Clinical trial NCT02874235: Music Therapy and Treatment as Usual
Official title: Music Therapy Versus Treatment as Usual: A Randomized Non-inferiority Study With Traumatized Refugees Diagnosed With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Sponsor class: OTHER
Collaborators: name: Det Obelske Familiefond
name: Aalborg University
name: University of Aarhus
First posted: 2016-08-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in HTQ-R
timeFrame: 6 months
measure: Change in PTSD-8
timeFrame: 6 months
Secondary outcomes:
measure: Change in WHO-5
timeFrame: 6 months
measure: Change in RAAS
timeFrame: 6 months
measure: Change in DSS
timeFrame: 6 months
measure: Change in SDQ-20
timeFrame: 6 months
measure: Change in Oxytocin
timeFrame: 6 months
measure: Change in Beta-endorphin
timeFrame: 6 months
measure: Change in Substance P
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Research Unit, Region Zealand Denmark
name: Torben Moe, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Alanne, S. (2010). Music Psychotherapy with Refugee Survivors of Torture: Interpretations of Three Clinical Case Studies. Sibelius Academy.
citation: 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.
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: Bruscia, K. E. (2002). Guided Imagery and Music: The Bonny Method and Beyond. Barcelona Publishers.
citation: Bonny, H. L. (2002). Music Consciousness: The Evolution of Guided Imagery and Music. (L. Summer, Ed.). Gilsum, NH: Barcelona Publishers.
citation: 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.
citation: 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.
citation: 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
citation: 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