Music Therapy and Treatment as Usual (RCT-KTF)

June 10, 2020 updated by: Psychiatric Research Unit, Region Zealand, Denmark

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music therapy treatment
35 patients receiving each 16 sessions of Receptive music therapy
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
Other Names:
  • Modified Guided Imagery and Music
Active Comparator: Standard treatment
35 patients receiving each 16 sessions of Psychological treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HTQ-R
Time Frame: 6 months
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
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in WHO-5
Time Frame: 6 months
WHO-5 Quality of Life Scale, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.
6 months
Change in RAAS
Time Frame: 6 months
Revised Adult Attachment Scale. Attachment in close relationship self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.
6 months
Change in DSS
Time Frame: 6 months
Dissociation Symptom Scale, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.
6 months
Change in SDQ-20
Time Frame: 6 months
Somatoform Dissociation Questionnaire, self-report questionnaire. Measured at baseline, post-treatment and at 6 months follow up.
6 months
Change in Oxytocin
Time Frame: 6 months
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.
6 months
Change in Beta-endorphin
Time Frame: 6 months
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.
6 months
Change in Substance P
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Psychiatric Research Unit, Region Zealand, Denmark

Collaborators

University of Aarhus
Aalborg University
Det Obelske Familiefond

Investigators

  • Study Director: Torben Moe, Ph.D., Research Unit, Region Zealand Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2016

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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