Music Therapy and Treatment as Usual

NCT02874235 | Completed

• 1 other identifier: SJ-529
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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)

  6 months

Secondary Outcomes (7)

• Change in WHO-5

  6 months

• Change in RAAS

  6 months

• Change in DSS

  6 months

• Change in SDQ-20

  6 months

• Change in Oxytocin

  6 months

Study Arms (2)

Music therapy treatment

EXPERIMENTAL

35 patients receiving each 16 sessions of Receptive music therapy

Behavioral: Receptive music therapy

Standard treatment

ACTIVE COMPARATOR

35 patients receiving each 16 sessions of Psychological treatment

Behavioral: Psychological treatment

Interventions

Receptive music therapy BEHAVIORAL

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

Also known as: Modified Guided Imagery and Music

Music therapy treatment

Psychological treatment BEHAVIORAL

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

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead
• Det Obelske Familiefond: collaborator
• Aalborg University: collaborator
• University of Aarhus: collaborator

Related Publications (12)

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

  BACKGROUND

• 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.

  PMID: 22116038 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20153242 BACKGROUND

• 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.

  PMID: 22360595 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24571003 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Torben Moe, Ph.D.

  Research Unit, Region Zealand Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: External psychologist performs primary outcome measurement not knowing participants treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: August 22, 2016
• Study Start: May 9, 2016
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share