Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT02874235
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Therapy and Treatment as Usual
Sponsor:
Psychiatric Research Unit, Region Zealand, Denmark
Organization:
Study Overview
Official Title:
Music Therapy Versus Treatment as Usual: A Randomized Non-inferiority Study With Traumatized Refugees Diagnosed With PTSD
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT-KTF
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: