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CTRI Number  CTRI/2020/05/025007 [Registered on: 04/05/2020] Trial Registered Prospectively
Last Modified On: 30/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Studying the effects of combining psychological treatment in addition to usual care of panic disorder in a tertiary center 
Scientific Title of Study   To study the effect of Psychoeducation with and without CBT for the management of Panic Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
No other ID  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preeti Singh 
Designation  Clinical Psychologist 
Affiliation  Pt. Jawahar Lal Nehru Memorial Medical College 
Address  Department of Psychiatry Pt. Jawahar Lal Nehru Memorial Medical College Jail Rd, Opp central Jail, Moudhapara, Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  8763761179  
Fax    
Email  preeti.c.psychologist@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Preeti Singh 
Designation  Clinical Psychologist 
Affiliation  Pt. Jawahar Lal Nehru Memorial Medical College 
Address  Department of Psychiatry Pt. Jawahar Lal Nehru Memorial Medical College Jail Rd, Opp central Jail, Moudhapara, Raipur


CHHATTISGARH
492001
India 
Phone  8763761179  
Fax    
Email  preeti.c.psychologist@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Preeti Singh 
Designation  Clinical Psychologist 
Affiliation  Pt. Jawahar Lal Nehru Memorial Medical College 
Address  Department of Psychiatry Pt. Jawahar Lal Nehru Memorial Medical College Jail Rd, Opp central Jail, Moudhapara, Raipur


CHHATTISGARH
492001
India 
Phone  8763761179  
Fax    
Email  preeti.c.psychologist@gmail.com  
 
Source of Monetary or Material Support  
Pt Jawahar Lal Nehru Memorial Medical College, Govt of Chhatisgarh,Raipur,PIN- 492001 
 
Primary Sponsor  
Name  Self 
Address  Clinical Psychologist, Psychiatry Department, Pt. Jawahar Lal Nehru Memorial Medical College, Raipur 
Type of Sponsor  Other [Self financed] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti Singh  Jawahar Lal Nehru Memorial Medical College  Department of Psychiatry
Raipur
CHHATTISGARH 		 8763761179

preeti.c.psychologist@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Pt Jawahar Lal Nehru Memorial Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F410||Panic disorder [episodic paroxysmal anxiety],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cognitive behaviour therapy and usual care  Emphasizing on Exposure and cognitive restructuring sessions. Twice in week, 9-10 sessions of 45 minutes to 1 hour 
Intervention  Psycho-education and usual care  Step 1: Education about biological reaction through the perspective of Sympathetic and Parasympathetic Nervous System. Step 2: Give an example of real threat and Autonomous Nervous System arousal. Step 3: Expose the client a normal physical activity (running on stairs) and observe the bodily symptoms through the perspective of Sympathetic arousal and Parasympathetic activity. Step 4: Discussion about occurrence, causes, persistence, normalization and frequency of bodily symptoms in Panic Disorder. Twice in week, 3-4 sessions of 45 minutes  
Intervention  Psychoeducation, cognitive behaviour therapy and usual care  Both psychoeducation and CBT will be administered here. Twice in week, 13-14 sessions of 45 minutes to 1 hours.  
Comparator Agent  Usual care  Treatment as usual in Panic disorder without psychoeducation and cognitive behaviour therapy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Consent and education at least up to 8th class. 
 
ExclusionCriteria 
Details  Current psychosis and severe suicidal intent 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Panic Disorder Severity Scale   Baseline(0 week), end of therapy sessions (8 weeks) and at minimum follow up of 2 months of post-treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Hamilton Anxiety Rating Scale  Baseline(0 week), end of therapy sessions (8 weeks) and at minimum follow up of 2 months of post-treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a randomized trial of psychoeducation with and without cognitive behaviour therapy in Panic disorder patients. The primary outcome measure is Panic disorder severity scale which will be assessed at baseline, end of therapy sessions and at followup.  
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