Condition category
Mental and Behavioural Disorders
Date applied
24/01/2018
Date assigned
26/01/2018
Last edited
26/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression is among the leading causes of disability worldwide. Not all people with depression respond adequately to standard treatments. An innovative therapy that has shown promising results in controlled trials is music therapy. Based on a previous trial that suggested beneficial effects of Integrative Improvisational Music Therapy (IIMT) on short- and medium term depression symptoms as well as anxiety and functioning, this trial aims to determine potential mechanisms and enhancements of its effects by examining specific variations to IIMT.

Who can participate?
Adults aged 18–65 years of age with a primary diagnosis of depression.

What does the study involve?
All participants receive 6 weeks of biweekly IIMT, where they are invited to improvise music and reflect on those improvisations with a music therapist in a one-to-one setting. Potential enhancements to IIMT include: home-based listening to recorded improvisations from IIMT sessions to facilitate integration of therapeutic processing into daily life; and resonance frequency breathing, a breathing exercise at the beginning of each session to facilitate emotional expression and processing.

What are the possible benefits and risks of participating?
Decrease of depression scores is expected in all groups, as IIMT as such is already known to be effective in the treatment of depression. Participants in the added treatment conditions are expected to improve more than the ones receiving only traditional IIMT. Participation in therapy is likely to trigger difficult emotions, yet this is considered to be a normal part of therapy and known to be beneficial for recovery.

Where is the study run from?
The study is run at the music therapy clinic of the Department of Music, Art and Culture Studies at the University of Jyväskylä, Finland.

When is study starting and how long is it expected to run for?
June 2016 to July 2020

Who is the main contact?
prof. Jaakko Erkkilä
jaakko.erkkila@jyu.fi

Trial website

https://www.jyu.fi/hytk/fi/laitokset/mutku/tutkimus/tutkimusprojektit/no-pain-no-gain

Contact information

Type

Scientific

Primary contact

Prof Jaakko Erkkilä

ORCID ID

http://orcid.org/0000-0003-1130-837X

Contact details

Department of Music
Art and Culture Studies
University of Jyväskylä
P.O. Box 35
Jyväskylä
40014
Finland
+358 400 542395
jaakko.erkkila@jyu.fi

Type

Public

Additional contact

Mr Markku Pöyhönen

ORCID ID

Contact details

Department of Music
Art and Culture Studies
University of Jyväskylä
P.O. Box 35
Jyväskylä
40014
Finland
+358 405 707007
markku.i.poyhonen@jyu.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

298678

Study information

Scientific title

No pain no gain: Internal mechanisms of Integrative Improvisational Music Therapy in the treatment of depression

Acronym

NPNG

Study hypothesis

Based on previous research, Integrative Improvisational Music Therapy (IIMT) has been shown to be effective in the treatment of depression. In this study we hypothesize that the outcome of IIMT used for depression can be improved by the addition of two elements: listening back at home to improvisations created during therapy (listening homework) and starting the sessions with Resonance Frequency Breathing (RFB).

Ethics approval

Ethical board of the Central Finland health care district, 07/09/2017, ref: 17U/2017

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Depression with or without co-morbid anxiety.

Intervention

The trial uses a 2x2 factorial design, in which the conditions are derived from either the presence or non-presence of listening back to improvisations (listening homework) and Resonance Frequency Breathing (RFB). All groups receive IIMT. In addition, one treatment group receives listening homework (LH) as an additional component, the second treatment group receives RFB as an additional component, and the third treatment group receives both of these as an additional component.

All the four groups are offered IIMT as usual. Similarly, all the groups are equal in terms of frequency of sessions (bi-weekly), number of therapy sessions (12), length of sessions (60 minutes). The total length of the therapy processes in each groups is about 6 weeks. The follow-up for each of the groups takes place at 6 months from the ending of the therapy.

