Unipolar DepressionNCT06472492
Cognitive Enhancement in Unipolar Depression With Yoga
A study testing Adjuvant yoga intervention in people with Unipolar Depression, run by University of Pittsburgh at 1 site in India.
Trial summary
It is evident from recent studies that cognitive deficits persist even after remission of depressive episode. Hence, in this study, the investigators would like to see whether specific Yoga practice will help in enhancing cognitive abilities in this population. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Adjuvant yoga intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 17 May 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age more than 18years and less than 60 years
- H/o at least one depressive episode which is under remission and at the time of examination and throughout the study duration,
- Informed Consent
Who cannot join
- Comorbid Psychosis, OCD, Bipolar disorder
- Comorbid ADHD, IDD
- Comorbid substance dependence (except tobacco)
- Comorbid major or minor cognitive impairment,
- Bi temporal ECT within 6 months
- Past yoga practice - regularly for 1 month within 3 months Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
National Institute of Mental Health and Neuroscience (NIMHANS)
Bengaluru, Karnataka, 560029
Daiveek G Pattanashetty, MD, +919482023658, daiveek1991@gmail.com
Smita N Deshpande, MD, +919312654702, smitadeshp@gmail.com
About this study
Official title: A Randomized Control Trial Involving Yoga Intervention for Cognitive Enhancement in Persons With Remitted Unipolar Depression
It is evident from recent studies that cognitive deficits persist even after remission of depressive episode. Hence, in this study, the investigators would like to see whether specific Yoga practice will help in enhancing cognitive abilities in this population.
Read the detailed description
Depression is a common mental health condition affecting many people around the world. It affects the person's mood, thinking (cognition), behavior and also physical health causing difficulty in performing duties in efficient way. Most of these problems can be treated by medicines and/or talk therapies. But the research shows that even after the recovery from most of these problems, most individuals continue to have difficulties in capacity to think properly, they are specifically called as dysfunction in executive functions of our mind. The executive functions are a set of skills which make us possible to play with ideas, taking time to think before acting, meeting novel, unanticipated challenges, resisting temptations, staying focused., etc.
To overcome these problems currently there is no standard solution. However, the previous studies have shown that specific Yoga practices help in overcoming these challenges in general population. Hence it is planned of testing whether regular practice of a specific Yoga along with ongoing treatment for depression would benefit persons in enhancing their thinking capabilities.
Screening procedure:
The screening will be a verbal process where the patient will be verbally asked about the symptoms to check eligibility criteria of this study. If the patient is not eligible after completing this questionnaire, then the participation in this study will end.
(PS: Screening procedures for the study eligibility may involve the review and collection of information from patient's medical record.) This will be followed by obtaining written informed consent from the patient if the person considers participating in the study.
The eligible and consenting participants will be screened for severity of depression using a questionnaire.
After successful entry into the study, the patient will be asked about the demographic details including medical, treatment history.
Later, base line assessments to assess the cognitive functions will be done by the SRF. They are pen and paper tests. Total 3 types of tests will be done which may take around 25 to 30 minutes..
- Each person will be randomly assigned (like flip of a coin) to either yoga group or treatment as usual group.
- . If the participant is in the yoga group, he/she will be asked to attend Specific Yoga Practices of duration around 1 Hour every day under a trained therapist for about 6 days in a week for 6 weeks. The cognitive assessments are repeated at the end of 6 weeks and also after a gap of 4 weeks of no yoga practice.
- The treatment as usual group will undergo regular treatment as usual..
- The assessments will be repeated after 6 weeks of yoga and after 4 weeks of discontinuation for both participants of yoga group and treatment as usual group.
