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Music Therapy and Treatment as Usual

NCT02874235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-06-11

No results posted yet for this study

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

Interventions

BEHAVIORAL

Receptive music therapy

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

BEHAVIORAL

Psychological treatment

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

Sponsors & Collaborators

  • Det Obelske Familiefond

    collaborator UNKNOWN

  • Aalborg University

    collaborator OTHER

  • University of Aarhus

    collaborator OTHER

  • Psychiatric Research Unit, Region Zealand, Denmark

    lead OTHER

Principal Investigators

  • Torben Moe, Ph.D. · Research Unit, Region Zealand Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-09
Primary Completion
2019-11-30
Completion
2019-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02874235 on ClinicalTrials.gov