checklists.

3. Acceptability: A satisfaction rating of at least 5/7 was deemed to indicate acceptability of the intervention. Satisfaction was measured using a 1-item rating of course satisfaction measured on a 7-point likert scale.

4. Attrition: We defined an attrition rate of less than or equal to 15% as indicating feasibility, given this rate has been used in comparable research of older adults with physical conditions (Blandy, Beevers, Fitzmaurice, & Morris, 2015).

5. Safety:Any adverse events symptoms were documented at each session. Self-compassion training is a low risk psychological intervention with no known risks and so no specific adverse events were expected. It is, however, possible that some participants might be distressed by the process of self-reflection but this risk was minimised by the intervention being conducted by a qualified clinical psychologist. Any participant distress was recorded in writing.

6: Data collection: Feasible ECG data collection was pre-specified as requiring that at least 80% of ECG data collected would be fit for analysis. A reason to exclude data could be the presence of irregular heartbeats.
Timepoint [1] 319736 0
Post-intervention (on completion of the 4-week intervention)
Secondary outcome [1] 369344 0
Change in depressive symptoms (measured with the CES-D)
Timepoint [1] 369344 0
Post-intervention (on completion of the 4-week intervention)
Secondary outcome [2] 369345 0
Change in heart rate variability (measured using an ECG)
Timepoint [2] 369345 0
Post-intervention (on completion of the 4-week intervention)
Secondary outcome [3] 369908 0
Change in Self-compassion (measured with the self-compassion scale)
Timepoint [3] 369908 0
Post-intervention (on completion of the 4-week intervention)
Secondary outcome [4] 369909 0
Change in Positive affect (measured with the positive and negative affect schedule)
Timepoint [4] 369909 0
Post-intervention (on completion of the 4-week intervention)
Secondary outcome [5] 369910 0
Change in satisfaction with life (measured with the satisfaction with life scale)
Timepoint [5] 369910 0
Post-intervention (on completion of the 4-week intervention)

Eligibility
Key inclusion criteria
Eligibility criteria included i) being a North Eastern Rehabilitation Centre patient currently in treatment for a chronic medical condition, ii) age 40 and over, and iii) permission to participate from the treating physician.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included i) a lack of conversational English, ii) presence of psychotic symptoms, and iii) a diagnosis of cognitive decline based on discussion with the treatment team.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2017
Date of last participant enrolment
Anticipated
Actual
12/03/2018
Date of last data collection
Anticipated
Actual
9/04/2018
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13610 0
North Eastern Rehabilitation Centre - Ivanhoe
Recruitment postcode(s) [1] 26272 0
3079 - Ivanhoe

Funding & Sponsors
Funding source category [1] 302477 0
University
Name [1] 302477 0
University of Melbourne
Country [1] 302477 0
Australia
Primary sponsor type
University
Name
Hallmark Aging Research Initiative, University of Melbourne
Address
Hallmark Aging Research Initiative, University of Melbourne, Parkville, VIC 3010, Australia
Country
Australia
Secondary sponsor category [1] 302375 0
None
Name [1] 302375 0
NA
Address [1] 302375 0
NA
Country [1] 302375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303139 0
The Melbourne Clinic Research Ethics Committee
Ethics committee address [1] 303139 0
Ethics committee country [1] 303139 0
Australia
Date submitted for ethics approval [1] 303139 0
03/10/2016
Approval date [1] 303139 0
14/11/2016
Ethics approval number [1] 303139 0
TMC 285

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

Contacts
Principal investigator
Name 92606 0
A/Prof Christina Bryant
Address 92606 0
Melbourne School of Psychological Sciences, Redmond Barry Building, University of Melbourne, Parkville, VIC 3010
Country 92606 0
Australia
Phone 92606 0
+61 3 9035 5921
Fax 92606 0
Email 92606 0
[email protected]
Contact person for public queries
Name 92607 0
Christina Bryant
Address 92607 0
Melbourne School of Psychological Sciences, Redmond Barry Building, University of Melbourne, Parkville, VIC 3010
Country 92607 0
Australia
Phone 92607 0
+61 3 9035 5921
Fax 92607 0
Email 92607 0
[email protected]
Contact person for scientific queries
Name 92608 0
Christina Bryant
Address 92608 0
Melbourne School of Psychological Sciences, Redmond Barry Building, University of Melbourne, Parkville, VIC 3010
Country 92608 0
Australia
Phone 92608 0
+61 3 9035 5921
Fax 92608 0
Email 92608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseA Self-Compassion Group Intervention for Patients Living With Chronic Medical Illness: Treatment Development and Feasibility Study.2019https://dx.doi.org/10.4088/PCC.19m02470
N.B. These documents automatically identified may not have been verified by the study sponsor.