Cognitive Enhancement in Unipolar Depression With Yoga

NCT ID: NCT06472492

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2025-12-31

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.

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

Keywords

Unipolar depression; Yoga

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Adjuvant yoga intervention

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Vishwajit Nimgaonkar, MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vishwajit L Nimgaonkar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

National Institute of Mental Health and Neuroscience (NIMHANS)

Bengaluru, Karnataka, India

Site Status: RECRUITING

Countries

India

Central Contacts

Vishwajit L Nimgaonkar

Role: CONTACT

Phone: 4127265164

Email: vishwajitnl@upmc.edu

Triptish Bhatia

Role: CONTACT

Phone: +919910107210

Email: trb16@pitt.edu

Facility Contacts

Daiveek G Pattanashetty, MD

Role: primary

Smita N Deshpande, MD

Role: backup

Other Identifiers

5D43TW009114-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY22090102

Identifier Type: -

Identifier Source: org_study_id