Cognitive Enhancement in Unipolar Depression With Yoga

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.

Study Overview

• Status: Recruiting
• Conditions: Unipolar Depression
• Intervention / Treatment: Behavioral: Adjuvant yoga intervention

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vishwajit L Nimgaonkar; Phone Number: 4127265164; Email: vishwajitnl@upmc.edu
• Study Contact Backup: Name: Triptish Bhatia; Phone Number: +919910107210; Email: trb16@pitt.edu

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560029
      • Recruiting
      • National Institute of Mental Health and Neuroscience (NIMHANS)
      • Contact: Daiveek G Pattanashetty, MD; Phone Number: +919482023658; Email: daiveek1991@gmail.com
      • Contact: Smita N Deshpande, MD; Phone Number: +919312654702; Email: smitadeshp@gmail.com
      • Principal Investigator: Daiveek G Pattanashetty, MD
      • Sub-Investigator: Triptish Bhatia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjuvant yoga intervention group; 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.	Behavioral: Adjuvant yoga intervention; 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.
No Intervention: Treatment as usual group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline,after six weeks yoga and after four weeks of completion of yoga

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustainability of cognitive inhibition	To compare the difference in cognitive inhibition weeks post adjuvant yoga intervention, as measured by the scores on Stroop test.	four weeks of completion of yoga
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.	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.	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.	four weeks of completion of yoga

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Fogarty International Center of the National Institute of Health; National Institute of Mental Health and Neuro Sciences, India
• Investigators: Principal Investigator: Vishwajit L Nimgaonkar, MD, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Yoga; Unipolar depression
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: STUDY22090102; 5D43TW009114-10 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: One year after publication of this study.
• IPD Sharing Access Criteria: For individual participant data, meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No