Depressive DisorderNCT02675712
Effect of African Drumming in Mood Disorders
An observational study of Depressive Disorder and Bipolar Disorder, run by University of Stellenbosch.
Trial summary
This pilot study evaluated whether participating in an African drumming activity for 45 minutes immediately improved mental well-being among 13 adults diagnosed with acute mood disorders who were attending a private mental health clinic. The drumming intervention was completed by occupational therapists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Bipolar Disorder
- What is being tested?
- African drumming
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 13 adults diagnosed with a mood disorder (by their own physician), aged 33 to 69 years (M = 45.38, SD = 11.48). The population included both women (n = 10) and men (n = 3). Almost half the participants were of Mixed Ethnicity (n = 6), while the remaining participants were White (n = 7).
Who may be able to join
- Attending mental health clinic
- Diagnosed mood disorder
- Voluntarily attending drumming group
Who cannot join
- Psychosis
About this study
Official title: The Effect of African Drumming on on Mental Well-being Among Adults With Acute Mood Disorder
This pilot study evaluated whether participating in an African drumming activity for 45 minutes immediately improved mental well-being among 13 adults diagnosed with acute mood disorders who were attending a private mental health clinic. The drumming intervention was completed by occupational therapists.
Read the detailed description
This pilot study evaluated the effectiveness of an occupational therapy-led African drumming group on mental well-being among adult psychiatric inpatients with mood disorders. A secondary purpose was to test a protocol for the delivery of African drumming interventions to adults with acute mood disorders.
A quasi-experimental uncontrolled one-group pre-test-post-test design was used to collect data during six drumming groups at an acute mental health clinic. Thirteen adults completed assessments of different aspects of mental well-being, including mood and enjoyment, before and after the intervention. Because this was a pilot study, participants were not assigned to any comparison groups. In addition, in-patients at the clinic received the intervention whether they participated in the study or not.
Improvement in mental well-being across different domains of mental well-being was expected, including feelings of anger, tension, confusion, depression, fatigue and vigour. The researchers also expected the intervention to be more effective in participants with previous drumming experience, and in those with lower levels of anxiety and depression.
- Conditions
- Depressive Disorder, Bipolar Disorder
- Being tested
- African drumming
- Medical subject headings
- Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
African drummingOther
Also called Drumming
Rhythmic beating or tapping of a variety of percussion instruments, which often occurs within a group setting
| Study group | Role | What they receive |
|---|---|---|
| Adults with acute mood disorders | Adults aged over 18 diagnosed with an acute episode of a mood disorder using DSM-V criteria Receives: Other: African drumming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stellenbosch Mood Scale (STEMS)
Change from baseline in Stellenbosch Mood Scale at 45 minutes
Measured: Baseline and 45 minutes
Secondary outcomes (3)
Generalised Anxiety Disorder - 7 scale (GAD-7)
Level of anxiety as measured by a 7-item self-report Likert-type scale
Measured: Baseline
Primary Health Questionnaire - 9 (PHQ-9)
Level of depression as measured by a 9-item self-report Likert-type scale
Measured: Baseline
Enjoyment of Interaction Scale
Enjoyment of the intervention as measured by a 4-item self-report Likert-type scale
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nicola Plastow, University of Stellenbosch
- Investigators
- Nicola A Plastow, PhD, Principal investigator, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675712
- Sponsor's protocol ID
- S15/02/022
- Status last verified
- Feb 2016
- First submitted
- 20 Jan 2016
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of African Drumming on on Mental Well-being Among Adults With Acute Mood Disorder
- ClinicalTrials.gov ID
- NCT02675712
- Acronym / sponsor ID
- S15/02/022
- Conditions
- Depressive Disorder, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Feb 2016 (estimated)
- 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 pilot study evaluated whether participating in an African drumming activity for 45 minutes immediately improved mental well-being among 13 adults diagnosed with acute mood disorders who were attending a private mental health clinic. The drumming intervention was completed by occupational therapists.
Detailed description
This pilot study evaluated the effectiveness of an occupational therapy-led African drumming group on mental well-being among adult psychiatric inpatients with mood disorders. A secondary purpose was to test a protocol for the delivery of African drumming interventions to adults with acute mood disorders.
A quasi-experimental uncontrolled one-group pre-test-post-test design was used to collect data during six drumming groups at an acute mental health clinic. Thirteen adults completed assessments of different aspects of mental well-being, including mood and enjoyment, before and after the intervention. Because this was a pilot study, participants were not assigned to any comparison groups. In addition, in-patients at the clinic received the intervention whether they participated in the study or not.
Improvement in mental well-being across different domains of mental well-being was expected, including feelings of anger, tension, confusion, depression, fatigue and vigour. The researchers also expected the intervention to be more effective in participants with previous drumming experience, and in those with lower levels of anxiety and depression.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with acute mood disorders | – | Other: African drummingAdults aged over 18 diagnosed with an acute episode of a mood disorder using DSM-V criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 13 adults diagnosed with a mood disorder (by their own physician), aged 33 to 69 years (M = 45.38, SD = 11.48). The population included both women (n = 10) and men (n = 3). Almost half the participants were of Mixed Ethnicity (n = 6), while the remaining participants were White (n = 7).
Key inclusion criteria (3 listed)
- Attending mental health clinic
- Diagnosed mood disorder
- Voluntarily attending drumming group
Key exclusion criteria (1 listed)
- Psychosis
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 |
|---|---|---|
| African drummingAlso: DrummingRhythmic beating or tapping of a variety of percussion instruments, which often occurs within a group setting | Other | Adults with acute mood disorders |
Primary outcome
Stellenbosch Mood Scale (STEMS)
Time frame: Baseline and 45 minutes
Change from baseline in Stellenbosch Mood Scale at 45 minutes
3 secondary outcomes
Generalised Anxiety Disorder - 7 scale (GAD-7)
Time frame: Baseline
Primary Health Questionnaire - 9 (PHQ-9)
Time frame: Baseline
Enjoyment of Interaction Scale
Time frame: 45 minutes
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 5 Feb 2016.
- 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.
Nicola A Plastow, PhD principal investigator
University of Stellenbosch
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Bipolar Disorder, run by University of Stellenbosch.
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 3 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 5 Feb 2016. 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?
Stellenbosch Mood Scale (STEMS) (time frame: Baseline and 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2016.