Total duration - 10 weeks (including 6 weeks of active participation) After the final assessment the TAU participant will be given an option for joining yoga sessions provided in the yoga center at NIMHANS. But this will not be the part of this study Assessment sessions - 3 and Time interval for assessment - Baseline - 6 weeks - 4 weeks
- Conditions
- Unipolar Depression
- Being tested
- Adjuvant yoga intervention
- Keywords
- Unipolar depression, Yoga
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant yoga interventionBehavioural
The yoga will include following asanas under the supervision of a yoga therapist. This will include Griva Shithilikarana, Skandha Sanchalana , Kati Sanchalana, Jaanu Sanchalana, Pada Sanchalana, Tadasana, Kati Sakti Vikasaka, Konasana,Marjari Asana, Vakrasana, Pascimottanasana, Matsyasana, Bhujangasana, Ardha Shalabhasana, Viparitakarani, Pavanamuktasana, Setubhandasana, Shavasana, Kapalabhati, Surya-anuloma pranayama, Chandraanuloma pranayama, Bhastrika, Bhramari Pranayama, Nadanusandhana.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant yoga intervention group | Experimental | The yoga group will attend the yoga under the guidance of a therapist for 6 weeks (6 days a week).yoga group, the participant needs to attend Specific Yoga Practices of duration around 1 Hour every day under a trained therapist for about 6 days in a week for 6 weeks, along with your ongoing medications (online/offline).. It includes warme up exercises and asanas. Receives: Behavioral: Adjuvant yoga intervention |
| Treatment as usual group | No intervention | The treatment-as-usual group will continue with usual treatment.the treatment as usual group will continue the ongoing medications for next 6 weeks. But participants will be coming for cognitive assessments at the end of 6 weeks and 4 weeks later. After the final assessment they will be given an option for joining yoga sessions provided in the yoga center at NIMHANS. But this will not be the part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory (Digit Span)
To study the change in working memory in intervention group as measured by digit span test in comparison to treatment as usual. The range of the scale is 0 to 28 points and higher is better memory.
Measured: Baseline, after six weeks yoga and after four weeks of completion of yoga
Attention and processing speed(Trail A and B)
To study the change in attention and processing speed in intervention group as measured by Trail A and B test in comparison to treatment as usual. The scoring is based on time taken to complete the test. Less the time taken, better the attention and processing speed.
Measured: Baseline, after six weeks yoga and after four weeks of completion of yoga
Cognitive flexibility
To study the change in cognitive flexibility in intervention group as measured by stroop test test in comparison to treatment as usual. Stroop test also measures time to complete the task and less the time, better the score is.
Measured: Baseline,after six weeks yoga and after four weeks of completion of yoga
Cognitive inhibition
To study the change in cognitive inhibition in intervention group as measured by stroop test test in comparison to treatment as usual.
Measured: Baseline,after six weeks yoga and after four weeks of completion of yoga
Secondary outcomes (4)
Sustainability of working memory
To compare the difference in the working memory 4 weeks post adjuvant yoga intervention, as measured by the scores on Digit span test.test in comparison to treatment as usual.The range of the scale is 0 to 28 points and higher is better memory.
Measured: four weeks of completion of yoga
Sustainability of attention and processing speed
To compare the difference in attention and processing speed 4 weeks post adjuvant yoga intervention, as measured by Trail Making A and B tests. The scoring is based on time taken to complete the task. Less the time taken, more is the attention and processing speed.
Measured: four weeks of completion of yoga
Sustainability of cognitive flexibility
To compare the difference incognitive flexibility 4 weeks post adjuvant yoga intervention, as measured by Stroop test. Stroop test also measures time to complete the task and less the time, better the cognitive flexibility is.
Measured: four weeks of completion of yoga
Sustainability of cognitive inhibition
To compare the difference in cognitive inhibition weeks post adjuvant yoga intervention, as measured by the scores on Stroop test.
Measured: four weeks of completion of yoga
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start17 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- The proposed study is a Randomized controlled trial. The eligible and consenting participants will be screened for the severity of depression using Hamilton Depression Rating Scale. Participants scoring \<8 will be considered for the study. They will be assessed for their level of cognitive functioning (Baseline) using digit span test (forward and backward), Trail making test Part A and B, Stroop color word test. The baseline scores will be noted Each person will be randomly assigned to either yoga group or treatment-as-usual group. The yoga group will attend the yoga under the guidance of a therapist for 6 weeks (6 days a week). The treatment-as-usual group will continue with usual treatment. The assessments will be repeated after 6 weeks of supervised yoga and after 4 weeks of discontinuation of supervised yoga for both participants of yoga group and treatment-as-usual group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, National Institute of Mental Health and Neuro Sciences, India
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit L Nimgaonkar, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472492
- Sponsor's protocol ID
- STUDY22090102
- Other IDs
- 5D43TW009114-10
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Involving Yoga Intervention for Cognitive Enhancement in Persons With Remitted Unipolar Depression
- ClinicalTrials.gov ID
- NCT06472492
- Acronym / sponsor ID
- STUDY22090102
- Conditions
- Unipolar Depression
- Keywords
- Unipolar depression, Yoga
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, National Institute of Mental Health and Neuro Sciences, India
- Study start
- 17 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Jun 2024 (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.
It is evident from recent studies that cognitive deficits persist even after remission of depressive episode. Hence, in this study, the investigators would like to see whether specific Yoga practice will help in enhancing cognitive abilities in this population.
Detailed description
Depression is a common mental health condition affecting many people around the world. It affects the person's mood, thinking (cognition), behavior and also physical health causing difficulty in performing duties in efficient way. Most of these problems can be treated by medicines and/or talk therapies. But the research shows that even after the recovery from most of these problems, most individuals continue to have difficulties in capacity to think properly, they are specifically called as dysfunction in executive functions of our mind. The executive functions are a set of skills which make us possible to play with ideas, taking time to think before acting, meeting novel, unanticipated challenges, resisting temptations, staying focused., etc.
To overcome these problems currently there is no standard solution. However, the previous studies have shown that specific Yoga practices help in overcoming these challenges in general population. Hence it is planned of testing whether regular practice of a specific Yoga along with ongoing treatment for depression would benefit persons in enhancing their thinking capabilities.
Screening procedure:
The screening will be a verbal process where the patient will be verbally asked about the symptoms to check eligibility criteria of this study. If the patient is not eligible after completing this questionnaire, then the participation in this study will end.
(PS: Screening procedures for the study eligibility may involve the review and collection of information from patient's medical record.) This will be followed by obtaining written informed consent from the patient if the person considers participating in the study.
The eligible and consenting participants will be screened for severity of depression using a questionnaire.
After successful entry into the study, the patient will be asked about the demographic details including medical, treatment history.
Later, base line assessments to assess the cognitive functions will be done by the SRF. They are pen and paper tests. Total 3 types of tests will be done which may take around 25 to 30 minutes..
- Each person will be randomly assigned (like flip of a coin) to either yoga group or treatment as usual group.
- . If the participant is in the yoga group, he/she will be asked to attend Specific Yoga Practices of duration around 1 Hour every day under a trained therapist for about 6 days in a week for 6 weeks. The cognitive assessments are repeated at the end of 6 weeks and also after a gap of 4 weeks of no yoga practice.
- The treatment as usual group will undergo regular treatment as usual..
- The assessments will be repeated after 6 weeks of yoga and after 4 weeks of discontinuation for both participants of yoga group and treatment as usual group.
Total duration - 10 weeks (including 6 weeks of active participation) After the final assessment the TAU participant will be given an option for joining yoga sessions provided in the yoga center at NIMHANS. But this will not be the part of this study Assessment sessions - 3 and Time interval for assessment - Baseline - 6 weeks - 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed study is a Randomized controlled trial. The eligible and consenting participants will be screened for the severity of depression using Hamilton Depression Rating Scale. Participants scoring <8 will be considered for the study. They will be assessed for their level of cognitive functioning (Baseline) using digit span test (forward and backward), Trail making test Part A and B, Stroop color word test. The baseline scores will be noted Each person will be randomly assigned to either yoga group or treatment-as-usual group. The yoga group will attend the yoga under the guidance of a therapist for 6 weeks (6 days a week). The treatment-as-usual group will continue with usual treatment. The assessments will be repeated after 6 weeks of supervised yoga and after 4 weeks of discontinuation of supervised yoga for both participants of yoga group and treatment-as-usual group.
