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Individual music therapy for depression: randomised controlled trial

  • Jaakko Erkkilä (a1), Marko Punkanen (a1), Jörg Fachner (a1), Esa Ala-Ruona (a1), Inga Pöntiö (a2), Mari Tervaniemi (a3), Mauno Vanhala (a4) and Christian Gold (a5)...
Abstract
Background

Music therapy has previously been found to be effective in the treatment of depression but the studies have been methodologically insufficient and lacking in clarity about the clinical model employed.

Aims

To determine the efficacy of music therapy added to standard care compared with standard care only in the treatment of depression among working-age people.

Method

Participants (n = 79) with an ICD–10 diagnosis of depression were randomised to receive individual music therapy plus standard care (20 bi-weekly sessions) or standard care only, and followed up at baseline, at 3 months (after intervention) and at 6 months. Clinical measures included depression, anxiety, general functioning, quality of life and alexithymia. Trial registration: ISRCTN84185937.

Results

Participants receiving music therapy plus standard care showed greater improvement than those receiving standard care only in depression symptoms (mean difference 4.65, 95% CI 0.59 to 8.70), anxiety symptoms (1.82, 95% CI 0.09 to 3.55) and general functioning (–4.58, 95% CI −8.93 to −0.24) at 3-month follow-up. The response rate was significantly higher for the music therapy plus standard care group than for the standard care only group (odds ratio 2.96, 95% CI 1.01 to 9.02).

Conclusions

Individual music therapy combined with standard care is effective for depression among working-age people with depression. The results of this study along with the previous research indicate that music therapy with its specific qualities is a valuable enhancement to established treatment practices.

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Copyright
Corresponding author
Christian Gold, GAMUT, Uni Health, Lars Hilles gt. 3, 5015 Bergen, Norway. Email: Christian.gold@uni.no
Footnotes
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See editorial, pp. 92–93, this issue.

The NEST (New and Emerging Science and Technology) programme of the European Commission (project BrainTuning FP6-2004-NEST-PATH-028570), and the programme for Centres of Excellence (CoEs) in research, Academy of Finland.

Declaration of interest

None.

Footnotes
References
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Individual music therapy for depression: randomised controlled trial

  • Jaakko Erkkilä (a1), Marko Punkanen (a1), Jörg Fachner (a1), Esa Ala-Ruona (a1), Inga Pöntiö (a2), Mari Tervaniemi (a3), Mauno Vanhala (a4) and Christian Gold (a5)...
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eLetters

Designing pragmatic and meaningful trials of psychosocial interventions. Reply to BJP eLetter by Sekhri and Jackson

