Receptive Music Therapy for the Treatment of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depressive symptoms are highly prevalent in the population. According to data from a Zurich
      longitudinal study, the lifetime incidence rate for severe depressive symptoms is 95%. Not
      all persons with depressive symptoms, however, need psychotherapeutic, psychiatric or
      pharmaceutical treatment. Many people specifically or unspecifically use music to influence
      their mood and clinical evidence demonstrates that active involvement in music supports an
      individual's treatment success during psychiatric therapy. The gray area of depressive
      symptoms that do not require medical treatment, but which contribute to a considerable
      disturbance of an individual's quality of life and ability to work, is the focus of the
      proposed study.

      The study investigates whether listening to specific music programs arranged to influence
      depressive symptoms for 30 minutes in the morning and 30 minutes in the evenings can result
      in improvement of an individual's symptoms, as compared to listening to no prescribed music
      or no music treatment at all. Of specific interest is the use of music in the evening, which
      may contribute to the achievement of restive sleep.

      The study's objective is to determine if the utilization of two specific music therapies to
      treat depressive symptoms, compared to a waiting list control intervention and an
      intervention listening to Mozart over a 5 week period, leads to an improvement of the
      depressive pathology among patients with moderate depressive disorders or patients with
      dysthymia. The study is designed as a simple blinded placebo-controlled study.
    

Detailed description: 
      Participants of this study will be recruited through radio and television programs on the
      topic of depressive symptomatology. The investigators assume that those who are undergoing a
      cycle of change between a stronger depressive mood and brightened spirits will be more likely
      to volunteer for study participation than those who are experiencing a period of stronger
      depressive mood. Consequently, we anticipate an improvement in depressive mood over the study
      period, even without therapy, for all participants as compared to study entry. To account for
      this effect, two control groups are included in the study design.

      Although the anticipated effect size attributable to the specific music is relatively small,
      depressive symptoms are highly prevalent in the population. Therefore, from a public health
      perspective, even a small effect on depressive symptomology could make an important
      contribution to this problem as interventions could be easily designed to be applied in broad
      circles of the population. Furthermore, the use of specific music may be found to play a role
      in the future primary prevention of depressive symptoms in the population.

      Sample size calculation based on on Cohen's d = 0.45. Total target for recruitment = 200
      participants.

      Potential participants will be targeted through advertisements on the radio and television.
      An internet website will be given during the radio or television advertisement. The website
      will only contain information about the study and an invitation to participate. Potential
      participants will be asked to apply by e-mail. The first 500 respondents will be sent a
      questionnaire in written form. Based on the estimated response rate and inclusion criteria,
      it is anticipated that 300 invitations for diagnostic interviews will be sent out in response
      to the received, completed questionnaires after the data has been imported and analyzed. From
      these 300 invitations, it is estimated that 200 individuals will agree to participation and
      will be further assessed as meeting the inclusion criteria. These 200 participants will be
      randomized to the intervention groups (n =100) and both control groups (n = 50 each).

      Once enrolled in the study, participants will complete an advanced psychometric
      classification through the use of:

        -  BDI Beck Depression Inventory (Version II),

        -  HADS-D Hospital Anxiety and Depression Scale

        -  SCL-90-R Symptom-Checklist by L.R. Derogatis

        -  STAXI State-Trait Anger Expression Inventory

        -  STAI-G X1 abd X2 State-Trait Anxiety Inventory

        -  TAS-20 Toronto-Alexithymia-Scale

        -  PSQI Pittsburgh Sleep Quality Index

        -  ME Morningness/Eveningness Questionnaire (Horne and Ostberg)

        -  Physiological measurements: heart rate variability measurements
    

Intervention name(s): Purpose designed music and sound listening program; Sham music for depression
Intervention type(s): Other; Other
Intervention description(s): Listening to one of two different specific music programs (Group A and B), which is composed for the treatment of depressive symptoms. The music is listened to during a period of 30 minutes in the morning and 30 minutes in the evening over 5 - 15 weeks.; Listening 30 min in the morning and 30 min in the evening to selection of Mozart compositions over 5 weeks.
Other intervention name(s): Receptive Sound and Music; Mozart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: depression; music; sound; randomized controlled trial