Trauma-focused Group Music and Imagery With Traumatized Women

• ClinicalTrials.gov Identifier: NCT03503526
• Recruitment Status: Completed
• First Posted: April 20, 2018
• Last Update Posted: January 19, 2021
• Sponsor: Aalborg University
• Collaborators: Kris- och Traumacentrum Sverige AB; Council of the Danish Victims Fund
• Information provided by (Responsible Party): Gabriella Rudstam, Aalborg University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Stress Disorders, Post-Traumatic	Behavioral: Receptive music therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized wait list control study with a mixed methods design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trauma-focused Group Music and Imagery With Women Suffering From PTSD/Complex PTSD
• Actual Study Start Date: August 13, 2015
• Actual Primary Completion Date: August 22, 2018
• Actual Study Completion Date: August 22, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Music therapy treatment; 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; 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.; Other Name: Group Music and Imagery and Expressive Arts therapy
No Intervention: Wait List Control; No treatment for approximately 12 weeks.

Outcome Measures

Primary Outcome Measures :

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). [ Time Frame: Baseline, 3 months (post intervention) and 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.

Secondary Outcome Measures :

1. Change from baseline in Dissociative experience scale (DES) mean score at 3 months (post intervention) and at 6 months (follow- up). [ Time Frame: Baseline, 3 months (post intervention) and 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.
2. Change from baseline in Hopkins symptom checklist (HSCL-25) mean scores at 3 months (post intervention) and at 6 months (follow- up). [ Time Frame: Baseline, 3 months (post intervention) and 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.
3. Change from baseline in Positive states of mind scale (PSOM-S) total score at 3 months (post intervention) and at 6 months (follow- up). [ Time Frame: Baseline, 3 months (post intervention) and 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.
4. Change from baseline in Somatoform Dissociation Questionnaire (SDQ5) total score at 3 months (post intervention) and at 6 months (follow- up). [ Time Frame: Baseline, 3 months (post intervention) and 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.
5. 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). [ Time Frame: Baseline, 3 months (post intervention) and 6 months (follow- up). ]
   Heart rate (bpm) measured with a blood volume pulse sensor.
6. 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). [ Time Frame: Baseline, 3 months (post intervention) and 6 months (follow- up). ]
   Temperature measured on the fingertip of the left hand´s middle finger.
7. 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). [ Time Frame: Baseline, 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.
8. 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). [ Time Frame: Baseline, 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).
9. 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). [ Time Frame: Baseline, 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male subjects meeting the inclusion criteria are not readily available at the clinic where the study is conducted.
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

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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

• Responsible Party: Gabriella Rudstam, Principal Investigator, Aalborg University
• ClinicalTrials.gov Identifier: NCT03503526
• Other Study ID Numbers: 2015/895-31; 15-910-00019 ( Other Grant/Funding Number: Council of the Danish Victims Fund )
• First Posted: April 20, 2018
• Last Update Posted: January 19, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders