Trauma-focused Group Music and Imagery With Traumatized Women

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Trauma-focused Group Music and Imagery With Women Suffering From PTSD/Complex PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503526
• Other study ID #: 2015/895-31
• Secondary ID: 15-910-00019
• Status: Completed
• Phase: N/A
• Start date: August 13, 2015
• Est. completion date: August 22, 2018

Study information

• Verified date: January 2021
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a mixed methods randomized controlled trial (Wait List Control), that investigates the effects of Group Music and Imagery (GrpMI) therapy in the treatment of women suffering from Post Traumatic Stress Disorder (PTSD) or Complex PTSD. The aim is to detect if the intervention has an effect on PTSD symptoms, dissociation, quality of life, and the capability of regulating the autonomic nervous system (ANS).

Description:

Participants are adult women suffering from PTSD or Complex PTSD (n=56) that are randomized to three months of weekly (12) sessions of trauma modified GrpMI therapy or no treatment for an equal amount of time (wait list control). Primary outcome is pre, post and 3 months follow-up measures of PTSD checklist 5 (PCL-5). Secondary outcome is pre, post and 3 months follow-up measures of dissociative experience scale (DES), positive state of mind scale (PSOM-S), Hopkins symptoms checklist (HSCL-25), somatoform dissociation questionnaire (SDQ-5), and reactivity and recovery of different physiological measures related to arousal regulation ability in a script driven imagery setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be suffering from PTSD/CPTSD,
• be sufficiently stabilised to tolerate being exposed to trauma treatment and listen to other subjects' stories,
• be able to speak good enough swedish to express themselves without an interpreter,
• have an interest in working with their problems using artistic languages,
• have an ability to work with symbolism and inner images.

Exclusion Criteria:

• difficulties in understanding or making themselves understood in swedish,
• severe personality disorder or neuropsychiatric disorder,
• ongoing alcohol or drug abuse,
• psychotic disorder,
• suicidality,
• serious ongoing medical condition,
• serious psychosocial problems.

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Receptive music therapy
12 weekly trauma-focused Group therapy sessions of a length of 2.5 hours. The core element is receptive music psychotherapy with music listening, art making, and other art based methods.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Aalborg University	Council of the Danish Victims Fund, Kris- och Traumacentrum Sverige AB

References & Publications (17)

Adler NE, Horowitz M, Garcia A, Moyer A. Additional validation of a scale to assess positive states of mind. Psychosom Med. 1998 Jan-Feb;60(1):26-32. — View Citation

Beck BD, Messell S, Cordtz TO, Sogaard U, Simonsen E, Moe T Feasibility of trauma-focused Guided Imagery and Music with adult refugees diagnosed with PTSD-a pilot study. Nordic Journal of Music Therapy 27(1): 67-86, 2018.

Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. — View Citation

Blake R, Bishop S. The Bonny Method of Guided Imagery and Music (GIM) in the Treatment of Post-Traumatic Stress Disorder (PTSD) with Adults in the Psychiatric Setting. Music Therapy Perspectives 12(2): 125-129, 1994.

Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14. — View Citation

Bruscia K E, Grocke DE. Guided imagery and music: the Bonny method and beyond. Gilsum, NH: Barcelona Pub. 2002.

Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974 Jan;19(1):1-15. — View Citation

First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. — View Citation

Grocke DE, Moe T (Eds.). Guided imagery & music (GIM) and music imagery methods for individual and group therapy. Philadelphia: Jessica Kingsley Publishers. 2015.

Hopper JW, Frewen PA, Sack M, Lanius RA, van der Kolk BA.The Responses to Script-Driven Imagery Scale (RSDI): Assessment of State Posttraumatic Symptoms for Psychobiological and Treatment Research. Journal of Psychopathology and Behavioral Assessment 29(4): 249-268, 2007. https://doi.org/10.1007/s10862-007-9046-0

Horowitz M, Adler N, Kegeles S. A scale for measuring the occurrence of positive states of mind: a preliminary report. Psychosom Med. 1988 Sep-Oct;50(5):477-83. — View Citation

