Depression Clinical Trial
Official title:
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.
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.
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