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Trial record 69 of 1325 for:    Recruiting, Not yet recruiting, Available Studies | "Depression"

The Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT03917979
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Appalachian State University
Information provided by (Responsible Party):
Tim Honig, Aalborg University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Individual GIM Behavioral: Waitlist Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: It is not possible to fully mask participants to the treatment they receive since they will know whether their sessions start immediately or after 20 weeks and whether their sessions are individual or in a group. Similarly, it is not possible to mask the care provider to the participants' condition. However, participants will be masked to which condition is the experimental condition and which is the control condition, and all will receive a series of GIM sessions either in groups or as individuals. The outcome assessors will be masked to participants' group assignment during data collection since participants will complete data collection procedures by mailed packet of self-report measures. All self-report packets will be identified only by a unique client number.
Primary Purpose: Treatment
Official Title: Effectiveness of the Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Depression: A Randomized Controlled Trial
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : August 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Individual GIM
Participants are provided with a series of individual GIM sessions.
Behavioral: Individual GIM
Participants are provided with a series of 10 individual GIM sessions, scheduled once every two weeks. Frequency may change if clinically indicated. Individual GIM sessions begin with a discussion of important issues related to the client's life and symptoms, forming a focus for the session. Then, the therapist provides suggestions to help the client become highly relaxed and focused in preparation for the music-listening portion of the session. The therapist plays specially-selected music from the Western classical tradition to match the client and the focus for the session, and engages in verbal dialogue with the client to help them explore their own internal imagery while listening to the music. After the music ends, the therapist and client engage in discussion about their imagery in metaphoric connection to their therapeutic process. This may include arts-based approaches to process the session. Sessions last approximately 90-120 minutes.

Waitlist Control
Participants complete an initial wait list period, then are provided with a series of Group GIM sessions.
Behavioral: Waitlist Control
Participants complete an initial wait list period of 26 weeks, equivalent to the treatment and 6-week follow-up period for the experimental arm. They are then provided with four Group GIM sessions scheduled once per week. Group GIM sessions start with a group discussion about events or feelings from the week and issues related to depression and wellbeing. Then the therapist provides suggests to help the clients relax and focus in preparation for the music-listening period. Group members will explore a theme or issue related to therapy while focusing on whatever comes to them as the music is played. After the music, there will be a time to work with the imagery experienced during the music. This may be in the form of discussion or other art forms. The session ends with a discussion about gains and insights from the music and imagery. Sessions last 90-120 minutes.




Primary Outcome Measures :
  1. Mean change from baseline in Depression score as measured by the IDS-SR [ Time Frame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) ]
    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.

  2. Mean change from baseline in Depression score as measured by the Depression, Anxiety, and Stress Scales (DASS) [ Time Frame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) ]
    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.

  3. Mean change from baseline in Anxiety score as measured by the Depression, Anxiety, and Stress Scales (DASS) [ Time Frame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) ]
    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.

  4. Mean change from baseline in mental well-being score as measured by the WEMWBS [ Time Frame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) ]
    Score for the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). Change is assessed among all timepoints.


Secondary Outcome Measures :
  1. Mean change from baseline in Stress score, as measured by the Depression, Anxiety, and Stress Scales (DASS) [ Time Frame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917979


Contacts
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Contact: Timothy J Honig, MMT 630-779-4298 timhonig@hum.aau.dk
Contact: Niels Hannibal, PhD +45 9940 9109 hannibal@hum.aau.dk

Locations
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United States, Massachusetts
Guided Imagery and Music Research Recruiting
Westfield, Massachusetts, United States, 01085
Contact: Timothy J Honig, MMT    302-285-9989    honigtj@appstate.edu   
United States, Minnesota
Guided Imagery and Music Research Recruiting
Saint Paul, Minnesota, United States, 55110
Contact: Tim Honig, MMT    302-285-9989    honigtj@appstate.edu   
Sponsors and Collaborators
Aalborg University
Appalachian State University
Investigators
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Principal Investigator: Timothy J Honig, MMT Aalborg University

Publications:
Grocke D. Overview of research in the Bonny Method of Guided Imagery and Music. Voices: A World Forum for Music Therapy, 10(3), 2010

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Responsible Party: Tim Honig, PhD Researcher, Doctoral Programme in Music Therapy, Aalborg University
ClinicalTrials.gov Identifier: NCT03917979     History of Changes
Other Study ID Numbers: GIM Depression
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tim Honig, Aalborg University:
Music Therapy
Guided Imagery
Randomized Controlled Trial
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders