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Yoga for Young Women With Depression

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ClinicalTrials.gov Identifier: NCT03388177
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
Lentis Psychiatric Institute
ZonMw: The Netherlands Organisation for Health Research and Development
Triodos Foundation
Information provided by (Responsible Party):
Brian Ostafin, University of Groningen

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Yoga-based therapy Other: Treatment as usual Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: The project uses a blinded rater to assess the primary outcome measure of symptoms of depression
Primary Purpose: Treatment
Official Title: Yoga-based Therapy for Young Women With Depression: a Randomized Controlled Trial
Actual Study Start Date : December 16, 2016
Estimated Primary Completion Date : December 16, 2018
Estimated Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment as usual + Yoga-based therapy
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 therapy
Other: Treatment as usual
Other Name: Care as usual

Treatment as usual
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
Other Name: Care as usual




Primary Outcome Measures :
  1. Change in Hamilton Depression Rating Scales (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months 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.

  2. 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) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months 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


Secondary Outcome Measures :
  1. Structured clinical interview for DSM-IV [ Time Frame: 12 months follow-up ]
    Clinician administered. Structured clinical interview for DSM-IV to assess diagnosis of MDD; 5 out of 9 symptoms to have a diagnosis of MDD.

  2. 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) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Self-report. Depression Anxiety Stress Scales: to assess symptoms of anxiety with total possible score of 0-21; higher values represent more anxiety

  3. 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) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Self-report. Depression Anxiety Stress Scales: to assess symptoms of stress with total possible score of 0-21; higher values represent more stress

  4. Healthcare use with healthcare consumption scale (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    The healthcare consumption scale is modified from the Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TiC-P). Societal costs will be calculated by combining results of the healthcare consumption scale with cost prices per unit of healthcare used.

  5. 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) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    The EQ-5d-5L is a preference-based health instrument aimed at 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each can be scored at 5 levels (ranging from no problems to extreme problems). In the context of cost-effectiveness studies, results of the EQ-5D-5L can be used to assess QALYs (when combined with information on life years).

  6. Change in Perseverative thinking Questionnaire (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Self report. To assess repetitive negative thinking; total scores from 0-60; higher values represent more repetitive negative thinking.

  7. Change in Exogenous cuing task (from baseline to 10-15 weeks post baseline) [ Time Frame: Baseline and 10-15 weeks post baseline ]
    This is a reaction time task that assesses attentional bias to depression-related stimuli. Larger difference score values (responses to depression-related vs. neutral stimuli) indicate greater automatic orienting to and greater difficulty in disengaging from depression-related stimuli.

  8. Change in Self-Compassion Scales (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Self report. Self-Compassion Scales used to assess self-compassion; total scores from 24-168, 6 subscales from 4-28; higher values represent more self-compassion; subscales are averaged as well as the total score (so scores range from 1-7).

  9. Change in Implicit Association Test (of depression self-concept) (from baseline to 10-15 weeks post baseline) [ Time Frame: Baseline and 10-15 weeks post baseline ]
    The Implicit Association Test is a reaction time task that will be used to assess the strength of associations between the categories of 'self' and 'depression' (relative to 'other' and 'elated'.

  10. Change in Intolerance of Uncertainty Scale-short form (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Intolerance of Uncertainty Scale-short form: to assess intolerance of uncertainty; total scores from 12-60; higher values represent more intolerance of uncertainty.

  11. Change in Five-Facet Mindfulness Questionnaire-short form (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Self report. Five-Facet Mindfulness Questionnaire-short form: to assess dispositional mindfulness; total scores from 24-120, 5 subscales from 4/5-20/24 (1 subscale consists of 4 items, the others of 5); higher scores represent more mindfulness; subscales are summed to combine for total score

  12. Change in Awareness scale of the Scale of Body Connection (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Self-report (Awareness scale of the Scale of Body Connection)

  13. Change in Work and Social Adjustment Scale (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Self-report. Work and Social Adjustment Scale: to assess work and social functioning; total scores from 0-40; higher values represent more problems in work and social functioning.

  14. Change in World Health Organization Quality of Life Questionnaire-brief (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    World Health Organization Quality of Life Questionnaire-brief: to assess quality of life; total scores from 25-125, 5 subscales from 2-10 (1 subscale contains 2 items), 7-35 (1 subscale contains 7 items), 6-30 (1 subscale contains 6 items), 3-15 (1 subscale contains 3 items) and 8-40 (1 subscale contains 2 items); higher values represent more quality of life and satisfaction, subscales are summed to combine for total score.

  15. Change in Scales of Psychological Well-being-short form (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up) [ Time Frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up ]
    Self report. Scales of Psychological Well-being-short form: to assess psychological wellbeing; total scores from 1-108, subscales from 1-54; higher values represent more psychological wellbeing; 2 subscales are analyzed separately and not combined.



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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388177


Contacts
Contact: Brian D. Ostafin, PhD +31503634722 b.d.ostafin@rug.nl
Contact: Nina K. Vollbehr, MS +31505223135 n.vollbehr@lentis.nl

Locations
Netherlands
Lentis Psychiatric Institute Recruiting
Groningen, Netherlands, 9725AG
Contact: Nina Vollbehr, MSc    0031505223135    n.vollbehr@lentis.nl   
Contact: Rogier Hoenders, PhD    0031505223135    hjr.hoenders@lentis.nl   
Sponsors and Collaborators
University of Groningen
Lentis Psychiatric Institute
ZonMw: The Netherlands Organisation for Health Research and Development
Triodos Foundation
Investigators
Principal Investigator: Brian D. Ostafin University of Groningen

Additional Information:
Responsible Party: Brian Ostafin, Associate Professor, University of Groningen
ClinicalTrials.gov Identifier: NCT03388177     History of Changes
Other Study ID Numbers: 60-63600-98-127
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Ostafin, University of Groningen:
Depression
Young adult women
Yoga

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders