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CTRI Number  CTRI/2025/05/086655 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 09/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Couple-Based Support for Perinatal Mental Health 
Scientific Title of Study   Couple-Centred Brief Intervention (CCBI) for Common Perinatal Mental Disorders among Parental Dyads during First Year of Child Birth: A Parallel Group, Non-Inferiority Trial  
Trial Acronym  CCBI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pracheth R 
Designation  Associate Professor Department of Epidemiology 
Affiliation  NIMHANS Bengaluru 
Address  Room No 219 Department of Epidemiology Second Floor Dr MV Govindaswamy Centre NIMHANS Hosur Road Bengaluru 560029

Dakshina Kannada
KARNATAKA
560029
India 
Phone  08026972017  
Fax    
Email  prach1986@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pracheth R 
Designation  Associate Professor Department of Epidemiology 
Affiliation  NIMHANS Bengaluru 
Address  Room No 219 Department of Epidemiology Second Floor Dr MV Govindaswamy Centre NIMHANS Hosur Road Bengaluru 560029

Dakshina Kannada
KARNATAKA
560029
India 
Phone  08026972017  
Fax    
Email  prach1986@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pracheth R 
Designation  Associate Professor Department of Epidemiology 
Affiliation  NIMHANS Bengaluru 
Address  Room No 219 Department of Epidemiology Second Floor Dr MV Govindaswamy Centre NIMHANS Hosur Road Bengaluru 560029

Dakshina Kannada
KARNATAKA
560029
India 
Phone  08026972017  
Fax    
Email  prach1986@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India.  
 
Primary Sponsor  
Name  NIMHANS 
Address  National Institute of Mental Health and Neuro Sciences, Hosur Road/Marigowda Road Lakkasandra, Wilson Garden, Bengaluru 560029 India 
Type of Sponsor  Government medical college 
 
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 Pracheth R  NIMHANS  Room No 219 Department of Epidemiology Second Floor Dr MV Govindaswamy Building NIMHANS Hosur Road Bengaluru 560029
Bangalore
KARNATAKA 
08026972017

prach1986@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS (BS and NS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (2) ICD-10 Condition: F432||Adjustment disorders, (3) ICD-10 Condition: F411||Generalized anxiety disorder, (4) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Couple Centred Brief Intervention for Common Perinatal Mental Disorders   Includes four sessions of fifteen minutes that will be delivered in-person at an interval of two weeks. The first session includes psychoeducation with a focus on depression and it’s implications in postnatal period and measures to alleviate the same. Relaxation and breathing exercises are the concepts included in the second session which will be conducted two weeks after the first session. The third session carried out two weeks after the second session focuses on health promotion and includes education on nutrition, sleep and social support. The fourth session which will be developed in Phase 1 of this study will focus on relationship-focused strategies, communication skills, problem-solving techniques, mutual support. This session will be delivered jointly to the parental dyad.  
Comparator Agent  Standard of Care   The standard care group will receive assessment and treatment for postpartum depression and anxiety by specialists from District Mental Health Program. This may include individual therapy or medication as recommended by healthcare providers.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  parental dyad postnatal woman and her husband with woman aged 18 years and above who underwent delivery in the past year residing in the study area for more than 6 months and with a score of 10 to 19 on PHQ 9 mild to moderately severe depression and GAD 7 score 10 to 14. 
 
ExclusionCriteria 
Details  Those with PHQ 9 score of 19 and above severe depression and GAD 7 score of 14 and above severe anxiety 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in depression and/or anxiety scores among participants   Four weeks after intervention delivery  
 
Secondary Outcome  
Outcome  TimePoints 
Relationship satisfaction, social support, parenting involvement, obstetric & morbidity profile  4 weeks after intervention delivery  
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="260" 
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   N/A 
Date of First Enrollment (India)   01/09/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Common perinatal mental disorders CPMD like postpartum depression PPD and postpartum anxiety PPA are significant mental health concerns. They not only impact individual well-being but also strain the parental relationship. Interventions for CPMD focus solely on individual treatments, overlooking the systemic nature of the problem within the parental unit. Thus, there is a need for interventions tailored to parental dyads that address both individual and relational factors. There have been no studies focusing on the effectiveness of interventions targeting both the postpartum woman and her partner for CPMD.

This study investigates whether such an intervention will be effective in community settings. Moreover, it will facilitate brief mental health screening of postnatal women, which is a part of postnatal care yet not fully implemented, as per field experiences. Therefore, this study is carried out to investigate the effectiveness of a Couple-Centred Brief Intervention CCBI for mild to moderate PPD and PPA among parental dyads during the first year of childbirth, when compared to standard care treatment recommended by healthcare providers.

This is a randomized controlled trial with two parallel arms, CCBI and Standard Care. Parental dyads will be screened sequentially using the Patient Health Questionnaire PHQ-2, PHQ-9 and the Generalized Anxiety Disorder scales GAD-2 and GAD-7. Either member of the parental dyad with a PHQ-9 score between 10 and 19 or a GAD-7 score between 10 and 14 will be invited to participate and randomly assigned to either the intervention or standard care group. Assessments will be conducted at baseline and at end-points four weeks after the last session of the intervention or standard care.

This trial contributes to the evidence base for interventions targeting CPMD among parental dyads. If successful, it would offer a valuable addition to existing treatment approaches.

 
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