Меню
Идёт набор NCT06472492

Cognitive Enhancement in Unipolar Depression With Yoga

Без фазы С лечением Unipolar Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Adjuvant yoga intervention.
Кому может быть актуально
Состояния в реестре: Unipolar Depression. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Randomized Control Trial Involving Yoga Intervention for Cognitive Enhancement in Persons With Remitted Unipolar Depression

Обзор

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.

Подробное описание

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

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Working memory (Digit Span) [Срок оценки: Baseline, after six weeks yoga and after four weeks of completion of yoga]
  • Attention and processing speed(Trail A and B) [Срок оценки: Baseline, after six weeks yoga and after four weeks of completion of yoga]
  • Cognitive flexibility [Срок оценки: Baseline,after six weeks yoga and after four weeks of completion of yoga]
  • Cognitive inhibition [Срок оценки: Baseline,after six weeks yoga and after four weeks of completion of yoga]
Вторичные конечные точки (4)
  • Sustainability of working memory [Срок оценки: four weeks of completion of yoga]
  • Sustainability of attention and processing speed [Срок оценки: four weeks of completion of yoga]
  • Sustainability of cognitive flexibility [Срок оценки: four weeks of completion of yoga]
  • Sustainability of cognitive inhibition [Срок оценки: four weeks of completion of yoga]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Индия · 1 центр
  • National Institute of Mental Health and Neuroscience (NIMHANS) — Bengaluru

Идентификаторы

NCT: NCT06472492 · STUDY22090102 · 5D43TW009114-10

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