Stress Disorders, Post-TraumaticNCT03503526

Trauma-focused Group Music and Imagery With Traumatized Women

A study testing Receptive music therapy in people with Stress Disorders, Post-Traumatic, run by Aalborg University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Stress Disorders, Post-Traumatic
What is being tested?: Receptive music therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: No sites listed yet
Study dates: 13 Aug 2015to 22 Aug 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: Trauma-focused Group Music and Imagery With Women Suffering From PTSD/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).

Read the 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.

Conditions: Stress Disorders, Post-Traumatic
Being tested: Receptive music therapy
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Receptive music therapyBehavioural
Also called Group Music and Imagery and Expressive Arts 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.

Study groups in NCT03503526
Study group	Role	What they receive
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. Receives: Behavioral: Receptive music therapy
Wait List Control	No intervention	No treatment for approximately 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 201522 Aug 2018

First posted20 Apr 2018
Study start13 Aug 2015
Primary completion22 Aug 2018
Study completion22 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomized wait list control study with a mixed methods design
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03503526
Sponsor's protocol ID: 2015/895-31
Other IDs: 15-910-00019
Status last verified: Jan 2021
First submitted: 19 Feb 2018
Last updated: 19 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 9492235
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.
PubMed 23995026
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.
PubMed 3783140
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.
PubMed 26653052
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.
PubMed 4808738
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.
PubMed 3186891
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.
PubMed 27723542
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.
PubMed 19673812
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.
PubMed 17454728
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.
PubMed 9395146
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.
PubMed 3675137
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.
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.
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.
Bruscia K E, Grocke DE. Guided imagery and music: the Bonny method and beyond. Gilsum, NH: Barcelona Pub. 2002.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Stress Disorders, Post-Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trauma-focused Group Music and Imagery With Women Suffering From PTSD/Complex PTSD
ClinicalTrials.gov ID: NCT03503526
Acronym / sponsor ID: 2015/895-31
Conditions: Stress Disorders, Post-Traumatic
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Aalborg UniversityUniversity, hospital or other
Collaborators: Kris- och Traumacentrum Sverige AB, Council of the Danish Victims Fund
Study start: 13 Aug 2015 (actual)
Primary completion: 22 Aug 2018 (actual)
Study completion: 22 Aug 2018 (actual)
First posted: 20 Apr 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary outcome is pre, post and 3 months follow-up measures of PTSD checklist 5 (PCL-5).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A randomized wait list control study with a mixed methods design

Arm	Type	Receives
Music therapy treatment	Experimental	Behavioral: Receptive music therapyAn intervention consisting of 12 weekly sessions of trauma-focused treatment in form of group music and imagery therapy. Receptive music therapy.
Wait List Control	No intervention	–No treatment for approximately 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

difficulties in understanding or making themselves understood in swedish,
severe personality disorder or neuropsychiatric disorder,
ongoing alcohol or drug abuse,
psychotic disorder,
suicidality,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Receptive music therapyAlso: Group Music and Imagery and Expressive Arts therapy12 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.	Behavioural	Music therapy treatment

Primary outcome

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.

9 secondary outcomes

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).
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).
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).
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).
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).
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).
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).
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).
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
Background: PubMed 9492235Adler 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.
Background: PubMed 23995026First 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.
Background: PubMed 3783140Bernstein 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.
Background: PubMed 26653052Bovin 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.
Background: PubMed 4808738Derogatis 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.
Background: PubMed 3186891Horowitz 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.
Background: PubMed 27723542Karatzias 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.
Background: PubMed 19673812Koelsch 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.
Background: PubMed 17454728Korlin 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.
Background: PubMed 9395146Nijenhuis 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.
Background: PubMed 3675137Pitman 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.
BackgroundRudstam 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Receptive music therapy in people with Stress Disorders, Post-Traumatic, run by Aalborg University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03503526, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.