Back to resultsTrauma-focused Group Music and Imagery With Traumatized Women
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Receptive music therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music therapy treatment
Wait List Control
Arm Description
An intervention consisting of 12 weekly sessions of trauma-focused treatment in form of group music and imagery therapy. Receptive music therapy.
No treatment for approximately 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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).
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).
Full Information
NCT ID
NCT03503526
First Posted
February 19, 2018
Last Updated
January 15, 2021
Sponsor
Aalborg University
Collaborators
Kris- och Traumacentrum Sverige AB, Council of the Danish Victims Fund
1. Study Identification
Unique Protocol Identification Number
NCT03503526
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 13, 2015 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Kris- och Traumacentrum Sverige AB, Council of the Danish Victims Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized wait list control study with a mixed methods design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music therapy treatment
Arm Type
Experimental
Arm Description
An intervention consisting of 12 weekly sessions of trauma-focused treatment in form of group music and imagery therapy.
Receptive music therapy.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
No treatment for approximately 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Receptive music therapy
Other Intervention Name(s)
Group Music and Imagery and Expressive Arts therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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).
Secondary Outcome Measure Information:
Title
Change from baseline in Dissociative experience scale (DES) mean score at 3 months (post intervention) and at 6 months (follow- up).
Description
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).
Title
Change from baseline in Hopkins symptom checklist (HSCL-25) mean scores at 3 months (post intervention) and at 6 months (follow- up).
Description
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).
Title
Change from baseline in Positive states of mind scale (PSOM-S) total score at 3 months (post intervention) and at 6 months (follow- up).
Description
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).
Title
Change from baseline in Somatoform Dissociation Questionnaire (SDQ5) total score at 3 months (post intervention) and at 6 months (follow- up).
Description
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).
Title
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).
Description
Heart rate (bpm) measured with a blood volume pulse sensor.
Time Frame
Baseline, 3 months (post intervention) and 6 months (follow- up).
Title
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).
Description
Temperature measured on the fingertip of the left hand´s middle finger.
Time Frame
Baseline, 3 months (post intervention) and 6 months (follow- up).
Title
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).
Description
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).
Title
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).
Description
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).
Title
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).
Description
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).
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Male subjects meeting the inclusion criteria are not readily available at the clinic where the study is conducted.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Trauma-focused Group Music and Imagery With Traumatized Women
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