NCT03917979

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

April 13, 2019

Last Update Submit

August 20, 2019

Conditions

Keywords

Music TherapyGuided ImageryRandomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (1)

  • Mean change from baseline in Stress score, as measured by the Depression, Anxiety, and Stress Scales (DASS)

    Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32)

Study Arms (2)

Individual GIM

EXPERIMENTAL

Participants are provided with a series of individual GIM sessions.

Behavioral: Individual GIM

Waitlist Control

OTHER

Participants complete an initial wait list period, then are provided with a series of Group GIM sessions.

Behavioral: Waitlist Control

Interventions

Individual GIMBEHAVIORAL

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.

Individual GIM

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.

Waitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guided Imagery and Music Research

Westfield, Massachusetts, 01085, United States

RECRUITING

Guided Imagery and Music Research

Saint Paul, Minnesota, 55110, United States

RECRUITING

Related Publications (9)

  • Borrelli B. The Assessment, Monitoring, and Enhancement of Treatment Fidelity In Public Health Clinical Trials. J Public Health Dent. 2011 Winter;71(s1):S52-S63. doi: 10.1111/j.1752-7325.2011.00233.x.

    PMID: 21499543BACKGROUND
  • Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. doi: 10.1097/01.jnr.0000387567.41941.14.

    PMID: 16741859BACKGROUND
  • Grocke D. Overview of research in the Bonny Method of Guided Imagery and Music. Voices: A World Forum for Music Therapy, 10(3), 2010

    BACKGROUND
  • Lin MF, Hsu MC, Chang HJ, Hsu YY, Chou MH, Crawford P. Pivotal moments and changes in the Bonny Method of Guided Imagery and Music for patients with depression. J Clin Nurs. 2010 Apr;19(7-8):1139-48. doi: 10.1111/j.1365-2702.2009.03140.x.

    PMID: 20492059BACKGROUND
  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PMID: 7726811BACKGROUND
  • Maack C, Nolan P. The Effects of Guided Imagery andMusic Therapy on Reported Change in Normal Adults. J Music Ther. 1999;36(1):39-55. doi: 10.1093/jmt/36.1.39.

    PMID: 10519844BACKGROUND
  • McKinney CH, Honig TJ. Health Outcomes of a Series of Bonny Method of Guided Imagery and Music Sessions: A Systematic Review. J Music Ther. 2017 Mar 1;54(1):1-34. doi: 10.1093/jmt/thw016.

    PMID: 27941132BACKGROUND
  • 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. doi: 10.1038/sj.npp.1300614.

    PMID: 15578008BACKGROUND
  • Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

    PMID: 18042300BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Timothy J Honig, MMT

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy J Honig, MMT

CONTACT

Niels Hannibal, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Researcher, Doctoral Programme in Music Therapy

Study Record Dates

First Submitted

April 13, 2019

First Posted

April 17, 2019

Study Start

March 20, 2019

Primary Completion

June 20, 2020

Study Completion

August 20, 2020

Last Updated

August 22, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations