| 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
|
|
|
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
|
|
|
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. |