Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001487707
Ethics application status
Approved
Date submitted
11/10/2022
Date registered
28/11/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
28/11/2022
Date results information initially provided
28/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Symptomatic Relief of Treatment Resistant Depression via Group Dance Therapy Sessions with Adults
Scientific title
Understanding the Effect/s of Group Dance Therapy Sessions on Symptomatic Relief of Treatment Resistant Depression in Adults
Secondary ID [1] 308163 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression. 327882 0
The lived experience of stress in treatment resistant depression. 327883 0
Condition category
Condition code
Mental Health 324968 324968 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dance Therapy is a relational-somatic practice that utilises aspects of therapeutic movement movement along with the principles of group psychotherapy.
- The intervention will be facilitated once a week for for 12 weeks.
- Each session will be 45 minutes long. This 45-minute period will include: 10 minutes of warm-up, 15 minutes of movement development (i,e., use of mirroring, active imagination, use of metaphors, and group rhythmic movement), followed by 10 minutes of gentle stretching as the cool down activity, and finally ending with a 10 minute verbal brief.
- The mode of facilitation will be face to face in a group setting. Each group will include a group of approx. 5 individuals with treatment resistant depression. The researchers aims to recruit two groups (of 5 individuals in each).
- Participants are not expected to participate in any therapeutic activities at home. No movement exercises will be prescribed.
- The frequency and duration of the intervention dose will be consistent across both groups. Session attendance will be taken to track participant's participation. Participants will be asked to log the date and time of the hair samples (that they will collect at their respective homes). Standardised sample kits (ziplocks with a coded sticker inside an opaque envelope) will be provided to each participant.
Intervention code [1] 324607 0
Treatment: Other
Intervention code [2] 324609 0
Lifestyle
Comparator / control treatment
There is no comparator or controlled group in this study. The study is a pre-post intervention study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332767 0
Any change in stress levels (assessed via cortisol analysis of the hair samples) is the primary outcome of this study.
Timepoint [1] 332767 0
Data on stress levels will be collected at three time points, that is on weeks 6, 12, and 16 for each participant; these time-points refer to the time period after the study intervention has commenced.
Primary outcome [2] 332768 0
Any change in depression levels (assessed via the Hamilton Depression Rating Scale scores) will also be considered a primary outcome of this study.
Timepoint [2] 332768 0
Data on depression levels will be measured by comparing data collected on weeks 0, 8, and 16 for each participant; these timepoints refer to the time period after the study intervention has commenced.
Secondary outcome [1] 415910 0
There are no secondary outcomes in this research study. There are two outcomes of interest in this study (depression and stress levels); both of which are primary outcomes.
Timepoint [1] 415910 0
There are no secondary outcomes in this research study. There are two outcomes of interest in this study (depression and stress levels); both of which are primary outcomes.

Eligibility
Key inclusion criteria
Adults (between 18-50 yrs of age) who have a diagnosis of clinical depression which has either lasted at least 18 months OR have been identified to have ‘treatment resistance’ by a medical professional
Have not experienced a significant reduction in symptoms despite trying at least two-cycles of anti-depressants.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Persons who have an illness that requires urgent and persistent medical care.
Persons who are at risk of active self-harm or are a fall risk.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This research project has a pre-post mixed-method comparative design study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The quantitative data collected in this research study will be analyzed statistically using analysis of variance (ANOVA) for repeated measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2022
Actual
1/03/2023
Date of last participant enrolment
Anticipated
Actual
15/05/2023
Date of last data collection
Anticipated
Actual
8/08/2023
Sample size
Target
10
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38740 0
3000 - Melbourne
Recruitment postcode(s) [2] 38741 0
3006 - Southbank

Funding & Sponsors
Funding source category [1] 312421 0
University
Name [1] 312421 0
University of Melbourne
Country [1] 312421 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
234 St Kilda Rd, Southbank
VIC 3006,
Australia.
Country
Australia
Secondary sponsor category [1] 313994 0
None
Name [1] 313994 0
None
Address [1] 313994 0
None
Country [1] 313994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311766 0
University of Melbourne, Humanities, Arts and Social Sciences (HASS1) - Greater Than Low Risk (GTLR) committee
Ethics committee address [1] 311766 0
Office of Research Ethics and Integrity (OREI)
Located in The University of Melbourne
1/21 Bedford St, North Melbourne VIC 3051
Ethics committee country [1] 311766 0
Australia
Date submitted for ethics approval [1] 311766 0
11/09/2022
Approval date [1] 311766 0
28/02/2023
Ethics approval number [1] 311766 0
In progress. Application ID: 24580

Summary
Brief summary
Individuals living with treatment resistant depression are faced with an especially challenging road to recovery. The factors that complicate treatment include, lack of a universal definition on what treatment resistant depression is, poor doctor-patient relationship, inadequate knowledge about treatment options, patient /caregiver fatigue, and high cost associated with co-morbidities.

Due to the nature of treatment resistant depression, a need to emotionally self-regulate amidst stress commonly arises in adults. This stress may range from activities of daily living (like bathing, taking medication, grocery shopping) to medical management (attending doctor’s appointment, corresponding with insurance providers etc.) and/or social engagements. Continuous exposure to such stress keeps one’s sympathetic nervous system charged and activated often resulting in a heightened state of alarm which further exasperates depressive symptoms. In this way, repeated exposure to stress is part of the lived experience in adults with treatment resistant depression.

This graduate researcher believes that moving towards stability begins with an increased understanding and awareness about one’s automatic stress responses. Such knowledge can help foster and create a path where individuals living with treatment resistant depression can comfortably identify manage their stress.

Current tools in depression treatment do not document the experience of learning and practicing somatic based stress management techniques after participating in group dance therapy sessions. This tool may be potentially helpful for both, adults living with TRD and their health practitioners in tracking symptoms of TRD.

Based on this background, this research project is designed as to help understand if group dance therapy sessions may be helpful in alleviating stress associated with a treatment resistant depression diagnosis by fostering somatic aptitude in participants and if dance therapy helps provide any symptomatic relief associated with treatment resistant depression.
Trial website
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 122294 0
Ms Neha Christopher
Address 122294 0
University of Melbourne
Creative Arts Therapy Research Unit
234 St Kilda Rd, Southbank VIC 3006
Country 122294 0
Australia
Phone 122294 0
+61 451158770
Fax 122294 0
Email 122294 0
n.christopher@unimelb.edu.au
Contact person for public queries
Name 122295 0
Ms Neha Christopher
Address 122295 0
University of Melbourne
Creative Arts Therapy Research Unit
234 St Kilda Rd, Southbank VIC 3006
Country 122295 0
Australia
Phone 122295 0
+61 3 9035 5511
Fax 122295 0
Email 122295 0
n.christopher@unimelb.edu.au
Contact person for scientific queries
Name 122296 0
Ms Neha Christopher
Address 122296 0
University of Melbourne
Creative Arts Therapy Research Unit
234 St Kilda Rd, Southbank VIC 3006
Country 122296 0
Australia
Phone 122296 0
+61 3 9035 5511
Fax 122296 0
Email 122296 0
n.christopher@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing individuals participant data is not congruent with the research design and consent forms if this study.


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.