| Arm | Type | Receives |
|---|---|---|
| Adjuvant yoga intervention group | Experimental | Behavioral: Adjuvant yoga interventionThe yoga group will attend the yoga under the guidance of a therapist for 6 weeks (6 days a week).yoga group, the participant needs to attend Specific Yoga Practices of duration around 1 Hour every day under a trained therapist for about 6 days in a week for 6 weeks, along with your ongoing medications (online/offline).. It includes warme up exercises and asanas. |
| Treatment as usual group | No intervention | –The treatment-as-usual group will continue with usual treatment.the treatment as usual group will continue the ongoing medications for next 6 weeks. But participants will be coming for cognitive assessments at the end of 6 weeks and 4 weeks later. After the final assessment they will be given an option for joining yoga sessions provided in the yoga center at NIMHANS. But this will not be the part of this study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age more than 18years and less than 60 years
- H/o at least one depressive episode which is under remission and at the time of examination and throughout the study duration,
- Informed Consent
Key exclusion criteria (6 listed)
- Comorbid Psychosis, OCD, Bipolar disorder
- Comorbid ADHD, IDD
- Comorbid substance dependence (except tobacco)
- Comorbid major or minor cognitive impairment,
- Bi temporal ECT within 6 months
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 |
|---|---|---|
| Adjuvant yoga interventionThe yoga will include following asanas under the supervision of a yoga therapist. This will include Griva Shithilikarana, Skandha Sanchalana , Kati Sanchalana, Jaanu Sanchalana, Pada Sanchalana, Tadasana, Kati Sakti Vikasaka, Konasana,Marjari Asana, Vakrasana, Pascimottanasana, Matsyasana, Bhujangasana, Ardha Shalabhasana, Viparitakarani, Pavanamuktasana, Setubhandasana, Shavasana, Kapalabhati, Surya-anuloma pranayama, Chandraanuloma pranayama, Bhastrika, Bhramari Pranayama, Nadanusandhana. | Behavioural | Adjuvant yoga intervention group |
Primary outcome
Working memory (Digit Span)
Time frame: Baseline, after six weeks yoga and after four weeks of completion of yoga
To study the change in working memory in intervention group as measured by digit span test in comparison to treatment as usual. The range of the scale is 0 to 28 points and higher is better memory.
Attention and processing speed(Trail A and B)
Time frame: Baseline, after six weeks yoga and after four weeks of completion of yoga
To study the change in attention and processing speed in intervention group as measured by Trail A and B test in comparison to treatment as usual. The scoring is based on time taken to complete the test. Less the time taken, better the attention and processing speed.
Cognitive flexibility
Time frame: Baseline,after six weeks yoga and after four weeks of completion of yoga
To study the change in cognitive flexibility in intervention group as measured by stroop test test in comparison to treatment as usual. Stroop test also measures time to complete the task and less the time, better the score is.
Cognitive inhibition
Time frame: Baseline,after six weeks yoga and after four weeks of completion of yoga
To study the change in cognitive inhibition in intervention group as measured by stroop test test in comparison to treatment as usual.
4 secondary outcomes
Sustainability of working memory
Time frame: four weeks of completion of yoga
Sustainability of attention and processing speed
Time frame: four weeks of completion of yoga
Sustainability of cognitive flexibility
Time frame: four weeks of completion of yoga
Sustainability of cognitive inhibition
Time frame: four weeks of completion of yoga
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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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.
Vishwajit L Nimgaonkar, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjuvant yoga intervention in people with Unipolar Depression, run by University of Pittsburgh at 1 site in India.
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 6 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vishwajit L Nimgaonkar (4127265164, vishwajitnl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory (Digit Span) (time frame: Baseline, after six weeks yoga and after four weeks of completion of yoga). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.