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Stress Disorders, Post-TraumaticRCT-KTFNCT02874235

Music Therapy and Treatment as Usual

A study testing Receptive music therapy and Psychological treatment in people with Stress Disorders, Post-Traumatic, run by Psychiatric Research Unit, Region Zealand, Denmark.

Completed

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

Official record
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Trial summary

This study compares music therapy with verbal psychotherapy (treatment as usual) in an outpatient psychiatric clinic for traumatized refugees. Based on positive results from a pilot study, the randomized clinical trial has a non-inferiority design to detect whether music therapy is not less effective than verbal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
Receptive music therapy and Psychological treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
No sites listed yet
Study dates
9 May 2016to 30 Nov 2019
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnostic Statistical Manual of Mental Disorders (DSM-5): Posttraumatic Stress Disorder Reaction: 309.81
  • Refugee status: Inhabitant in Denmark
  • International Classification of Diseases (ICD-10): F43.1: PTSD or
  • International Classification of Diseases (ICD-10): F62.0 Enduring personality change after catastrophic experience
  • Referred from a general practitioner or other unit of psychiatry

Who cannot join

  • International Classification of Diseases (ICD-10): F20-29 Schizophrenia or schizophrenia like diagnoses
  • Active Substance Abuse
  • Major Depression in connection with psychoses or suicidal risk

About this study

Official title: Music Therapy Versus Treatment as Usual: A Randomized Non-inferiority Study With Traumatized Refugees Diagnosed With PTSD

This study compares music therapy with verbal psychotherapy (treatment as usual) in an outpatient psychiatric clinic for traumatized refugees. Based on positive results from a pilot study, the randomized clinical trial has a non-inferiority design to detect whether music therapy is not less effective than verbal therapy carried out by psychologists and can serve as a complementary treatment modality (n=70).

The participants are adult Arabic, English or Danish speaking refugees suffering from posttraumatic stress disorder (PTSD). The patients are referred to outpatient treatment by their medical doctor. Data collection takes place in three locations of the clinic in Region Zealand, Denmark. The music therapy method used is Guided Imagery and Music (GIM).

Primary outcome is pre, post and 6 months follow-up measures of HTQ (Harvard Trauma Questionaire) and two measures of PTSD-8 during treatment. Secondary outcomes are pre, post and 6 months follow-up measures of Quality of Life Questionnaire (WHO-5), Dissociation Symptom Scale (DSS), Somatoform Dissociation Questionaire (SDQ-20), Revised Adult Attachment Scale (RAAS) and physiological measures (salivary oxytocin, betaendorphin and Substance P).

Read the detailed description

Subjects are randomized to 16 sessions of trauma modified GIM or 16 sessions of verbal psychotherapy (standard treatment).

N (70) is based on a power calculation using HTQ measures from similar refugee studies, with an estimated effect size in the range 0.6-0.8.

Sampling All baseline measures are scored during interview with a therapist before randomization. The primary post and follow-up measures (HTQ-R) are scored during interviews conducted by external psychologists blinded to the treatment group. The secondary post and follow-up measures are self-report questionnaires scored by the patients with the help of an educated translator who is blinded with regards to the treatment group.

0.5 ml salivary samples are collected in plastic tubes and stored at -20 degrees C.

The concentration of tree hormones (oxytocin, betaendorphin, substance P) are analyzed in a multiplex solution.

Intervention

The intervention is a phased trauma-oriented modification (tmGIM) of the Bonny Method of Guided Imagery and Music (GIM), where music listening and spontaneous imagery in an altered state of consciousness is used within a psychotherapeutic session to promote inner transformation and growth. The method was adapted by certain constraints:

Using only a limited selection of music with musical parameters, that fully support the trauma-oriented therapeutic goals and do not provoke flashbacks.

Using short music listening periods (2-10 minutes). Listening in an upright position. Inclusion of music from Middle-Eastern cultures. Inclusion of psychoeducation and introductory mindfulness based exercises such as mindful breathing and body awareness. Initial focus on inner resources such as positive memories, imagining a safe place and the use of the music breathing technics.

Being tested
Receptive music therapy, Psychological treatment
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 Modified Guided Imagery and Music

    16 sessions of a length of one hour comprising of receptive music psychotherapy with 5 - 15 minutes of music listening included

  • Psychological treatmentBehavioural

    16 sessions of a length of one hour comprising of verbal based psychotherapy based on principles from Narrative Exposure Therapy or Cognitive Behavioral Therapies

Study groups in NCT02874235
Study groupRoleWhat they receive
Music therapy treatmentExperimental35 patients receiving each 16 sessions of Receptive music therapy
Receives: Behavioral: Receptive music therapy
Standard treatmentActive comparator35 patients receiving each 16 sessions of Psychological treatment
Receives: Behavioral: Psychological treatment

What is being measured

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

  1. Change in HTQ-R

    DSM IV PTSD symptoms part (first 16 items) of section 4 of HTQ. the Harvard Trauma Questionnaire is a 4 point Likert scale. Scored during an interview with an external psychologist blinded to the treatment group. Measured at baseline, post-treatment and at 6 months follow up.

