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

August 20, 2019 updated by: Tim Honig, Aalborg University

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Background: The Bonny Method of Guided Imagery and Music is a music-centered depth approach to exploring the self. In GIM, 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 transformative process.

Preliminary evidence suggests that the Bonny Method of Guided Imagery and Music may be an appropriate therapeutic approach for persons with depression. Used in psychotherapy, it has been documented as treatment for depression in qualitative research, case studies and clinical practice. There is quantitative evidence that GIM may be effective at reducing depression and related symptoms in a variety of clinical and nonclinical populations. A systematic review examined the evidence of psychological and physiological change associated with a series of individual GIM sessions and found a cluster of positive treatment effects related to mood including improvements in depression and depressed mood, mood disturbance, and anxiety. There is also evidence that these treatment effects may persist over time.

Design: This quantitative research will use a split-plot factorial, or mixed, design with two conditions: (a) an experimental group who receive a series of individual GIM sessions and (b) a waitlist control group who receive a series of group GIM sessions after completing a waitlist period. The research is utilizing a waitlist control condition to meet the ethical demand of providing a degree of parity between experimental and control condition, improve feasibility of the research, and to mitigate bias produced by the inability to fully mask participants to their group assignment. The research will be conducted in a naturalistic setting in a private office in a psychology and counseling practice that has been retained for the length of the research study. This research is studying intervention effectiveness rather than efficacy, and therefore the design allows for a degree of flexibility with the provision of the intervention as is normal in a real-world clinical setting.

Recruitment: Adults seeking treatment for depression will be recruited from outpatient mental health care providers and from the community. At the time of enrollment in the study, participants will be asked to provide the name and contact information of their most recent mental health care provider. In the event that a participant requires more intensive treatment while participating in the research study, the participant will be referred to that mental health care provider for a formal assessment. If a participant does not provide information for a mental health care provider, they will be referred to a mental health assessment and referral center in the community.

Randomization: After providing informed consent and verifying that they meet all eligibility requirements, participants are randomly assigned to either a treatment condition or waitlist control condition. The study will use block randomization to ensure even group allocation at both clinical sites, and will be conducted by a member of the research team who is not involved in recruitment, screening, or providing the intervention.

Clinical Sites: Clinical sessions for the study will take place at two research sites in the United States: one metropolitan area in the Midwest and one in the mid-Atlantic. The individual and group GIM sessions will be conducted by board-certified music therapists (MT-BC) who have completed training in the Bonny Method of Guided Imagery and Music as endorsed by the Association for Music and Imagery, and have the credential Fellow of the Association for Music and Imagery (FAMI).

Quality Assurance: To ensure consistent and high-quality treatment and maximize internal and external validity, the research team will monitor fidelity to the GIM approach in each session with a GIM Treatment Fidelity Assessment, created for the purposes of this research. This assessment will be completed by the therapist immediately following each GIM session. Any signs of variation, drift, or bias will be discussed with the research team. The therapists will also receive clinical supervision from an experienced GIM supervisor throughout the course of the study. All sessions will be audio-recorded for reference related to quality assurance.

Data Collection: All participants complete data collection packets at pre-test, midpoint (week 10), posttest (week 20), 6-week follow-up, and 12-week follow-up. Based on power calculations using effect size estimates (d = 0.5) from previous research, the study is seeking a total of 30 participants, adjusted to include an additional 20% to account for attrition. At each time point, participants will complete self-report measures related to depression, anxiety, and mental well-being, and give information about changes in other therapies or medical treatment. Because this is the first randomized controlled trial (RCT) examining GIM in the treatment of depression, the study is not controlling access to other therapies or medical care while participants are involved in the study. However, information on other therapies or medical care will be collected at all data points to allow the researchers to assess the degree to which these factors may have biased the results in the final analysis.

Data Analysis: In the case of attrition or missing data, statistical analysis will utilize the intent-to-treat principle. Data analysis will be conducted using Statistical Package for the Social Sciences (SPSS) and analyzed according to the split-plot factorial design. The factors are 1) treatment group and 2) time. Factor 1 has two levels: GIM and waitlist control. Factor 2 has four levels: pretest, midpoint, posttest, and 6-week follow-up. Note that the 12-week follow-up will not be included in the main data analysis because the waitlist control group will have received Group GIM during that period. A secondary repeated measures analysis of the experimental group will be undertaken to examine the 12-week follow-up data.

The data will first be examined to test the assumptions for parametric statistics with split-plot factorial ANOVA. If the data do not meet these assumptions, the data will be analyzed using aligned rank-transformation. Once aligned and rank-transformed, the data will be analyzed using split-plot factorial ANOVA.

If the data do meet the assumptions for parametric statistics, the data will be analyzed using split-plot factorial ANOVA. In the case of a nonsignificant or ordinal interaction, main effects will be examined. In the case of a significant disordinal interaction, a simple effects analysis will be completed for time within-subjects. In the case of significant change in any of the dependent variables over time, post hoc analyses will be conducted to determine between which time points the significant change occurred. Effect sizes (Cohen's d) and confidence intervals will be calculated and reported for all outcomes, as appropriate.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Westfield, Massachusetts, United States, 01085
        • Recruiting
        • Guided Imagery and Music Research
        • Contact:
    • Minnesota
      • Saint Paul, Minnesota, United States, 55110
        • Recruiting
        • Guided Imagery and Music Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual GIM
Participants are provided with a series of individual GIM sessions.
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.
Other: Waitlist Control
Participants complete an initial wait list period, then are provided with a series of Group GIM sessions.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Timothy J Honig, MMT, Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Anticipated)

June 20, 2020

Study Completion (Anticipated)

August 20, 2020

Study Registration Dates

First Submitted

April 13, 2019

First Submitted That Met QC Criteria

April 13, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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