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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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.
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.
Time frame: Baseline, 3 months (post intervention) and 6 months (follow- up).
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.
Time frame: 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).
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.
Time frame: 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).
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.
Time frame: Baseline, 3 months (post intervention) and 6 months (follow- up).
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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.
Time frame: 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).
Heart rate (bpm) measured with a blood volume pulse sensor.
Time frame: Baseline, 3 months (post intervention) and 6 months (follow- up).
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.
Time frame: Baseline, 3 months (post intervention) and 6 months (follow- up).
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.
Time frame: Baseline, 3 months (post intervention) and 6 months (follow- up).
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).
Time frame: Baseline, 3 months (post intervention) and 6 months (follow- up).
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).
Time frame: Baseline, 3 months (post intervention) and 6 months (follow- up).