Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation

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ClinicalTrials.gov Identifier: NCT00137189

Recruitment Status : Completed

First Posted : August 29, 2005

Last Update Posted : May 15, 2017

Sponsor:

Collaborators:

The Research Council of Norway

Helse Vest

Helse Forde

Nordfjord Psychiatric Centre

Helse Stavanger HF

Jæren District Psychiatric Centre

The Wagner-Jauregg Provincial Neuropsychiatric Clinic

University of Melbourne

Information provided by (Responsible Party):

NORCE Norwegian Research Centre AS

Tracking Information

First Submitted Date ^ICMJE

August 26, 2005

First Posted Date ^ICMJE

August 29, 2005

Last Update Posted Date

May 15, 2017

Study Start Date ^ICMJE

April 2005

Actual Primary Completion Date

October 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

negative symptoms (Scale for the Assessment of Negative Symptoms [SANS]) [ Time Frame: 1 ]
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS]) [ Time Frame: 3 months ]
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS]) [ Time Frame: 9 months ]

Original Primary Outcome Measures ^ICMJE

negative symptoms (SANS scale) at 1, 3, and 9 months

Change History

Current Secondary Outcome Measures ^ICMJE

general symptoms [ Time Frame: 1 ]
general symptoms [ Time Frame: 3 months ]
general symptoms [ Time Frame: 9 months ]
general functioning [ Time Frame: 1 months ]
general functioning [ Time Frame: 3 months ]
general functioning [ Time Frame: 9 months ]
clinical global impressions [ Time Frame: 1 months ]
clinical global impressions [ Time Frame: 3 months ]
clinical global impressions [ Time Frame: 9 months ]
interest in music [ Time Frame: 1 months ]
interest in music [ Time Frame: 3 months ]
interest in music [ Time Frame: 9 months ]
motivation for change [ Time Frame: 1 months ]
motivation for change [ Time Frame: 3 months ]
motivation for change [ Time Frame: 9 months ]
self-efficacy [ Time Frame: 1 months ]
self-efficacy [ Time Frame: 3 months ]
self-efficacy [ Time Frame: 9 months ]
self-esteem [ Time Frame: 1 months ]
self-esteem [ Time Frame: 3 months ]
self-esteem [ Time Frame: 9 months ]
vitality [ Time Frame: 1 months ]
vitality [ Time Frame: 3 months ]
vitality [ Time Frame: 9 months ]
affect regulation [ Time Frame: 1 months ]
affect regulation [ Time Frame: 3 months ]
affect regulation [ Time Frame: 9 months ]
relational competence [ Time Frame: 1 months ]
relational competence [ Time Frame: 3 months ]
relational competence [ Time Frame: 9 months ]
actual social relationships [ Time Frame: 1 months ]
actual social relationships [ Time Frame: 3 months ]
actual social relationships [ Time Frame: 9 months ]

Original Secondary Outcome Measures ^ICMJE

general symptoms
general functioning
clinical global impressions
interest in music
motivation for change
self-efficacy
self-esteem
vitality
affect regulation
relational competence
actual social relationships
(all with specific scales at 1, 3, and 9 months)

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation

Official Title ^ICMJE

Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation: A Randomised Controlled Trial

Brief Summary

The aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes.

Detailed Description

Background: Previous research has shown positive effects of music therapy for people with schizophrenia and other mental disorders. In clinical practice, music therapy is often offered to psychiatric patients with low therapy motivation, but little research exists about this population. The aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes. An additional aim of the study is to examine the mechanisms of change through music therapy.

Method: 144 adults with a non-organic mental disorder (ICD-10: F1 to F6) who have low therapy motivation and a willingness to work with music will be randomly assigned to an experimental or a control condition. All participants will receive standard care, and the experimental group will in addition be offered biweekly sessions of music therapy over a period of three months. Outcomes will be measured by a blind assessor before and 1, 3, and 9 months after randomisation.

Discussion: The findings to be expected from this study will fill an important gap in the knowledge of treatment effects for a patient group that does not easily benefit from treatment. The study's close link to clinical practice, as well as its size and comprehensiveness, will make its results well generalisable to clinical practice.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Mental Disorders
Mood Disorders
Personality Disorders
Schizophrenia and Disorders With Psychotic Features

Intervention ^ICMJE

Procedure: Resource-oriented music therapy
Procedure: Standard care

Study Arms ^ICMJE

Experimental: Music therapy
See published study protocol
Interventions:
- Procedure: Resource-oriented music therapy
- Procedure: Standard care
Standard care
See published study protocol

Intervention: Procedure: Standard care

Publications *

Rolvsjord R, Gold C, Stige B. Research rigour and therapeutic flexibility: Rationale for a therapy manual developed for a randomised controlled trial. Nordic Journal of Music Therapy 14(1):15-32, 2005.
Gold C, Rolvsjord R, Aaro LE, Aarre T, Tjemsland L, Stige B. Resource-oriented music therapy for psychiatric patients with low therapy motivation: protocol for a randomised controlled trial [NCT00137189]. BMC Psychiatry. 2005 Oct 31;5:39.
Gold C, Mössler K, Grocke D, Heldal TO, Tjemsland L, Aarre T, Aarø LE, Rittmannsberger H, Stige B, Assmus J, Rolvsjord R. Individual music therapy for mental health care clients with low therapy motivation: multicentre randomised controlled trial. Psychother Psychosom. 2013;82(5):319-31. doi: 10.1159/000348452. Epub 2013 Aug 9.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

144

Original Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

October 2010

Actual Primary Completion Date

October 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Non-organic mental disorder
Low therapy motivation
Willingness to work with music

Exclusion Criteria:

Severe mental retardation
Life-threatening somatic illness

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Austria, Norway

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00137189

Other Study ID Numbers ^ICMJE

RCT-MTPSY

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Responsible Party

NORCE Norwegian Research Centre AS

Study Sponsor ^ICMJE

NORCE Norwegian Research Centre AS

Collaborators ^ICMJE

The Research Council of Norway
Helse Vest
Helse Forde
Nordfjord Psychiatric Centre
Helse Stavanger HF
Jæren District Psychiatric Centre
The Wagner-Jauregg Provincial Neuropsychiatric Clinic
University of Melbourne

Investigators ^ICMJE

Principal Investigator:	Christian Gold, PhD	Grieg Academy Music Therapy Research Centre GAMUT, Unifob Health
Study Director:	Brynjulf Stige, PhD	University of Bergen/Grieg Academy Music Therapy Research Centre GAMUT, Unifob Health

PRS Account

NORCE Norwegian Research Centre AS

Verification Date

May 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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