SchizophreniaNCT02942459
Music Therapy Towards Schizophrenia, Negative Symptoms
A study testing Music therapy and Music Listening in people with Schizophrenia, run by Inge Nygaard Pedersen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Music therapy and Music Listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2015to 31 Dec 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 65 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, North Jutland, 9000
Inge N. Pedersen, PhDAss. Prof, +45 26229614, innp@rn.dk
René Ernst Nielsen, PhDAss. Prof, +45 28722962, ren@rn.dk
About this study
Official title: Music Therapy for Treatment of Patients Suffering From Schizophrenia With Negative Symptoms - A Double-blinded Study
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.
Read the detailed description
Schizophrenia includes 1 % of the Population in Denmark (DK) and often ends up to be chronically. Negative Symptoms are difficult to reduce by Medication and Psychosocial Treatment Possibilities are searched for. Three Cochrane Reviews (2005, 2011, 2017) have been conducted concerning Music Therapy and Schizophrenia with Positive Results. This RCT, double-blinded Study aims at verifying, if these Results can be Recognized in the Danish Health System. It also aims at being similar to Biomedical Study Designs as much as possible to strengthen the Evidence of the Study. A Power Calculation showed, that a minimum of 44,5 Participants in each Arm should be available, but as drop out can be anticipated with this Population, 60 Participants in each Arm were recommended. The screening Procedure is Comprehensive as it aims at securing, that the negative Symptoms are part of the Illness Schizophrenia and not side Effects from Medication or simultaneous Depression (See the Inclusion- and Exclusion criteria).
The Measurement Tools are as follows:
At Baseline, after 15 Sessions and at Termination:
- The Positive and Negative Syndrome Scale (PANSS),
- Brief Negative Symptom Scale (BNSS),
- Quality of Life (WHOQOL-Bref),
- Calgary Depression Scale for Schizophrenia (CDSS),
- Board of Clinical Examinations (Danish Questionnaire) (UKU)
- Global Assessment of Functioning Scale (GAF) 4 Weeks after Termination Follow Up Interview. In the Arm of Music Therapy Audio Recording of Music Interventions are done in Session 1,15 and 25.
- Helping Alliance Questionnaire, patient version, (Haq-II) This Haq-II is filled out after 5 sessions and after 15 Sessions and at Termination together with a Research Assistant in both Arms.
- Conditions
- Schizophrenia
- Being tested
- Music therapy, Music Listening
- Keywords
- music therapy, double-blinded, Randomized Controlled study (RCT), Schizophrenia, negative symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
25 Weekly Hours of Music Therapy by an Educated Music Therapist
Music ListeningOther
25 weekly Hours of Being Together with an unknown Care Staff Member
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires
The Positive and Negative Syndrome Scale (PANSS). Negative Subscale.
Measured: Up til 30 weeks
Secondary outcomes (3)
Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire
Quality of Life (WHOQOL-Bref)
Measured: Up till 30 weeks
Functional Changes from Baseline to Termination. Psychological Questionnaire
Global Assessment of Functioning (GAF)
Measured: Up to 30 weeks
Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire
Brief negative Symptom Scale (BNSS). Anhedonic Subscale.
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start1 Sep 2015
- Primary completion1 Apr 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inge Nygaard Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor-investigator, Inge Nygaard Pedersen, Aalborg Psychiatric Hospital
- Investigators
- Inge N. Pedersen, Ass. Prof., Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942459
- Sponsor's protocol ID
- N-20150054
- Status last verified
- Jul 2019
- First submitted
- 20 Sep 2016
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37200903Pedersen 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.
PubMed 34992553
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy for Treatment of Patients Suffering From Schizophrenia With Negative Symptoms - A Double-blinded Study
- ClinicalTrials.gov ID
- NCT02942459
- Acronym / sponsor ID
- N-20150054
- Conditions
- Schizophrenia
- Keywords
- music therapy, double-blinded, Randomized Controlled study (RCT), Schizophrenia, negative symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Inge Nygaard PedersenUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Schizophrenia includes 1 % of the Population in Denmark (DK) and often ends up to be chronically. Negative Symptoms are difficult to reduce by Medication and Psychosocial Treatment Possibilities are searched for. Three Cochrane Reviews (2005, 2011, 2017) have been conducted concerning Music Therapy and Schizophrenia with Positive Results. This RCT, double-blinded Study aims at verifying, if these Results can be Recognized in the Danish Health System. It also aims at being similar to Biomedical Study Designs as much as possible to strengthen the Evidence of the Study. A Power Calculation showed, that a minimum of 44,5 Participants in each Arm should be available, but as drop out can be anticipated with this Population, 60 Participants in each Arm were recommended. The screening Procedure is Comprehensive as it aims at securing, that the negative Symptoms are part of the Illness Schizophrenia and not side Effects from Medication or simultaneous Depression (See the Inclusion- and Exclusion criteria).
The Measurement Tools are as follows:
At Baseline, after 15 Sessions and at Termination:
- The Positive and Negative Syndrome Scale (PANSS),
- Brief Negative Symptom Scale (BNSS),
- Quality of Life (WHOQOL-Bref),
- Calgary Depression Scale for Schizophrenia (CDSS),
- Board of Clinical Examinations (Danish Questionnaire) (UKU)
- Global Assessment of Functioning Scale (GAF) 4 Weeks after Termination Follow Up Interview. In the Arm of Music Therapy Audio Recording of Music Interventions are done in Session 1,15 and 25.
- Helping Alliance Questionnaire, patient version, (Haq-II) This Haq-II is filled out after 5 sessions and after 15 Sessions and at Termination together with a Research Assistant in both Arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: Music therapy25 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. |
| Music Listening | Active comparator | Other: Music Listening25 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 65 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy25 Weekly Hours of Music Therapy by an Educated Music Therapist | Other | Music Therapy |
| Music Listening25 weekly Hours of Being Together with an unknown Care Staff Member | Other | Music Listening |
Primary outcome
Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires
Time frame: Up til 30 weeks
The Positive and Negative Syndrome Scale (PANSS). Negative Subscale.
3 secondary outcomes
Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire
Time frame: Up till 30 weeks
Functional Changes from Baseline to Termination. Psychological Questionnaire
Time frame: Up to 30 weeks
Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire
Time frame: Up to 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Derived from this study: PubMed 37200903Hannibal 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.
- Derived from this study: PubMed 34992553Pedersen 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.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inge N. Pedersen, Ass. Prof. principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy and Music Listening in people with Schizophrenia, run by Inge Nygaard Pedersen at 1 site in Denmark.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inge N. Pedersen, PhDAss. Prof (+45 26229614, innp@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires (time frame: Up til 30 weeks). 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 NCT02942459, which also lists 2 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 8 Jul 2019.