- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421651
Dance Movement Therapy in the Treatment of Depressed Patients: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research investigates the outcomes of dance movement therapy (DMT) groups in the treatment of adults with depression. In total, 157 participants were involved. Of them, 109 were randomized into DMT group (n = 52) or control group (n = 57). The rest of the participants participated in non-randomized DMT groups. All participants met the criteria for the eligibility for rehabilitation psychotherapy, had depression diagnosed by a doctor, and the severity of depression threatened the ability to work/ study. All participants received treatment as usual during the research. DMT-intervention was facilitated by a dance movement therapist and included 20 x 75 mins sessions within 10 weeks. Depressive symptoms (BDI), physical and psychological distress (CORE-OM, SCL-90), ability to work/study, and body image were assessed at three measurement points: pre-measurement at the baseline, post-measurement 10 weeks after the pre-treatment measurement, and a follow-up measurement three months after the post-treatment measurement.
This research includes a larger number of participants (N = 109) than have been involved in previous studies utilising randomised controlled trials in research designs. The research generates further information about the effectiveness of dance movement therapy groups in the rehabilitation of depression as it was conducted in five cities across Finland. This type of multi-centre research can provide a realistic picture of the typical practice of a range of dance movement therapists working with participants in various geographic locations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The participant needed to have a diagnoses of depression by a psychiatrist or general practitioner (ICD -diagnostic system). The researchers checked that the participants were working age (18-65 years of age) and fulfilled the criteria for rehabilitative psychotherapy in Finland: at least three months of relevant treatment since depression was diagnosed; the participants' ability to work or study is impaired by depression; a psychiatrist has determined that rehabilitative psychotherapy is necessary to improve or support the participant's ability to work or study.
Exclusion Criteria:
- active suicidal ideation; psychotic symptoms; substance misuse that is on a critical level. Also, interviewees who had pain-related problems that restricted daily life or were pregnant were not admitted to the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment group
The participants in the treatment group were offered 20 Dance movement therapy sessions in addition to standard care.
|
DMT-intervention was facilitated by a dance movement therapist and included 20 x 75 mins sessions within 10 weeks.
|
NO_INTERVENTION: Control group
Participants in the control group continued treatment as usual in the health services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline depressive symptoms (Beck Depression Inventory; BDI) at 10-week post-treatment measurement
Time Frame: 10 weeks
|
BDI measures depressive symptoms with 21 items.
Each item is scored 0-3 and sum scores are calculated on the basis of participants' responses.
The total sum score can range from 0 to 63.
|
10 weeks
|
Change from post-treatment depressive symptoms (Beck Depression Inventory; BDI) at three-month follow-up measurement
Time Frame: 3 months
|
The change in depressive symptoms between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at 10-week post-treatment measurement
Time Frame: 10 weeks
|
The CORE-OM comprises 43 items and four dimensions of well-being, problems, life functioning, and risk for aggressive/suicidal behaviour.
Each item is scored from 0 to 4. CORE-OM items are summed and then divided by the number of answered items, which is then multiplied by ten; that is, the total scores ranges from 0 to 40.
|
10 weeks
|
Change from post-treatment psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at three-month follow-up measurement
Time Frame: 3 months
|
The change in psychological distress (CORE-OM) between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.
|
3 months
|
Change from baseline physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at 10-week post-treatment measurement
Time Frame: 10 weeks
|
SCL-90 uses 90 items to measure nine primary symptomatic dimensions, including somatisation, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism.
The level of distress is scored on a scale from 0 to 4. An average score of the 90 items is calculated, which represents the severity of the participant's symptoms, that is, the Global Severity Index (GSI).
|
10 weeks
|
Change from post-treatment physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at three-month follow-up measurement
Time Frame: 3 months
|
The change in physiological and psychological symptoms (SCL-90) between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raimo Lappalainen, Professor, University of Jyväskylä
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UJyvaskyla DMT trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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