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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
 (submitted: May 12, 2017)
  • 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
 (submitted: August 26, 2005)
negative symptoms (SANS scale) at 1, 3, and 9 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
  • 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
 (submitted: August 26, 2005)
  • 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 *

*   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
 (submitted: August 26, 2005)
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 No
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 No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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