    Measured: 6 months

  2. Change in PTSD-8

    DSM IV PTSD symptoms (8 of the first 16 items) of section 4 of HTQ. The Harvard Trauma Questionnaire is a Likert 4 point scale. PTSD is scored by the patient two times during treatment before session 4 and 12. This measure is also a part of the HTQ-R (Outcome 1)

    Measured: 6 months

Secondary outcomes (7)

  1. Change in WHO-5

    WHO-5 Quality of Life Scale, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.

    Measured: 6 months

  2. Change in RAAS

    Revised Adult Attachment Scale. Attachment in close relationship self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.

    Measured: 6 months

  3. Change in DSS

    Dissociation Symptom Scale, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.

    Measured: 6 months

  4. Change in SDQ-20

    Somatoform Dissociation Questionnaire, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.

    Measured: 6 months

  5. Change in Oxytocin

    Oxytocin collected in saliva. Measured at baseline, post-treatment and at 6 months follow up and. pre- and post session in the third or fourth session and second or third last session.

    Measured: 6 months

  6. Change in Beta-endorphin

    Beta-endorphin collected in saliva. Measured at baseline, post-treatment and at 6 months follow up and pre- and post session in the third or fourth session and second or third last session.

    Measured: 6 months

  7. Change in Substance P

    Substance P collected in saliva. Measured at baseline, post-treatment and at 6 months follow up and pre- and post session in the third or fourth session and second or third last session.

    Measured: 6 months

Timeline

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

  1. First posted22 Aug 2016 (estimated)
  2. Study start9 May 2016
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2019

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02874235
Sponsor's protocol ID
SJ-529
Acronym
RCT-KTF
Status last verified
Jun 2020
First submitted
28 Jun 2016
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Alanne, S. (2010). Music Psychotherapy with Refugee Survivors of Torture: Interpretations of Three Clinical Case Studies. Sibelius Academy.

  • Alluri V, Toiviainen P, Jaaskelainen IP, Glerean E, Sams M, Brattico E. Large-scale brain networks emerge from dynamic processing of musical timbre, key and rhythm. Neuroimage. 2012 Feb 15;59(4):3677-89. doi: 10.1016/j.neuroimage.2011.11.019. Epub 2011 Nov 12.

    PubMed 22116038

  • Beck, B. D., & Mumm, H. (2015). Forskning i musikterapi - posttraumatisk stressbelastning (PTSD). Dansk Musikterapi, 12(1). Retrieved from http://vbn.aau.dk/en/publications/forskning-i-musikterapi--posttraumatisk-stressbelastning-ptsd(9a7b99e6-ce28-451e-aad3-b0dbb63fff07).html

  • Blake, R. L., & Bishop, S. R. (1994). 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. http://doi.org/10.1093/mtp/12.2.125

  • Koelsch S. Towards a neural basis of music-evoked emotions. Trends Cogn Sci. 2010 Mar;14(3):131-7. doi: 10.1016/j.tics.2010.01.002. Epub 2010 Feb 10.

    PubMed 20153242

  • Herholz SC, Halpern AR, Zatorre RJ. Neuronal correlates of perception, imagery, and memory for familiar tunes. J Cogn Neurosci. 2012 Jun;24(6):1382-97. doi: 10.1162/jocn_a_00216. Epub 2012 Feb 23.

    PubMed 22360595

  • Bruscia, K. E. (2002). Guided Imagery and Music: The Bonny Method and Beyond. Barcelona Publishers.

  • Bonny, H. L. (2002). Music Consciousness: The Evolution of Guided Imagery and Music. (L. Summer, Ed.). Gilsum, NH: Barcelona Publishers.

  • Körlin, D., Nybäck, H., & Goldberg, F. S. (2000). Creative arts groups in psychiatric care Development and evaluation of a therapeutic alternative. Nordic Journal of Psychiatry, 54(5), 333-340.

  • Kraus N, Zatorre RJ, Strait DL. Editors' introduction to Hearing Research special issue: music: a window into the hearing brain. Hear Res. 2014 Feb;308:1. doi: 10.1016/j.heares.2013.09.013. No abstract available.

    PubMed 24571003

  • Maack, C. (2012). Outcomes and Processes of the Bonny Method of Guided Imagery and Music (GIM) and its Adaptations and Psychodynamic Imaginative Trauma Therapy (PITT) for Women with Complex PTSD. Aalborg University Denmark 2012. Retrieved from http://gim-therapie.de/Thesis.pdf

  • Moe, T. (2001). Restituerende faktorer i gruppemusikterapi med psykiatriske patienter - baseret på en modifikation af Guided imagery and Music (GIM) (PhD Thesis). Aalborg University Denmark. Retrieved from http://www.wfmt.info/Musictherapyworld/modules/archive/dissertations/pdfs/TorbenM.pdf

Questions about this trial

What is this clinical trial studying?

A study testing Receptive music therapy and Psychological treatment in people with Stress Disorders, Post-Traumatic, run by Psychiatric Research Unit, Region Zealand, Denmark.

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 3 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 11 Jun 2020. 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 in HTQ-R (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02874235, which also lists 12 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 11 Jun 2020.

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