NCT02675712

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

January 20, 2016

Last Update Submit

February 4, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stellenbosch Mood Scale (STEMS)

    Change from baseline in Stellenbosch Mood Scale at 45 minutes

    Baseline and 45 minutes

Secondary Outcomes (3)

  • Generalised Anxiety Disorder - 7 scale (GAD-7)

    Baseline

  • Primary Health Questionnaire - 9 (PHQ-9)

    Baseline

  • Enjoyment of Interaction Scale

    45 minutes

Study Arms (1)

Adults with acute mood disorders

Adults aged over 18 diagnosed with an acute episode of a mood disorder using DSM-V criteria

Other: African drumming

Interventions

Rhythmic beating or tapping of a variety of percussion instruments, which often occurs within a group setting

Also known as: Drumming
Adults with acute mood disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • Attending mental health clinic
  • Diagnosed mood disorder
  • Voluntarily attending drumming group

You may not qualify if:

  • Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive DisorderBipolar Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBipolar and Related Disorders

Study Officials

  • Nicola A Plastow, PhD

    University of Stellenbosch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Occupational Therapy

Study Record Dates

First Submitted

January 20, 2016

First Posted

February 5, 2016

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

February 5, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share