Karatzias T, Shevlin M, Fyvie C, Hyland P, Efthymiadou E, Wilson D, Roberts N, Bisson JI, Brewin CR, Cloitre M. Evidence of distinct profiles of Posttraumatic Stress Disorder (PTSD) and Complex Posttraumatic Stress Disorder (CPTSD) based on the new ICD-11 Trauma Questionnaire (ICD-TQ). J Affect Disord. 2017 Jan 1;207:181-187. doi: 10.1016/j.jad.2016.09.032. Epub 2016 Sep 28. — View Citation

Koelsch S. A neuroscientific perspective on music therapy. Ann N Y Acad Sci. 2009 Jul;1169:374-84. doi: 10.1111/j.1749-6632.2009.04592.x. Review. — View Citation

Körlin D, Edman G, Nybäck H. Reliability and validity of a Swedish version of the Dissociative Experiences Scale (DES-II). Nord J Psychiatry. 2007;61(2):126-42. — View Citation

Nijenhuis ER, Spinhoven P, van Dyck R, van der Hart O, Vanderlinden J. The development of the somatoform dissociation questionnaire (SDQ-5) as a screening instrument for dissociative disorders. Acta Psychiatr Scand. 1997 Nov;96(5):311-8. — View Citation

Pitman RK, Orr SP, Forgue DF, de Jong JB, Claiborn JM. Psychophysiologic assessment of posttraumatic stress disorder imagery in Vietnam combat veterans. Arch Gen Psychiatry. 1987 Nov;44(11):970-5. — View Citation

Rudstam G, Elofsson U, Søndergaard HP, Bonde LO, Daniels Beck B. Trauma-focused music and imagery with women suffering from PTSD/complex PTSD: A feasibility study. Approaches: An Interdisciplinary Journal of Music Therapy, Special Issue 9(2): 147-158, 2017.

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Posttraumatic Stress Disorder Checklist (version 5) (PCL-5) total score at 3 months (post intervention) and at 6 months (follow- up).	PCL-5 is a 20-item self-assessment scale, measuring symptoms related to posttraumatic stress disorder (PTSD). The total score range are from 0-80. Higher scores indicate more severe PTSD symptoms.	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in Dissociative experience scale (DES) mean score at 3 months (post intervention) and at 6 months (follow- up).	DES is a 28-item self-assessment scale that measures psychoform dissociation. Each item ranges from 0 % to 100 % and the mean score is used as an index for the severity of the dissociative symptoms. A higher mean score indicates more dissociative symptoms.	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in Hopkins symptom checklist (HSCL-25) mean scores at 3 months (post intervention) and at 6 months (follow- up).	HSCL-25 is a 25-item self-assessment scale with two subscales. The first subscale measures anxiety and has 10 items. Each item ranges from 1 to 4. The mean score is used as an index of anxiety. A high mean score indicates more anxiety symptoms. The second subscale measures depression and has 15 items. Each item range from 1 to 4. The mean score is used as an index of depression. Higher mean score indicate more depressive symptoms.	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in Positive states of mind scale (PSOM-S) total score at 3 months (post intervention) and at 6 months (follow- up).	PSOM-S is a 5-item self-assessment scale that measures quality of life. The total range are from 5-15. Higher scores indicate a higher quality of life.	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in Somatoform Dissociation Questionnaire (SDQ5) total score at 3 months (post intervention) and at 6 months (follow- up).	SDQ5 is a 5-item self-assessment scale that measures somatoform dissociation. The total range are from 5-15. Higher scores indicates more severe somatoform dissociative symptoms.	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in timeline of heart rate during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).	Heart rate (bpm) measured with a blood volume pulse sensor.	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in timeline of peripheral temperature during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).	Temperature measured on the fingertip of the left hand´s middle finger.	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in timeline of skin conductance level during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).	Measured with electrodes on the proximal phalanges of the left hand´s index and ring finger.	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in timeline of muscle tension during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).	Measured as root mean square amplitude of the electromyography signal (micro volt) with electrodes placed on the left forearm (over the extensor digitorum muscle).	Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary	Change from baseline in timeline of the root mean square of successive differences (RMSSD) in intervals between individual heart beats during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).	Derived from the heart rate time series using the beat-to-beat peak blood volume-intervals (measured with a plethysmograph on the right middle finger).	Baseline, 3 months (post intervention) and 6 months (follow- up).