DepressionNCT03917979
The Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Depression
A study testing Individual GIM in people with Depression, run by Aalborg University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Individual GIM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Mar 2019to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Guided Imagery and Music Research
Saint Paul, Minnesota, 55110
Tim Honig, MMT, 302-285-9989, honigtj@appstate.edu
- Recruiting
Guided Imagery and Music Research
Westfield, Massachusetts, 01085
Timothy J Honig, MMT, 302-285-9989, honigtj@appstate.edu
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Individual GIM, Waitlist Control
- Keywords
- Music Therapy, Guided Imagery, Randomized Controlled Trial
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual GIMBehavioural
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.
Waitlist ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual GIM | Experimental | Participants are provided with a series of individual GIM sessions. Receives: Behavioral: Individual GIM |
| Waitlist Control | Other | Participants complete an initial wait list period, then are provided with a series of Group GIM sessions. Receives: Behavioral: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Pretest at the time of enrollment, midpoint (week 10), posttest (week 20), 6-week follow-up (week 26), 12-week follow-up (week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start20 Mar 2019
- Primary completion20 Jun 2020 (estimated)
- Study completion20 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Appalachian State University
- Responsible party
- Principal investigator, Tim Honig, Aalborg University
- Investigators
- Timothy J Honig, MMT, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917979
- Sponsor's protocol ID
- GIM Depression
- Status last verified
- Aug 2019
- First submitted
- 13 Apr 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21499543Chou 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.
PubMed 16741859Grocke D. Overview of research in the Bonny Method of Guided Imagery and Music. Voices: A World Forum for Music Therapy, 10(3), 2010
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.
PubMed 20492059Lovibond 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.
PubMed 7726811Maack 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.
PubMed 10519844McKinney 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.
PubMed 27941132Rush 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.
PubMed 15578008Tennant 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.
PubMed 18042300
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03917979
- Acronym / sponsor ID
- GIM Depression
- Conditions
- Depression
- Keywords
- Music Therapy, Guided Imagery, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Appalachian State University
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Jun 2020 (estimated)
- Study completion
- 20 Aug 2020 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual GIM | Experimental | Behavioral: Individual GIMParticipants are provided with a series of individual GIM sessions. |
| Waitlist Control | Other | Behavioral: Waitlist ControlParticipants complete an initial wait list period, then are provided with a series of Group GIM sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual GIMParticipants 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. | Behavioural | Individual GIM |
| Waitlist ControlParticipants 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. | Behavioural | Waitlist Control |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Background: PubMed 21499543Borrelli 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.
- Background: PubMed 16741859Chou 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.
- BackgroundGrocke D. Overview of research in the Bonny Method of Guided Imagery and Music. Voices: A World Forum for Music Therapy, 10(3), 2010
- Background: PubMed 20492059Lin 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.
- Background: PubMed 7726811Lovibond 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.
- Background: PubMed 10519844Maack 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.
- Background: PubMed 27941132McKinney 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.
- Background: PubMed 15578008Rush 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.
- Background: PubMed 18042300Tennant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy J Honig, MMT principal investigator
Aalborg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual GIM in people with Depression, run by Aalborg University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy J Honig, MMT (630-779-4298, timhonig@hum.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917979, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.