Depression Clinical Trial
Official title:
Effectiveness of the Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Depression: A Randomized Controlled Trial
The purpose of this research is to study the effectiveness of the Bonny Method of Guided
Imagery and Music (GIM) as a treatment approach for depression. Specifically, this study will
examine the treatment outcomes of a series of individual GIM sessions for persons with mild
or moderate depression. It is guided by the following three research questions: In
individuals with depression, does a series of GIM sessions 1) reduce severity of depression,
2) reduce severity of anxiety, and 3) improve mental well-being in comparison to a control
group? The hypothesis is that a series of individual GIM sessions will be associated with
improvement in depression, anxiety, and mental well-being that is greater than the waitlist
control group.
GIM is a music-centered integrative therapy approach. In it, therapist-selected programs of
music from the Western classical tradition are used to evoke and develop a client's
spontaneously generated imagery in a highly focused non-ordinary state of consciousness. In
dialogue with the therapist, the client explores this imagery in a metaphoric, transformative
process.
After providing informed consent and verifying that they meet all eligibility requirements,
30 participants are randomly assigned to either a treatment condition or waitlist control
condition. Participants in the treatment group are provided with a series of 10 individual
GIM sessions occurring once every two weeks. Individuals in the waitlist condition are
provided with a series of four Group GIM sessions after the initial waitlist period. All
participants complete data collection packets at pre-test, midpoint, posttest, 6-week
follow-up, and 12-week follow-up.
The individual and group GIM sessions are conducted by board-certified music therapists
(MT-BC) who have completed training in the Bonny Method of Guided Imagery and Music and have
the credential Fellow of the Association for Music and Imagery (FAMI). The researchers will
implement a Quality Assurance protocol to monitor fidelity to treatment.
GIM is a therapeutic approach accessible on a limited basis worldwide, and trained
practitioners are granted credentials by the Association for Music and Imagery (AMI) and
Music and Imagery Association of Australia (MIAA). Databases of practitioners are available
through these organizations.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 20, 2020 |
Est. primary completion date | June 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults age 18 or over - Meet severity threshold for mild to moderate depression as measured by the Inventory of Depressive Symptomatology (IDS-SR; score of 14-38) at the time of enrollment - English-speaking - Able to read and write at a fifth grade level or higher Exclusion Criteria: - History of psychosis - Diagnosis related to depression other than unipolar depression, including but not limited to bipolar disorder and schizoaffective disorder - Meeting threshold for severe depression as measured by the Inventory of Depressive Symptomatology (IDS-SR; score greater than 38) at the time of enrollment |
Country | Name | City | State |
---|---|---|---|
United States | Guided Imagery and Music Research | Saint Paul | Minnesota |
United States | Guided Imagery and Music Research | Westfield | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Aalborg University | Appalachian State University |
United States,
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Rush AJ, Trivedi MH, Carmody TJ, Ibrahim HM, Markowitz JC, Keitner GI, Kornstein SG, Arnow B, Klein DN, Manber R, Dunner DL, Gelenberg AJ, Kocsis JH, Nemeroff CB, Fawcett J, Thase ME, Russell JM, Jody DN, Borian FE, Keller MB. Self-reported depressive symptom measures: sensitivity to detecting change in a randomized, controlled trial of chronically depressed, nonpsychotic outpatients. Neuropsychopharmacology. 2005 Feb;30(2):405-16. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change from baseline in Depression score as measured by the IDS-SR | Mean change in total score (range of 0-84) for the Inventory of Depressive Symptomatology - Self-report (IDS-SR). Change is assessed among all time points. A higher score represents greater severity of depressive symptoms, and a lower score represents a better outcome. | Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) | |
Primary | Mean change from baseline in Depression score as measured by the Depression, Anxiety, and Stress Scales (DASS) | Mean change in total score for the depression scale of the DASS. Scores for the depression scale range from 0-42. A higher score represents greater severity of depression and a worse outcome, and a lower score represents reduced depressive symptoms and a better outcome. Change is assessed among all timepoints. | Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) | |
Primary | Mean change from baseline in Anxiety score as measured by the Depression, Anxiety, and Stress Scales (DASS) | Mean change in total score for the Anxiety scale of the DASS. Scores for the Anxiety scale range from 0-42. A higher score represents greater severity of anxiety and a worse outcome, and a lower score represents a better outcome. Change is assessed among all timepoints. | Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) | |
Primary | Mean change from baseline in mental well-being score as measured by the WEMWBS | Score for the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). Change is assessed among all timepoints. | Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) | |
Secondary | Mean change from baseline in Stress score, as measured by the Depression, Anxiety, and Stress Scales (DASS) | Mean change in total score for the Stress scale of the DASS. Scores for the Stress scale range from 0-42. A higher score represents greater severity of stress and a worse outcome, and a lower score represents a better outcome. Change is assessed among all timepoints. | Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) |
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