Clinical trial NCT03917979: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Music Therapy
Guided Imagery
Randomized Controlled Trial
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Appalachian State University
First posted: 2019-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change from baseline in Depression score as measured by the IDS-SR
timeFrame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32)
measure: Mean change from baseline in Depression score as measured by the Depression, Anxiety, and Stress Scales (DASS)
timeFrame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32)
measure: Mean change from baseline in Anxiety score as measured by the Depression, Anxiety, and Stress Scales (DASS)
timeFrame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32)
measure: Mean change from baseline in mental well-being score as measured by the WEMWBS
timeFrame: 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:
measure: Mean change from baseline in Stress score, as measured by the Depression, Anxiety, and Stress Scales (DASS)
timeFrame: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32)
Other outcomes:
Locations:
city: Westfield
country: United States
facility: Guided Imagery and Music Research
state: Massachusetts
city: Saint Paul
country: United States
facility: Guided Imagery and Music Research
state: Minnesota
Study officials:
affiliation: Aalborg University
name: Timothy J Honig, MMT
role: PRINCIPAL_INVESTIGATOR
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