NCT03388177

Brief Summary

The investigators examine whether adding yoga-based therapy (YBT) to treatment as usual (TAU) for young adult women (age 18-34 years) with a primary diagnosis of 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

November 2, 2017

Last Update Submit

February 2, 2018

Conditions

Major Depressive Disorder

Keywords

DepressionYoung adult womenYoga

Outcome Measures

Primary Outcomes (2)

  • Change in Hamilton Depression Rating Scales (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up)

    Clinician-administered. Hamilton Depression Rating Scales: to assess symptoms of depression; total scores from 0-52; higher value represent more symptoms of depression.

    Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up

  • Change in Depression scale of Depression Anxiety Stress Scales (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up)

    Self-report. Depression Anxiety Stress Scales: to assess symptoms of depression with total possible score of 0-21; higher values represent more depression

    Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up

Secondary Outcomes (15)

  • Structured clinical interview for DSM-IV

    12 months follow-up

  • Change in Anxiety scale of Depression Anxiety Stress Scales (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up)

    Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up

  • Change in Stress scale of Depression Anxiety Stress Scales (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up)

    Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up

  • Healthcare use with healthcare consumption scale (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up)

    Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up

  • Health-related quality of life with EQ-5D-5L (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up)

    Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up

  • +10 more secondary outcomes

Study Arms (2)

Treatment as usual + Yoga-based therapy

EXPERIMENTAL

The yoga-based therapy (YBT) group will receive YBT in addition to treatment-as-usual (TAU). YBT will be administered with a manualized protocol and delivered in a group format consisting of nine weekly sessions of 1,5 hours. Group sessions consist of hatha yoga practices of physical postures, breathing practices, and meditation. Each session has a different theme. The practices will primarily consist of yoga exercises (80%) and meditation (e.g., breathing practices) (20%). Between sessions, participants complete an online module with additional psychoeducation and a practice video to encourage home practice for 30-45 minutes a day. YBT will be delivered by a psychologist who is also a trained yoga teacher.

Behavioral: Yoga-based therapyOther: Treatment as usual

Treatment as usual

OTHER

The treatment as usual (TAU)-only condition will consist of interventions recommended by the Dutch guidelines for depression. These include the combination of pharmacotherapy (antidepressant medications) and psychotherapy (e.g., cognitive behavioral therapy \[CBT\], interpersonal psychotherapy). Lentis mental health clinicians will administer TAU. In order to improve ability to interpret study results, the investigators will record frequency, content (e.g., cognitive restructuring), format (group versus individual), and intensity of contact within TAU. Such quantification of TAU will allow us to address alternative explanations (e.g., contact time) in the case of positive results for YBT.

Other: Treatment as usual

Interventions

Yoga-based therapyBEHAVIORAL
Treatment as usual + Yoga-based therapy
Treatment as usualOTHER
Also known as: Care as usual
Treatment as usualTreatment as usual + Yoga-based therapy

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary diagnosis of a major depressive disorder.
  • Age ≥ 18 and ≤ 34.
  • Ability to fluently read, write, and speak Dutch.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lentis Psychiatric Institute

Groningen, 9725AG, Netherlands

RECRUITING

Related Publications (1)

  • Vollbehr NK, Hoenders HJR, Bartels-Velthuis AA, Nauta MH, Castelein S, Schroevers MJ, Stant AD, Albers CJ, de Jong PJ, Ostafin BD. Mindful yoga intervention as add-on to treatment as usual for young women with major depressive disorder: Results from a randomized controlled trial. J Consult Clin Psychol. 2022 Dec;90(12):925-941. doi: 10.1037/ccp0000777.

    PMID: 36701531DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Brian D. Ostafin

    University of Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian D. Ostafin, PhD

CONTACT

+31503634722b.d.ostafin@rug.nl

Nina K. Vollbehr, MS

CONTACT

+31505223135n.vollbehr@lentis.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The project uses a blinded rater to assess the primary outcome measure of symptoms of depression
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 2, 2017

First Posted

January 2, 2018

Study Start

December 16, 2016

Primary Completion

December 16, 2018

Study Completion

December 16, 2019

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

NL(1)