Clinical trial NCT03503526: Trauma-focused Group Music and Imagery With Traumatized Women
Official title: Trauma-focused Group Music and Imagery With Women Suffering From PTSD/Complex PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Kris- och Traumacentrum Sverige AB
name: Council of the Danish Victims Fund
First posted: 2018-04-20
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized wait list control study with a mixed methods design
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
Secondary outcomes:
measure: Change from baseline in Dissociative experience scale (DES) mean score at 3 months (post intervention) and at 6 months (follow- up).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
measure: Change from baseline in Hopkins symptom checklist (HSCL-25) mean scores at 3 months (post intervention) and at 6 months (follow- up).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
measure: Change from baseline in Positive states of mind scale (PSOM-S) total score at 3 months (post intervention) and at 6 months (follow- up).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
measure: Change from baseline in Somatoform Dissociation Questionnaire (SDQ5) total score at 3 months (post intervention) and at 6 months (follow- up).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
measure: 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).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
measure: 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).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
measure: 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).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
measure: 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).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
measure: 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).
timeFrame: Baseline, 3 months (post intervention) and 6 months (follow- up).
Other outcomes:
Locations:
Study officials:
References:
citation: 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. doi: 10.1097/00006842-199801000-00006.
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. No abstract available.
citation: Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. doi: 10.1097/00005053-198612000-00004.
citation: 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.
citation: 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. doi: 10.1002/bs.3830190102. No abstract available.
citation: 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. doi: 10.1097/00006842-198809000-00004.
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.
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.
citation: Korlin D, Edman G, Nyback H. Reliability and validity of a Swedish version of the Dissociative Experiences Scale (DES-II). Nord J Psychiatry. 2007;61(2):126-42. doi: 10.1080/08039480701226112.
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. doi: 10.1111/j.1600-0447.1997.tb09922.x.
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. doi: 10.1001/archpsyc.1987.01800230050009.
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.
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.
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.
citation: Bruscia K E, Grocke DE. Guided imagery and music: the Bonny method and beyond. Gilsum, NH: Barcelona Pub. 2002.
citation: Grocke DE, Moe T (Eds.). Guided imagery & music (GIM) and music imagery methods for individual and group therapy. Philadelphia: Jessica Kingsley Publishers. 2015.
citation: 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