NCT03503526

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

February 19, 2018

Last Update Submit

January 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change from baseline in Dissociative experience scale (DES) mean score at 3 months (post intervention) and at 6 months (follow- up).

    Baseline, 3 months (post intervention) and 6 months (follow- up).

  • Change from baseline in Hopkins symptom checklist (HSCL-25) mean scores at 3 months (post intervention) and at 6 months (follow- up).

    Baseline, 3 months (post intervention) and 6 months (follow- up).

  • Change from baseline in Positive states of mind scale (PSOM-S) total score at 3 months (post intervention) and at 6 months (follow- up).

    Baseline, 3 months (post intervention) and 6 months (follow- up).

  • Change from baseline in Somatoform Dissociation Questionnaire (SDQ5) total score at 3 months (post intervention) and at 6 months (follow- up).

    Baseline, 3 months (post intervention) and 6 months (follow- up).

  • 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).

    Baseline, 3 months (post intervention) and 6 months (follow- up).

  • +4 more secondary outcomes

Study Arms (2)

Music therapy treatment

EXPERIMENTAL

An intervention consisting of 12 weekly sessions of trauma-focused treatment in form of group music and imagery therapy. Receptive music therapy.

Behavioral: Receptive music therapy

Wait List Control

NO INTERVENTION

No treatment for approximately 12 weeks.

Interventions

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.

Also known as: Group Music and Imagery and Expressive Arts therapy
Music therapy treatment

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMale subjects meeting the inclusion criteria are not readily available at the clinic where the study is conducted.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1097/00006842-199801000-00006.

    PMID: 9492235BACKGROUND
  • 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.

    PMID: 23995026BACKGROUND
  • 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.

    PMID: 3783140BACKGROUND
  • 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.

    PMID: 26653052BACKGROUND
  • 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.

    PMID: 4808738BACKGROUND
  • 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.

    PMID: 3186891BACKGROUND
  • 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.

    PMID: 27723542BACKGROUND
  • 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.

    PMID: 19673812BACKGROUND
  • 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.

    PMID: 17454728BACKGROUND
  • 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.

    PMID: 9395146BACKGROUND
  • 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.

    PMID: 3675137BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

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

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

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized wait list control study with a mixed methods design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2018

First Posted

April 20, 2018

Study Start

August 13, 2015

Primary Completion

August 22, 2018

Study Completion

August 22, 2018

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share