Group 1: Integrative Improvisational Music Therapy (IIMT); 12 bi-weekly sessions, 60 minutes each; delivered by qualified music therapists;
Improvisational Integrative Music Therapy (IIMT) is a treatment model developed at our site (Department of Music, Art and Culture studies, University of Jyväskylä, Finland). IIMT consists of a) 5 to 10 minutes of initial discussion, b) improvising (clinical improvisation) in client-therapist dyad with easily approachable instruments (djembe drums and digital keyboards), and c) discussing the experiences triggered by the improvisations. In IIMT, the number and length of the improvisations vary depending on the client’s situation and the phase of the therapy process. Occasionally, clients may have difficulties to verbalize their experiences, in which case the interaction may rely more on music (improvising). It may also be the other way around, whereby a client has a strong need to verbalize his/her musical experiences, thus creating less room for music. Thus, though based on a single music therapy technique (clinical improvisation), IIMT offers flexibility as well.

Group 2: IIMT as above plus listening homework (LH) between sessions
LH combines music making (clinical improvisation) and music listening (listening back to the recorded clinical improvisations). Based on clinical experience and literature both from music psychology and music therapy fields, we assume that when combined in this way, these interventions have mutually complementary effect on therapeutic processing. LH may particularly promote the self-reflective processing of the emotions and personal experiences expressed through the improvisation.

Group 3: IIMT as above plus Resonance Frequency Breathing (RFB), at the beginning of each IIMT session
RFB consists in slow breathing at someone's resonance frequency, which is the frequency that maximises HRV. This typically happens around six breaths/min. RFB instantly reduces people’s stress levels by shifting the autonomic nervous system towards parasympathetic (rest-and-digest) dominance. Since the optimal breathing speed under which resonance is achieved is different from person to person, it needs to be established on an individual basis through a breathing assessment.

Group 4: IIMT as above plus LH and RFB as above.

Participants are assessed before the intervention, six weeks after the intervention and attend a 12 month follow up/

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Depression is measured using the MADRS (Montgomery-Åsberg Depression Rating Scale)at baseline, six weeks and 12 months

Secondary outcome measures

1. Anxiety is measured using Hospital Anxiety and Depression Scale at baseline, six weeks and 12 months
2. Quality of Life is measured using RAND-36 at baseline, six weeks and 12 months
3. Functioning is measured using Global Assessment of Functioning (GAF) at baseline, six weeks and 12 months
4. Self-perceived depression levels are measured using a clinician questionnaire at each session of the intervention

Overall trial start date

01/08/2016

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participants must have depression as their primary diagnosis, according to the categories F32 or F33 of the ICD-10
2. Ager range: 18-65 years
3. Gender: Both
4. If diagnosed alongside the depression, anxiety will also be included, as both pathologies present a high level of co-morbidity
5. Musical skills or any form of musical background are not required; their presence, however, does not constitute a reason for exclusion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

68

Participant exclusion criteria

1. Psychosis
2. Combinations of psychiatric disorders in which depression cannot be defined as the primary disorder
3. Acute and severe substance misuse
5. Severe depression preventing the clients from participating in the measurements or engaging in verbal conversation

Recruitment start date

01/02/2018

Recruitment end date

31/08/2018

Locations

Countries of recruitment

Finland

Trial participating centre

Music Therapy Clinic for Research and Training, Finnish Centre for Interdisciplinary Music Reserach, Department of Music, Art and Culture Studies
P.O. Box 35 (M), FI-40014 University of Jyväskylä
Jyväskylä
40014
Finland

Sponsor information

Organisation

University of Jyväskylä

Sponsor details

P.O. Box 35
Jyväskylä
40014
Finland

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Academy of Finland

Alternative name(s)

Suomen Akatemia, Finlands Akademi

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Finland

Results and Publications

Publication and dissemination plan

The main publication will be submitted to an international journal in the field of psychiatry. The publication will include the main results based on our primary and secondary outcome measures. We except to be able to submit this publication during the Spring 2020.

IPD sharing statement:
At this point make the data will not be made available for outsiders based on data repository. This is due to ethical details/restrictions. We will work for getting part of our data accessible but it may mean amendments to our ethical permission, which takes too much time and effort at this stage. So, data repository is not available but may be in future concerning certain parts of data.

Intention to publish date

31/08/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes