ANZCTR - Registration

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Treatment Resistant Depression.

The lived experience of stress in treatment resistant depression.

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

Any change in stress levels (assessed via cortisol analysis of the hair samples) is the primary outcome of this study.

Timepoint [1]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3000 - Melbourne

Recruitment postcode(s) [2]

3006 - Southbank

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Melbourne

Address [1]

The University of Melbourne
Grattan Street, Parkville,
Victoria, 3010,
Australia.

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne, Humanities, Arts and Social Sciences (HASS1) - Greater Than Low Risk (GTLR) committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

11/09/2022

Approval date [1]

28/02/2023

Ethics approval number [1]

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

Ms Neha Christopher

Address

University of Melbourne
Creative Arts Therapy Research Unit
234 St Kilda Rd, Southbank VIC 3006

Country

Australia

Phone

+61 451158770

Fax

n.christopher@unimelb.edu.au

Contact person for public queries

Name

Neha Christopher

Address

University of Melbourne
Creative Arts Therapy Research Unit
234 St Kilda Rd, Southbank VIC 3006

Country

Australia

Phone

+61 3 9035 5511

Fax

n.christopher@unimelb.edu.au

Contact person for scientific queries

Name

Neha Christopher

Address

University of Melbourne
Creative Arts Therapy Research Unit
234 St Kilda Rd, Southbank VIC 3006

Country

Australia

Phone

+61 3 9035 5511

Fax

n.christopher@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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