DepressionNCT04421651
Dance Movement Therapy in the Treatment of Depressed Patients: A Randomised Controlled Trial
A study testing Dance Movement Therapy group in people with Depression, run by University of Jyvaskyla.
Trial summary
This multi-centre research investigates the effects of dance movement therapy (DMT) on participants diagnosed with depression. In total, 109 persons participated in the study in various locations in Finland. All participants received treatment as usual (TAU). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Dance Movement Therapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
This multi-centre research investigates the effects of dance movement therapy (DMT) on participants diagnosed with depression. In total, 109 persons participated in the study in various locations in Finland. All participants received treatment as usual (TAU). They were randomised into DMT + TAU (n = 52) or TAU-only (n = 57). The participants in the DMT + TAU group were offered 20 DMT sessions twice a week for 10 weeks in addition to standard care. The measurement points included pre-treatment measurement at the baseline and post-treatment measurement at the end of the intervention, which was 10 weeks after the pre-treatment measurement. The follow-up measurement was 3 months after the post-treatment measurement. The effects of the intervention were assessed with a clinical measure of depression (BDI-I) and with indicators of physical and psychological distress (CORE-OM and SCL-90). The participants in the treatment group (DMT+TAU) were compared to the participants in the control group who received TAU-only.
Read the 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.
- Conditions
- Depression
- Being tested
- Dance Movement Therapy group
- Keywords
- Dance Movement Therapy, Adults, Depression, Beck Depression Inventory, Clinical Outcomes in Routine Evaluation - Outcome Measure, The Symptoms Check List-90
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Movement Therapy groupBehavioural
DMT-intervention was facilitated by a dance movement therapist and included 20 x 75 mins sessions within 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The participants in the treatment group were offered 20 Dance movement therapy sessions in addition to standard care. Receives: Behavioral: Dance Movement Therapy group |
| Control group | No intervention | Participants in the control group continued treatment as usual in the health services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline depressive symptoms (Beck Depression Inventory; BDI) at 10-week post-treatment measurement
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.
Measured: 10 weeks
Change from post-treatment depressive symptoms (Beck Depression Inventory; BDI) at three-month follow-up measurement
The change in depressive symptoms between the post-treatment measurement at the end of the 10-week intervention and the 3-month follow-up.
Measured: 3 months
Secondary outcomes (4)
Change from baseline psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at 10-week post-treatment measurement
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.
Measured: 10 weeks
Change from post-treatment psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at three-month follow-up measurement
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.
Measured: 3 months
Change from baseline physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at 10-week post-treatment measurement
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).
Measured: 10 weeks
Change from post-treatment physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at three-month follow-up measurement
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jan 2017
- Primary completion1 Oct 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- The Social Insurance Institution of Finland, Finnish Dance Therapy Association
- Responsible party
- Sponsor
- Investigators
- Raimo Lappalainen, Professor, Principal investigator, University of Jyvaskyla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421651
- Sponsor's protocol ID
- UJyvaskyla DMT trial
- Status last verified
- Jun 2020
- First submitted
- 25 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hyvonen K, Pylvanainen P, Muotka J, Lappalainen R. The Effects of Dance Movement Therapy in the Treatment of Depression: A Multicenter, Randomized Controlled Trial in Finland. Front Psychol. 2020 Aug 12;11:1687. doi: 10.3389/fpsyg.2020.01687. eCollection 2020.
PubMed 32903394
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dance Movement Therapy in the Treatment of Depressed Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04421651
- Acronym / sponsor ID
- UJyvaskyla DMT trial
- Conditions
- Depression
- Keywords
- Dance Movement Therapy, Adults, Depression, Beck Depression Inventory, Clinical Outcomes in Routine Evaluation - Outcome Measure, The Symptoms Check List-90
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- The Social Insurance Institution of Finland, Finnish Dance Therapy Association
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-centre research investigates the effects of dance movement therapy (DMT) on participants diagnosed with depression. In total, 109 persons participated in the study in various locations in Finland. All participants received treatment as usual (TAU). They were randomised into DMT + TAU (n = 52) or TAU-only (n = 57). The participants in the DMT + TAU group were offered 20 DMT sessions twice a week for 10 weeks in addition to standard care. The measurement points included pre-treatment measurement at the baseline and post-treatment measurement at the end of the intervention, which was 10 weeks after the pre-treatment measurement. The follow-up measurement was 3 months after the post-treatment measurement. The effects of the intervention were assessed with a clinical measure of depression (BDI-I) and with indicators of physical and psychological distress (CORE-OM and SCL-90). The participants in the treatment group (DMT+TAU) were compared to the participants in the control group who received TAU-only.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Dance Movement Therapy groupThe participants in the treatment group were offered 20 Dance movement therapy sessions in addition to standard care. |
| Control group | No intervention | –Participants in the control group continued treatment as usual in the health services. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance Movement Therapy groupDMT-intervention was facilitated by a dance movement therapist and included 20 x 75 mins sessions within 10 weeks. | Behavioural | Treatment group |
Primary outcome
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.
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.
4 secondary outcomes
Change from baseline psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at 10-week post-treatment measurement
Time frame: 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
Change from baseline physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at 10-week post-treatment measurement
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 32903394Hyvonen K, Pylvanainen P, Muotka J, Lappalainen R. The Effects of Dance Movement Therapy in the Treatment of Depression: A Multicenter, Randomized Controlled Trial in Finland. Front Psychol. 2020 Aug 12;11:1687. doi: 10.3389/fpsyg.2020.01687. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raimo Lappalainen, Professor principal investigator
University of Jyvaskyla
Questions about this trial
What is this clinical trial studying?
A study testing Dance Movement Therapy group in people with Depression, run by University of Jyvaskyla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline depressive symptoms (Beck Depression Inventory; BDI) at 10-week post-treatment measurement (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.