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Completed

NCT Number: NCT03503526

Trauma-focused Group Music and Imagery With Traumatized Women

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Receptive Music Therapy

Behavioral

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 names: Group Music and Imagery and Expressive Arts therapy

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).

    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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Council of the Danish Victims Fund
  • Kris- och Traumacentrum Sverige AB

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2018
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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