NCT02942459

Brief Summary

The Aim of this National study is to examine whether music therapy can reduce negative symptoms and raise Quality of Life for patients suffering from Schizophrenia. It is an Randomized Controlled Trial (RCT), double-blinded study with two arms. 120 Participants are anticipated. The two Arms consist of 25 weekly hours of Music Therapy by educated Music Therapists and time compensated Music Listening by unknown Care Staff Members. The Study is a close Cooperation between Aalborg University (The Music Therapy Research Clinic) and Aalborg University Hospital, Psychiatry.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

4.6 years

First QC Date

September 20, 2016

Last Update Submit

July 4, 2019

Conditions

Schizophrenia

Keywords

music therapydouble-blindedRandomized Controlled study (RCT)Schizophrenia, negative symptoms

Outcome Measures

Primary Outcomes (1)

  • Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires

    The Positive and Negative Syndrome Scale (PANSS). Negative Subscale.

    Up til 30 weeks

Secondary Outcomes (3)

  • Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire

    Up till 30 weeks

  • Functional Changes from Baseline to Termination. Psychological Questionnaire

    Up to 30 weeks

  • Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire

    Up to 30 weeks

Study Arms (2)

Music Therapy

EXPERIMENTAL

25 Weekly Hours of Music Therapy adapted to the Needs of the Participants. Interventions can be Active (playing Music, singing, improvising, Song-writing) or Receptive (Listening to selected Play-lists, or to the Participants´ favored Music). A Manual is created and trained with the Music Therapists, which distinguishes between 1. Unique and Essential Principles for Music Therapy with people suffering from Schizophrenia with negative Symptoms, 2. Essential but not Unique Principles, 3. Acceptable but not necessary Principles, 4. Not acceptable and Proscribed Principles. These Principles concern Attitude and Listening Perspectives by the Music Therapist, how to conduct the Musical Interventions and Questions of Frames for the Music Therapy Work.

Other: Music therapy

Music Listening

ACTIVE COMPARATOR

25 Weekly Hours of Being together with an unknown Care Staff Member listening to Music from selected Play-Lists. Music Therapists at the Music Therapy Research Clinic at Aalborg University Hospital, Psychiatry have developed Play-Lists in a Taxonomy from very Supportive to less Supportive Music including around 100 Hours of Music all together on the Lists. A Manual is created and trained with the Care Staff Members. Here the Activities are much more limited (only Music Listening to the Play-Lists are allowed). No Therapeutical Conversation is allowed.

Other: Music Listening

Interventions

Music therapyOTHER

25 Weekly Hours of Music Therapy by an Educated Music Therapist

Music Therapy
Music ListeningOTHER

25 weekly Hours of Being Together with an unknown Care Staff Member

Music Listening

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • A Diagnosis of Schizophrenia International Classification of Diseases (ICD-10 (F20))
  • The Positive and Negative Syndrome Scale (PANNS), negative subscale has to show ≥ 4 on two of the following parameters:
  • (N1) subdued affect, (N2) emotional withdrawal, (N3) poor contact and (N4) passive/apathetic social withdrawal.

You may not qualify if:

  • Debut of schizophrenia less than 2 years ago.
  • Patients in acute worsening of schizophrenia defined as hospitalization within the last three months.
  • PANNS positive subscale (P1-P7) \>28.
  • Patients who have their psychotropics changed within the last months.
  • Significant drug dependency conflicting participation in the study.
  • Presence of secondary symptoms defined as Depression - CDSS score \> 7
  • Neurological side effects - UKU score \> 1 in one of the following items: 2.1, 2.2, 2.3, 2.5, 2.6
  • Sedative side effects - UKU item 1.3 score \> 1.
  • No individual music therapy within the last two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, North Jutland, 9000, Denmark

RECRUITING

Related Publications (2)

  • Hannibal N, Pedersen IN, Bertelsen LR, Nielsen RE, Gold C. Process-outcome relations in music therapy versus music listening for people with schizophrenia viewed through a mediational model: the role of the therapeutic alliance. Front Psychiatry. 2023 May 2;14:1120003. doi: 10.3389/fpsyt.2023.1120003. eCollection 2023.

    PMID: 37200903DERIVED

  • Pedersen IN, Bonde LO, Hannibal NJ, Nielsen J, Aagaard J, Gold C, Rye Bertelsen L, Jensen SB, Nielsen RE. Music Therapy vs. Music Listening for Negative Symptoms in Schizophrenia: Randomized, Controlled, Assessor- and Patient-Blinded Trial. Front Psychiatry. 2021 Dec 21;12:738810. doi: 10.3389/fpsyt.2021.738810. eCollection 2021.

    PMID: 34992553DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Inge N. Pedersen, Ass. Prof.

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Inge N. Pedersen, PhDAss. Prof

CONTACT

+45 26229614innp@rn.dk

René Ernst Nielsen, PhDAss.Prof

CONTACT

+45 28722962ren@rn.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Professor. PhD

Study Record Dates

First Submitted

September 20, 2016

First Posted

October 24, 2016

Study Start

September 1, 2015

Primary Completion

April 1, 2020

Study Completion

December 31, 2020

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)