To examine whether adding yoga-based therapy (YBT) to treatment as usual (TAU) for young women with MDD leads to (1) greater reductions in symptoms and (2) greater cost-effectiveness in that the economic benefits of adding YBT to TAU outweigh the…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary hypotheses are that compared both to TAU, YBT (+TAU) will show greater
long-term (H1.1) reductions in clinician-administered (Hamilton Depression and
Anxiety Rating Scales) and self-report (Depression Anxiety Stress Scales)
measures of depression and (H1.2) cost-effectiveness.
Secondary outcome
Secondary hypotheses are that YBT effects are partially mediated by cognitive
mechanisms, including (H2.1) brooding and (H2.2) self-criticism. Exploratory
analyses will examine potential moderators of YBT.
Background summary
Major Depressive Disorder (MDD) is widespread, as nearly one in five Dutch will
experience the disorder within their lifetime. In addition to individual
suffering, MDD creates great economic costs in the Netherlands and is a leading
contributor to the national disease burden. Although first-step interventions
can be helpful, many individuals with MDD do not seek treatment and current
interventions often fail to prevent the development of chronic, relapsing MDD.
There is thus a pressing need to develop and test new interventions for
depression. This need is particularly urgent in young adult women, as this
population is especially vulnerable to developing MDD. Yoga-based interventions
represent an innovative approach with great potential for treating depression.
The rationale of using yoga as a MDD intervention in young women includes
initial findings that yoga reduces depressive affect and yoga*s appeal in this
population. Although the initial findings are promising, previous research has
a number of methodological limitations such as insufficient statistical power,
inadequate control groups, and short follow-up periods. The proposed project is
designed to use rigorous methods to examine yoga as a treatment for acute
depression and as means of preventing the transition to a chronic, relapsing
disorder in a sample of young women.
Study objective
To examine whether adding yoga-based therapy (YBT) to treatment as usual (TAU)
for young women with MDD leads to (1) greater reductions in symptoms and (2)
greater cost-effectiveness in that the economic benefits of adding YBT to TAU
outweigh the costs.
Study design
The study will consist of a randomized controlled trial comparing YBT+TAU with
TAU. Assessments are completed at pre- and post-intervention (or equivalent
time period in TAU), and at 6- and 12-month follow-up.
Intervention
The intervention will consist of manualized YBT administered in 9 weekly
90-minute group sessions with home practice +TAU. TAU will consist of
interventions recommended by the Dutch guidelines for depression, including
psychotherapy, pharmacotherapy, psychosocial support by psychiatric nurses, or
some combination of these.
Study burden and risks
The burden for patients consists of completing questionnaires and computer
tasks at four points in time (time costs per assessment is 100, 90, 60 and 60
minutes) and includes a structured clinical interview (15 minutes). The benefit
for patients in the active treatment condition consists of receiving a yoga
training in which techniques are used that have proven to be effective in
treatment of mood disorders. Patients will receive nine 90-minute treatment
sessions. The patients will also be asked to engage in homework exercises
during the course of treatment (about 30 minutes per day, 6 days a week). To
our knowledge, there are no negative effects of this treatment. We consider the
risks of this study to be low, as patients are primarily asked to invest time
and effort.
Hereweg 80
Groningen 9725 AG
NL
Hereweg 80
Groningen 9725 AG
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Primary diagnosis of a major depressive disorder.
• Age >= 18 and <= 34.
• Being able to read, write, and speak Dutch.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Current diagnoses of bipolar disorder and substance dependence.
• Current psychotic symptoms.
• Active suicidality.
• Unwilling or inability to attend to 9 weekly sessions of yoga.
• Regular yoga practice (on average over the past 6 months, 30 or more minutes per week).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL59324.042.16 |
OMON | NL-OMON22129 |