AzTrials
AzTrials

Mental DisordersNCT00137189

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

A study testing Resource-oriented music therapy in people with Mental Disorders and Mood Disorders, run by NORCE Norwegian Research Centre AS at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resource-oriented music therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
5 sitesin 3 countries
Study dates
Apr 2005to Oct 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Severe mental retardation
  • Life-threatening somatic illness

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Norway3 sites

  • Jæren District Psychiatric Centre

    Bryne, Rogaland, 4349

  • Nordfjord Psychiatry Centre

    Nordfjordeid, Sogn Og Fjordane, 6770

  • Stavanger University Hospital

    Stavanger, Rogaland, 4068

Other trials in Norway

Australia1 site

  • Sunshine Hospital/University of Melbourne, Faculty of Music

    Melbourne

Other trials in Australia

Austria1 site

  • Wagner Jauregg Hospital

    Linz, 4021

Other trials in Austria

About this study

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

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.

Read the 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.

Being tested
Resource-oriented music therapy, Standard care
Keywords
Motivation, Music Therapy, Psychotherapy
Medical subject headings
Mental Disorders, Mood Disorders, Personality Disorders, Schizophrenia Spectrum and Other Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resource-oriented music therapyProcedure or surgery

  • Standard careProcedure or surgery

Study groups in NCT00137189
Study groupRoleWhat they receive
Music therapyExperimentalSee published study protocol
Receives: Procedure: Resource-oriented music therapy; Procedure: Standard care
Standard careOtherSee published study protocol
Receives: Procedure: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])

    Measured: 1

  2. negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])

    Measured: 3 months

  3. negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])

    Measured: 9 months

Secondary outcomes (33)

  1. general symptoms

    Measured: 1

  2. general symptoms

    Measured: 3 months

  3. general symptoms

    Measured: 9 months

  4. general functioning

    Measured: 1 months

  5. general functioning

    Measured: 3 months

  6. general functioning

    Measured: 9 months

  7. clinical global impressions

    Measured: 1 months

  8. clinical global impressions

    Measured: 3 months

  9. clinical global impressions

    Measured: 9 months

  10. interest in music

    Measured: 1 months

  11. interest in music

    Measured: 3 months

  12. interest in music

    Measured: 9 months

  13. motivation for change

    Measured: 1 months

  14. motivation for change

    Measured: 3 months

  15. motivation for change

    Measured: 9 months

  16. self-efficacy

    Measured: 1 months

  17. self-efficacy

    Measured: 3 months

  18. self-efficacy

    Measured: 9 months

  19. self-esteem

    Measured: 1 months

  20. self-esteem

    Measured: 3 months

  21. self-esteem

    Measured: 9 months

  22. vitality

    Measured: 1 months

  23. vitality

    Measured: 3 months

  24. vitality

    Measured: 9 months

  25. affect regulation

    Measured: 1 months

  26. affect regulation

    Measured: 3 months

  27. affect regulation

    Measured: 9 months

  28. relational competence

    Measured: 1 months

  29. relational competence

    Measured: 3 months

  30. relational competence

    Measured: 9 months

  31. actual social relationships

    Measured: 1 months

  32. actual social relationships

    Measured: 3 months

  33. actual social relationships

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00137189
Sponsor's protocol ID
RCT-MTPSY
Status last verified
May 2017
First submitted
26 Aug 2005
Last updated
15 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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. doi: 10.1186/1471-244X-5-39.

    PubMed 16259626

  • Gold C, Mossler K, Grocke D, Heldal TO, Tjemsland L, Aarre T, Aaro 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.

    PubMed 23942318

Questions about this trial

What is this clinical trial studying?

A study testing Resource-oriented music therapy in people with Mental Disorders and Mood Disorders, run by NORCE Norwegian Research Centre AS at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Norway, Australia, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

negative symptoms (Scale for the Assessment of Negative Symptoms [SANS]) (time frame: 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00137189, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in