Major Depressive DisorderNCT03388177
Yoga for Young Women With Depression
A study testing Yoga-based therapy and Treatment as usual in people with Major Depressive Disorder, run by University of Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Yoga-based therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Dec 2016to 16 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of a major depressive disorder.
- Age ≥ 18 and ≤ 34.
- Ability to fluently read, write, and speak Dutch.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Lentis Psychiatric Institute
Groningen, 9725AG
Nina Vollbehr, MSc, 0031505223135, n.vollbehr@lentis.nl
Rogier Hoenders, PhD, 0031505223135, hjr.hoenders@lentis.nl
About this study
Official title: Yoga-based Therapy for Young Women With Depression: a Randomized Controlled Trial
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.
Read the detailed description
BACKGROUND 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, 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.
OBJECTIVE The overall objective of this project is to examine the potential benefits of adding a yoga-based intervention (YBI) to treatment as usual (TAU) for young women with major depressive disorder (MDD). This objective will be examined with the following four specific aims: (1) to examine whether adding YBI to TAU leads to greater and sustained reductions in symptoms, and (2) better general functioning in young women with MDD at post-intervention and at 6- and 12-month follow-up, (3) to examine the cost-effectiveness of adding YBI to TAU and, (4) these effects are mediated by change in rumination, self-criticism, intolerance of uncertainty, interoceptive awareness, and dispositional mindfulness.
HYPOTHESES The hypotheses (H) are that compared to TAU, YBI+TAU will lead to: (H1) greater reductions in depressive symptoms, assessed with clinician-administered and self-report measures, and (H2) better general functioning, defined as (H2.1) daily functioning, (H2.2) quality of life and physical health, and (H2.3) positive psychological functioning. The investigators further hypothesize that (H4) compared both to TAU, YBT (+TAU) will show greater cost-effectiveness, and that these YBI effects on symptoms of depression are partially mediated by (H4.1) reduced self-report and implicit rumination about the causes and consequences of negative events and moods, (H4.2) reduced self-report and implicit self-criticism/increased self-compassion after perceived failures, (H4.3) decreased intolerance of uncertainty, (H4.4) increased body awareness/interoceptive awareness, and (H4.5) increased mindfulness.
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.
STUDY POPULATION Young adult women (age 18-34 years) with a primary diagnosis of MDD.
INTERVENTION The intervention will consist of manualized YBT administered in 9 weekly 90-minute group sessions with home practice +TAU.
USUAL CARE 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.
OUTCOME MEASURES Primary outcome measures will consist of clinician-administered and self-report measures of depression symptoms and the presence/absence of a diagnoses of Major Depressive Disorder. Secondary outcome measures are daily functioning, quality of life and physical health, and positive psychological functioning. Potential mediators are self-report measures of perseverative thinking, self-criticism, intolerance of uncertainty, interoceptive awareness and dispositional mindfulness, and implicit measures of perseverative thinking and self-criticism. Quality-Adjusted Life Years will be used as primary outcome measure in the economic analysis.
SAMPLE SIZE/DATA ANALYSIS A sample of N=64/group will be recruited in order to have power of 80% (alpha=.05) to detect medium effect size differences between groups. Allowing attrition of 25%, 170 (85/group) patients will be recruited. Repeated-measures ANOVAs and Chi-square analyses will be conducted.
COST EFFECTIVENESS ANALYSIS An economic evaluation will be conducted alongside the clinical study to assess the potential cost-effectiveness of YBT compared to TAU from a societal perspective. A budget impact analysis (BIA) will be conducted to inform decision-makers about the potential financial consequences of the adoption and diffusion of YBT in the Dutch healthcare system.
- Conditions
- Major Depressive Disorder
- Being tested
- Yoga-based therapy, Treatment as usual
- Keywords
- Depression, Young adult women, Yoga
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-based therapyBehavioural
Treatment as usualOther
Also called Care as usual
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Yoga-based therapy; Other: 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
Secondary outcomes (15)
Structured clinical interview for DSM-IV
Clinician administered. Structured clinical interview for DSM-IV to assess diagnosis of MDD; 5 out of 9 symptoms to have a diagnosis of MDD.
Measured: 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)
Self-report. Depression Anxiety Stress Scales: to assess symptoms of anxiety with total possible score of 0-21; higher values represent more anxiety
Measured: 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)
Self-report. Depression Anxiety Stress Scales: to assess symptoms of stress with total possible score of 0-21; higher values represent more stress
Measured: 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)
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.
Measured: 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)
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).
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
Change in Perseverative thinking Questionnaire (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month follow-up)
Self report. To assess repetitive negative thinking; total scores from 0-60; higher values represent more repetitive negative thinking.
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
Change in Exogenous cuing task (from baseline to 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.
Measured: Baseline and 10-15 weeks post baseline
Change in Self-Compassion Scales (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month 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).
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
Change in Implicit Association Test (of depression self-concept) (from baseline to 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'.
Measured: Baseline and 10-15 weeks post baseline
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)
Intolerance of Uncertainty Scale-short form: to assess intolerance of uncertainty; total scores from 12-60; higher values represent more intolerance of uncertainty.
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
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)
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
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
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)
Self-report (Awareness scale of the Scale of Body Connection)
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
Change in Work and Social Adjustment Scale (from baseline to 10-15 weeks post baseline, 6-month follow-up and 12-month 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.
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
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)
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.
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
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)
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.