Christian Gold, Principal Researcher
21 October 2011

Designingpragmatic and meaningful trials ofpsychosocial interventionsReplyto BJP eLetter by Sekhri and JacksonChristianGold, Jaakko Erkkila, Bruce WampoldChristianGold, PhD, GAMUT,Uni Health, Uni Research, Bergen, NorwayJaakkoErkkila,PhD, Finnish Centre of Excellence in Interdisciplinary MusicResearch, University of Jyvaskyla, FinlandBruceWampold, PhD, Departmentof Counseling Psychology, University ofWisconsin-Madison, USACorrespondence:Christian Gold, GAMUT, Uni Health, UniResearch, Lars Hilles gt. 3, 5015 Bergen, Norway. Phone +47-97501757.Email: christian.gold@uni.noDearDr. Sekhri and Dr. Jackson:Placebosin psychotherapy research are fundamentally different than placebosin pharmacological research, as discussed in depth by Wampold(Chapter 5).1First, it is not possible to blind therapist administering the shamtreatment - this is, the therapists in this arm of the trial knowthey are providing the patients a treatment that is intentionallydesigned not tobe therapeutic. Moreover, the therapists typically are also providingthe active treatment and have an allegiance to the active treatment. Comparisons reveal that legitimate psychotherapy treatments aresuperior to so-called psychotherapy placebos and reveal little aboutthe efficacy of the treatment. Second, a psychotherapy placebo isnot indistinguishable from the active treatment - one cannot removethe active ingredients from a treatment to yield anything credible tothe patient, as the placebo will have no cogent explanation ortreatment actions that patients expect in a treatment. Either aplacebo therapy is credible, in which case it is not a placebotherapy because it includes important active ingredients; or it isnot credible, in which case it does not serve the purpose of aplacebo. The question is therefore not whether a placebo therapy ispossibleto construct (it certainly is), but whether it can be constructed ina meaningfulway (it can't). It is a simple matter to design a treatment that willbe found to be superior to a psychotherapy placebo; more difficult isto design a treatment that will be superior to treatments intended tobe therapeutic. Thereis another reason why we chose not to use a placebo therapy in ourstudy.2We were interested in a comparison that is important for patients,and that can help patients to choose between options of care. Inother words, we aimed to construct a pragmatic trial.3Pragmatic trials are characterised by a closeness to usual practiceon all levels, including comparison treatments. In an influentialpaper describing ten dimensions on which pragmatic trials differ fromexplanatory trials, standard care or head-to-head comparisons betweenactive treatments were described as characterising pragmatic trialsbecause these are relevant alternatives in usual practice.3In contrast, placebo therapies characterise explanatory trialsbecause these trials have different aims.3Itis correct that our study did not show (nor did it aim to show) whichof the ingredients of music therapy were responsible for its effect.As discussed in our paper,2it could be the music, the therapeutic relationship, or a combinationof both. We believe it is most likely some combination, and suggest avariety of research strategies - from qualitative throughmixed-methods to neuroscientific - to find out more about thesemechanisms.2,4,5Indeedno psychotherapy has shown that the specific ingredients areresponsible for the benefits, and the use of psychotherapy placebosdoes not establish specificity in psychotherapy.1In line with pragmatic trials andpsychotherapy research, our trial tested a hypothesis that isimportant for patients, using a method that is meaningful andconsistent with theory. Future pragmatic trials in the area shouldconsider head-to-head comparisons of bona fide therapies,1not placebo therapies.References WampoldBE. The great psychotherapy debate: Models, methods and findings.Mahwah, NJ: Lawrence Erlbaum Associates; 2001. ErkkilaJ, Punkanen M, Fachner J, Ala-Ruona E, Pöntiö I,Tervaniemi M, et al. Individual music therapy for depression:Randomised controlled trial. Br J Psychiatry.2011;199(2):132-9. ThorpeKE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, etal. A pragmatic-explanatory continuum indicator summary (PRECIS): atool to help trial designers. J Clin Epidemiol.2009;62:464-75. ElseB, Wheeler B. Music therapy practice: relative perspectives inevidence-based reviews. Nord J Music Ther.2010;19(1):29-50. GoldC. Evaluating the quality of qualitative research (Editorial). NordJ Music Ther. 2010;19(1):1-2. ... More

Conflict of interest: None.

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Re:Refurbishment of randomized controlled blind design for psychological intervention

