Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472492
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
Cognitive Enhancement in Unipolar Depression With Yoga
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Randomized Control Trial Involving Yoga Intervention for Cognitive Enhancement in Persons With Remitted Unipolar Depression
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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 andor 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 patients 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 heshe 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
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 patients 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 heshe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009114 | NIH | None | None |