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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individual GIM
Waitlist Control
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Music Therapy, Guided Imagery, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guided Imagery and Music ResearchRecruiting
  • Guided Imagery and Music ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Individual GIM

Waitlist Control

Arm Description

Participants are provided with a series of individual GIM sessions.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 13, 2019
Last Updated
August 20, 2019
Sponsor
Aalborg University
Collaborators
Appalachian State University
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1. Study Identification

Unique Protocol Identification Number
NCT03917979
Brief Title
The Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Depression
Official Title
Effectiveness of the Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Depression: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
June 20, 2020 (Anticipated)
Study Completion Date
August 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Appalachian State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Music Therapy, Guided Imagery, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual GIM
Arm Type
Experimental
Arm Description
Participants are provided with a series of individual GIM sessions.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
Participants complete an initial wait list period, then are provided with a series of Group GIM sessions.
Intervention Type
Behavioral
Intervention Name(s)
Individual GIM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Control
Intervention Description
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 Measure Information:
Title
Mean change from baseline in Depression score as measured by the IDS-SR
Description
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.
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)
Title
Mean change from baseline in Depression score as measured by the Depression, Anxiety, and Stress Scales (DASS)
Description
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.
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)
Title
Mean change from baseline in Anxiety score as measured by the Depression, Anxiety, and Stress Scales (DASS)
Description
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.
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)
Title
Mean change from baseline in mental well-being score as measured by the WEMWBS
Description
Score for the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). Change is assessed among all timepoints.
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)
Secondary Outcome Measure Information:
Title
Mean change from baseline in Stress score, as measured by the Depression, Anxiety, and Stress Scales (DASS)
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy J Honig, MMT
Phone
630-779-4298
Email
timhonig@hum.aau.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Niels Hannibal, PhD
Phone
+45 9940 9109
Email
hannibal@hum.aau.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Honig, MMT
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guided Imagery and Music Research
City
Westfield
State/Province
Massachusetts
ZIP/Postal Code
01085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy J Honig, MMT
Phone
302-285-9989
Email
honigtj@appstate.edu
Facility Name
Guided Imagery and Music Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Honig, MMT
Phone
302-285-9989
Email
honigtj@appstate.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Results Reference
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PubMed Identifier
16741859
Citation
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Results Reference
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Citation
Grocke D. Overview of research in the Bonny Method of Guided Imagery and Music. Voices: A World Forum for Music Therapy, 10(3), 2010
Results Reference
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PubMed Identifier
20492059
Citation
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.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
10519844
Citation
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.
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Citation
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Citation
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The Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Depression

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