Measured: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start16 Dec 2016
- Primary completion16 Dec 2018 (estimated)
- Study completion16 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Lentis Psychiatric Institute, ZonMw: The Netherlands Organisation for Health Research and Development, Triodos Foundation
- Responsible party
- Principal investigator, Brian Ostafin, University of Groningen
- Investigators
- Brian D. Ostafin, Principal investigator, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388177
- Sponsor's protocol ID
- 60-63600-98-127
- Status last verified
- Feb 2018
- First submitted
- 2 Nov 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vollbehr NK, Stant AD, Hoenders HJR, Bartels-Velthuis AA, Nauta MH, Castelein S, Schroevers MJ, de Jong PJ, Ostafin BD. Cost-effectiveness of a mindful yoga intervention added to treatment as usual for young women with major depressive disorder versus treatment as usual only: Cost-effectiveness of yoga for young women with depression. Psychiatry Res. 2024 Mar;333:115692. doi: 10.1016/j.psychres.2023.115692. Epub 2023 Dec 30.
PubMed 38309011Vollbehr 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.
PubMed 36701531
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga-based Therapy for Young Women With Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03388177
- Acronym / sponsor ID
- 60-63600-98-127
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Young adult women, Yoga
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Collaborators
- Lentis Psychiatric Institute, ZonMw: The Netherlands Organisation for Health Research and Development, Triodos Foundation
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 16 Dec 2018 (estimated)
- Study completion
- 16 Dec 2019 (estimated)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND 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, 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.
OBJECTIVE The overall objective of this project is to examine the potential benefits of adding a yoga-based intervention (YBI) to treatment as usual (TAU) for young women with major depressive disorder (MDD). This objective will be examined with the following four specific aims: (1) to examine whether adding YBI to TAU leads to greater and sustained reductions in symptoms, and (2) better general functioning in young women with MDD at post-intervention and at 6- and 12-month follow-up, (3) to examine the cost-effectiveness of adding YBI to TAU and, (4) these effects are mediated by change in rumination, self-criticism, intolerance of uncertainty, interoceptive awareness, and dispositional mindfulness.
HYPOTHESES The hypotheses (H) are that compared to TAU, YBI+TAU will lead to: (H1) greater reductions in depressive symptoms, assessed with clinician-administered and self-report measures, and (H2) better general functioning, defined as (H2.1) daily functioning, (H2.2) quality of life and physical health, and (H2.3) positive psychological functioning. The investigators further hypothesize that (H4) compared both to TAU, YBT (+TAU) will show greater cost-effectiveness, and that these YBI effects on symptoms of depression are partially mediated by (H4.1) reduced self-report and implicit rumination about the causes and consequences of negative events and moods, (H4.2) reduced self-report and implicit self-criticism/increased self-compassion after perceived failures, (H4.3) decreased intolerance of uncertainty, (H4.4) increased body awareness/interoceptive awareness, and (H4.5) increased mindfulness.
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.
STUDY POPULATION Young adult women (age 18-34 years) with a primary diagnosis of MDD.
INTERVENTION The intervention will consist of manualized YBT administered in 9 weekly 90-minute group sessions with home practice +TAU.
USUAL CARE 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.
OUTCOME MEASURES Primary outcome measures will consist of clinician-administered and self-report measures of depression symptoms and the presence/absence of a diagnoses of Major Depressive Disorder. Secondary outcome measures are daily functioning, quality of life and physical health, and positive psychological functioning. Potential mediators are self-report measures of perseverative thinking, self-criticism, intolerance of uncertainty, interoceptive awareness and dispositional mindfulness, and implicit measures of perseverative thinking and self-criticism. Quality-Adjusted Life Years will be used as primary outcome measure in the economic analysis.
SAMPLE SIZE/DATA ANALYSIS A sample of N=64/group will be recruited in order to have power of 80% (alpha=.05) to detect medium effect size differences between groups. Allowing attrition of 25%, 170 (85/group) patients will be recruited. Repeated-measures ANOVAs and Chi-square analyses will be conducted.
COST EFFECTIVENESS ANALYSIS An economic evaluation will be conducted alongside the clinical study to assess the potential cost-effectiveness of YBT compared to TAU from a societal perspective. A budget impact analysis (BIA) will be conducted to inform decision-makers about the potential financial consequences of the adoption and diffusion of YBT in the Dutch healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual + Yoga-based therapy | Experimental | Behavioral: Yoga-based therapy, Other: Treatment as usualThe 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. |
| Treatment as usual | Other | Other: Treatment as usualThe 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primary diagnosis of a major depressive disorder.
- Age ≥ 18 and ≤ 34.
- Ability to fluently read, write, and speak Dutch.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga-based therapy | Behavioural | Treatment as usual + Yoga-based therapy |
| Treatment as usualAlso: Care as usual | Other | Treatment as usual, Treatment as usual + Yoga-based therapy |
Primary outcome
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.
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
15 secondary outcomes
Structured clinical interview for DSM-IV
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 10-15 weeks post baseline, 6 and 12 months follow-up
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
Change in Exogenous cuing task (from baseline to 10-15 weeks post baseline)
Time frame: Baseline and 10-15 weeks post baseline
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 38309011Vollbehr NK, Stant AD, Hoenders HJR, Bartels-Velthuis AA, Nauta MH, Castelein S, Schroevers MJ, de Jong PJ, Ostafin BD. Cost-effectiveness of a mindful yoga intervention added to treatment as usual for young women with major depressive disorder versus treatment as usual only: Cost-effectiveness of yoga for young women with depression. Psychiatry Res. 2024 Mar;333:115692. doi: 10.1016/j.psychres.2023.115692. Epub 2023 Dec 30.
- Derived from this study: PubMed 36701531Vollbehr 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.
- Study website with informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian D. Ostafin principal investigator
University of Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga-based therapy and Treatment as usual in people with Major Depressive Disorder, run by University of Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian D. Ostafin, PhD (+31503634722, b.d.ostafin@rug.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388177, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.