Christian Gold, Principal Researcher, Professor
29 September 2011

Replyto "Refurbishment of randomizedcontrolled blind design for psychological intervention" by Sen,Biswas, and SinhaJaakkoErkkila, Christian GoldJaakkoErkkila,PhD, Finnish Centre of Excellence in Interdisciplinary MusicResearch, University of Jyvaskyla, Finland; ChristianGold, PhD, GAMUT,Uni Health, Bergen, NorwayCorrespondence:Christian Gold, GAMUT, Uni Health, LarsHilles gt. 3, 5015 Bergen, Norway. Phone +47-97501757. Email:christian.gold@uni.no Itis interesting that a methodological debateis emerging around our randomised trial (RCT) of music therapy fordepression.1Sen and colleagues2could have used any RCT of a psychosocial intervention to discusstheir ideas of alternative designs. In relation to our specificstudy, they basically raise the following three points: 1.) That ourstudy was not double-blind; 2.) that patients may have had apreference for music therapy; and 3.) that the experimental group mayhave been followed up more carefully than the control group. We willrespond to these points in that order.1.)Studies of psychosocial interventions such as music therapy can neverbe double-blind. Both the therapist and the patient are aware of thetherapy they are providing or receiving, and active participation ofthe patient is necessary. Therefore, demanding a double-blind studyshows a limited understanding of the nature of these therapies. We donot always agree with the opinions of Seligman,3but he has put this point very aptly: "Wheneveryou hear someone demanding the double-blind study of psychotherapy,hold onto your wallet."Single-blind RCTs are the most rigorous evaluation method that ispossible in this field.2.)The advertisement through which potential participants were recruitedto our study did not mention music therapy. Therefore we believe thata strong preference for music therapy was unlikely in our sample,although we are not able to completely rule out the possibility.Extensions of RCTs such as Zelen's design4and partly randomised designs5are not new. They provide interesting options for evaluating manykinds of interventions, including music therapy; however, there arealso some good reasons why they are not used more frequently.Firstly, as Sen et al.2note, hybrid designs may be difficult to interpret. Secondly, thequestionable additional merits of these trials may not justify theirmuch higher costs. Our trial was the first of its kind, and a simplerandomised design therefore seemed most appropriate to us. For futuretrials of psychosocial interventions it may be relevant to explorethe potential use of hybrid designs.3.)In our study, the person who did the assessments, and who alsoscheduled the assessment interviews on her own, was blinded totreatment assignment, and only very few instances of broken blindingoccurred.1We can therefore exclude the possibility that the experimental groupmight have been followed up with greater care than the control group.Our conclusion remains that the differences in drop-out rates were aneffect of the treatment, not an artefact of the study design.Overall,Sen et al.2present interesting general thoughts for the evaluation ofpsychosocial interventions. Of the various suggestions made forimproving study designs, we believe that assessing treatmentpreference and incorporating it in either the design or the analysisis the most practicable one. Hybrid designs including both randomisedand non-randomised designs may be useful in certain circumstances,but because of their high costs and unclear interpretation we wouldnot recommend them for general use.References Erkkila J, Punkanen M,Fachner J, Ala-Ruona E, Pontio I, Tervaniemi M, et al. Individualmusic therapy for depression: Randomised controlled trial. BritishJournal of Psychiatry. 2011;199(2):132-9. Sen D, Biswas, PS, Sinha VK. Refurbishment ofrandomized controlled blind design for psychological intervention.2011. Seligman MEP. The effectiveness of psychotherapy:The Consumer Reports study. American Psychologist.1995;50(12):965-74. Zelen M. A new design for randomized clinical trials. N Engl J Med.1979;300(22):1242-5. MacLehose RR, Reeves BC, Harvey IM, Sheldon TA,Russell IT, Black AMS. A systematic review of comparisons of effectsizes from randomised and non-randomised studies. HealthTechnology Assessment. 2000;4(34). ... More

Conflict of interest: None declared

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Music therapy for depression: Does it really work?

Rajesh Sekhri, ST5, Old Age Psychiatry
14 September 2011

We read with interest the Erkkila J et. al. (1) article about music therapy for treatment of depression. Being old age psychiatrists we are always interested in non pharmacological approaches to treat depression asthere are high incidents of side effect with medications in this population group. (2)

The design of this RCT compares music therapy added to standard care compared with standard care only. Standard care is present in both the arms of this trial so as to balance the two groups but there is no placebointervention in control group. Because of imbalance in two arms of this trail, the central question of benefit of music therapy in depression remains unanswered. This lack of head to head comparison is a serious flawin this study. It is often perceived that a placebo arm is difficult to achieve with non-pharmacological interventions but is perfectly possible as we have previously demonstrated in our study (3)

It is inconclusive if the benefit derived from the treatment is related to treatment itself or from the Hawthorn effect (4). On average the participants assigned to music group received 18 music therapy sessions equivalent to 18 hours of extra intervention. This big differencein intervention is likely to induce the Hawthorn effect. The positive outcome in this group can be entirely attributed to the interest and care shown by the therapist, increased attention the group received and the engagement in structured activity rather than therapy itself. The study shows simply that any additional intervention is better than standard intervention – it does not demonstrate benefit from music therapy.

References1)Erkkilä J, Punkanen M, Fachner J, Ala-Ruona E, Pöntiö I, Tervaniemi M et al, Individual music therapy for depression: randomised controlled trial BJP August 2011 199:132-139; doi:10.1192/bjp.bp.110.085431 2)Hickie IB. Antidepressants in elderly people. BMJ 2011; 343:d46603)Jackson GA, Sterling R, Russell K & Templeton G. A multisensory programme: evaluating effects on agitation. Nursing and Residential Care, (2003) 5, 3:126-1294)Parson HM. What happened at Hawthorne? Science 1974;193:922–932.

Authors1)Rajesh Sekhri, ST5, Old Age Psychiatry, Leverndale Hospital Glasgow.2)Graham A Jackson, Consultant Psychiatrist, Leverndale Hospital Glasgow.

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Conflict of interest: None declared

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Refurbishment of randomized controlled blind design for psychological intervention

Devosri Sen, PhD Scholar (Clinical Psychology)
31 August 2011

The article on 'Individual music therapy for depression: randomised controlled trial' [1] and its methodology has been read with great interest. Although a better methodological quality has here been tried, we would like to share some important statistical pitfalls of the randomized design in the blinded trials of music therapy.

The randomized controlled trial (RCT) has been seen as the optimal design for estimating treatment efficacy in medical experiments. In a double-blind RCT, the placebo effect is equally distributed among treatment groups. In Erkkila'' et al.'s [1] trial music therapy gravitatedto involve both the patient and the therapist being aware of the treatmentthat the patient was receiving well before total data has been collected. Thus blinding has been menaced. Moreover, authors have not allowed for thepatients' treatment preferences. Patients who receive their preferred treatment may experience greater improvements in the outcome because of added motivation to follow the treatment protocol than patients who do notreceive their preferred treatment. In this instance, some alternatives to the RCT design could have been wielded. Firstly, randomized consent design(RCD) whereby patients are randomized to treatment groups prior to informed consent and subsequently informed consent is only sought for those patients who are allocated to the experimental treatment [2]. Here the sense of deprivation will be less in treatment as usual (TAU) group asthey are unaware of the opportunity they had to receive a new treatment. Secondly, partially randomized preference trial (PRPT) where patients without a treatment preference are randomized and patients with a treatment preference are allocated to the treatment of their choice. This design has recently been utilized in some studies with psychological interventions for depression. PRPTs have been recommended as they may improve the internal as well as external validity of clinical trials [3]. However, this may subject to the biases of an observational study and may not provide an unbiased measure of treatment effect. Thus in order to improve both internal and external validity further, Erkkila'' et al's [1]RCT could have included a measure of preferences and detailed characteristics of those who refuse to take part in the study due to random allocation of treatment. This would enable preference effects to bemeasured at the analysis stage and authors to estimate the external validity of the trial. Thirdly, the drop-out rate was higher in the control group (11 vs. 4) of the index study indicating probable more demanding and careful follow-up in the said group. Here Instrumental variable (IV) methods could have an advantage of adjustment for non-compliance and loss to follow up their study. Instrumental variable is associated with treatment choice (e.g., proximity to the music therapy clinic) but not with the outcome. Had the patients' preference been taken care of in this study at least some of the eligible patients would have refused to participate in the study, especially who live further away. Instrumental variable provides an estimate of treatment effect that is adjusted for some of the bias associated with the patient preference design [4]. Lastly, it is worthwhile to mention doubly randomized preference trial (DRPT) [5]. It is the most recently proposed methods of estimating causal effects and preference effects. Here patients are initially randomized to a randomization arm in which treatments are randomized or to a preference arm in which patients choose which treatmentthey receive.

Although we have discussed few alternatives to RCT, especially legitimate for studies where participants express a preference of their treatment or blinding is less pragmatic, these designs are not free of biases. Nevertheless, they can ameliorate the external and internal validity of trials.

References:

[1] Erkkila'' J, Punkanen M, Fachner J, Ala-Ruona E, Po''ntio'' I, Tervaniemi M, et al. Individual music therapy for depression: randomised controlled trial. Br J Psychiatry 2011; 199: 132-139.

[2] Zelen M. A new design for randomized clinical trials. N Engl J Med 1979; 300: 1242-1245.

[3] TenHave TR, Coyne J, Salzer M, Katz I. Research to improve the quality of care for depression: alternatives to the simple randomized clinical trial. Gen Hosp Psychiatry 2003; 25: 115-123.

[4] Greenland S. An introduction to instrumental variables for epidemiologists. Int J Epidemiol 2000; 29: 722-729.

[5] Long Q, Little R, Lin X. Causal inference in hybrid intervention trials involving treatment choice. J Am Stat Assoc 2008; 103: 474-484.

Authors:

Ms. Devosri Sen [1]*, Dr. Partha Sarathi Biswas [2] & Dr. (Prof.)V.K. Sinha [3]

Address:[1]. PhD Scholar, Department of Clinical Psychology, Central Institute of Psychiatry (CIP), Kanke, Ranchi, India;

[2]. Senior Resident, Department of Psychiatry, Ranchi Institute of Neuro-Psychiatry and Allied Sciences (RINPAS), Kanke, Ranchi, India;

[3]. Professor of Psychiatry, Central Institute of Psychiatry (CIP), Ranchi, India.

* Corresponding author

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Conflict of interest: None declared

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