Cognitive Enhancement in Unipolar Depression With Yoga

NCT06472492 | Recruiting

• 2 other identifiers: STUDY220901025D43TW009114-10
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unipolar Depression

Keywords

Unipolar depression; Yoga

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Sustainability of working memory

  four weeks of completion of yoga

• Sustainability of attention and processing speed

  four weeks of completion of yoga

• Sustainability of cognitive flexibility

  four weeks of completion of yoga

• Sustainability of cognitive inhibition

  four weeks of completion of yoga

Study Arms (2)

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.

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.

Interventions

Adjuvant yoga intervention BEHAVIORAL

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.

Adjuvant yoga intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator
• National Institute of Mental Health and Neuro Sciences, India: collaborator

Study Sites (1)

National Institute of Mental Health and Neuroscience (NIMHANS)

Bengaluru, Karnataka, 560029, India

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Vishwajit L Nimgaonkar, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishwajit L Nimgaonkar

CONTACT

4127265164; vishwajitnl@upmc.edu

Triptish Bhatia

CONTACT

+919910107210; trb16@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of this study.
• Access Criteria: For individual participant data, meta-analysis.

Locations

IN (1)