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Psychiatry suriya-dissertation protocol-8.11.16
1. THE EFFECT OF ADJUNCTIVE YOGA THERAPY IN
DEPRESSIVE DISORDERS: A RANDOMISED STUDY
Investigator Dr. Suriyakumar T
1st year PG resident, Department of Psychiatry
Guide Dr. Eswaran S
Professor and Head, Department of Psychiatry
Co-guide 1 Dr. Ananda Balayogi Bhavanani
Deputy Director, Center for yoga Therapy Education and
Research(CYTER)
Co-guide 2 Dr. Sukanto Sarkar
Associate Professor, Department of Psychiatry
Co-guide 3 Dr. Sivaprakash B
Professor, Department of Psychiatry
D E PA RT M E N T S I N V O LV E D : Department of Psychiatry, MGMCRI
Centre for Yoga Therapy Education and Research(CYTER), SBV
2. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
• Depression: Major personal/economic impact.
• Disadvantages of antidepressants.
• Thus, depression is a common reason for the use of
complementary therapies.
• Yoga has shown some beneficial effects in
depression.
• Dearth of Indian research in this context.
• Yoga therapy (MT): Implementation of yoga therapy
by a qualified yoga therapist.
Need for the study
2
Background
3. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
To study the effect of adjunctive yoga therapy on
the outcome of depressive disorders.
3
Aim
4. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
1. To test the hypothesis that the addition of yoga
therapy to standard care influences the outcome of
depressive disorders.
2. To study the correlation between socio demographic &
clinical variables and the influence of adjunctive Yoga
therapy on the outcome of depressive disorders.
3. To study the relationship between belief about yoga &
the influence of adjunctive yoga therapy on the
outcome of depressive disorders.
4
Objectives
5. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
• Randomised intervention study.
• Data collection over a period of one year.
• Sample size 40 patients in each group as determined
by statistician and based on our departmental census
data.
Type of study
5
Methods
6. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
• All adult consecutive patients, aged >= 19 yrs,
with a current depressive disorder (DSM-5) will
be considered for inclusion into the study,
irrespective of current medication status.
• Availability of informed consent.
Inclusion criteria
6
Methods
7. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
• Psychosis
• Patients requiring Electroconvulsive therapy
• Severe Cognitive impairment & Intellectual
disability
• Patients not willing for in-patient care.
Exclusion criteria
7
Methods
8. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
Groups (random allocation) & sample size
8
Methods
• Patients requiring in-patient care are
considered for inclusion, and if consented will
be divided into 2 intervention groups - A & B
based on randomization.
• A minimum sample size of 40 will be ensured
for each of the 2 groups, adding up to a total of
80 patients.
9. Diagrammatic representation of the methodology
All consecutive patients, >=19yrs, with a current depressive disorder
Exclusion criteria
Informed Consent & randomisation
Excluded
Group A (Patients receiving Antidepressants
+Standard care+ yoga therapy)
Group B (Patients receiving
Antidepressants +Standard care ONLY)
HADS/MADRS/CGI/BAYS (Day 1) HADS/MADRS/CGI (Day 1)
HADS/MADRS/CGI
Day 10)
HADS/MADRS/CGI
(Day 10)
HADS/MADRS(After 1 month) HADS/MADRS(After 1 month)
NO
YES
Data analysis
Supervised yoga session+
Standard Care
Standard Care
AntidepressantsHome based yoga
session+
Antidepressants
BRIEF PROCEDURE
10. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
Intervention with adjunct yoga for 1 month
10
Methods
Group
Treatment as usual
(AD + counselling)
Hospital-based, clinician-supervised yoga therapy
+ Home-based yoga (Total= 30 sessions)
A +
At least 10 supervised (in IP) +
remaining sessions (at Home)
B + -
11. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
• Social demographic variables: Age, gender,
marital status, socio-economic status, domicile.
• Clinical variables: Subtype of depression,
duration of current episode, severity of current
episode, number of episodes.
Tools, study parameters, outcome measures
11
Methods
12. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
Tools, study parameters, outcome measures
12
Methods
TOOL 0 10 d 30 d
Montgomery-Asberg Depression Rating Scale 12 + + +
Hospital Anxiety Depression Scale 13 + + +
Beliefs about yoga scale 14 +
Clinical Global Impression – S 15 + + +
Clinical Global Impression – C 15 + +
13. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
• Descriptive statistics will be used.
• t-test for continuous variables & chi-square test for
categorical variables.
• Regression analysis for prediction of socio
demographic variables, clinical variables on the
influence of yoga therapy in the outcome of
depressive disorders
• Analysis will be done using SPSS
Statistical analysis
13
Methods
14. EFFECT OF ADJUNCTIVE YOGA THERAPY ON THE OUTCOME OF DEPRESSION
Dr. Suriya kumar ● Department of Psychiatry ● MGMCRI ● Pondicherry 607402
• Written, informed consent will be obtained clearly
indicating that they may or may not receive Yoga
therapy. People who are randomized into the
control group, will be given Yoga therapy, if they
desire, at the end of the 30 day period.
• All patients will receive standard care, irrespective
of the group and even if they opt out of the study.
14
Ethical issues