| CTRI Number |
CTRI/2025/11/097899 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to examine the utility of grief therapy for women who have experienced loss of a pregnancy or a newborn |
|
Scientific Title of Study
|
Integrated Grief Therapy for Women Survivors Of Perinatal Loss A Feasibility study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwathi PG |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology, M V Govindaswamy Centre, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9566145840 |
| Fax |
|
| Email |
pgashwathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena A Satyanarayana |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Room 312, 3rd Floor, Department of Clinical Psychology, M V Govindaswamy Centre, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9686862686 |
| Fax |
|
| Email |
veenas@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Veena A Satyanarayana |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Room 312, 3rd Floor, Department of Clinical Psychology, M V Govindaswamy Centre, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9686862686 |
| Fax |
|
| Email |
veenas@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, NIMHANS, Bangalore |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
Hosur Road/Marigowda Road (Lakkasandra, Wilson Garden),
Bengaluru 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ashwathi PG |
National Institute of Mental Health and Neurosciences |
Department of Clinical Psychology, M V Govindaswamy Centre, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road,
Bengaluru
Bangalore
KARNATAKA |
9566145840
pgashwathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health and Neurosciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F438||Other reactions to severe stress, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Grief Therapy |
Integrated grief therapy will primarily adapt the grief therapy model proposed by Neimeyer (2016). It will address grief through techniques
such as emotional regulation, imaginal dialogue, legacy projects, self-care strategies, relational compassion and psychological security.
The exact components of the Integrated Grief Therapy will be finalized during the formative phase of the study, based on- 1. qualitative interviews with women with a lived experience of perinatal loss, and 2. validation by experts in the field of perinatal mental health.
The integrated grief therapy will be carried out over 8 individual, weekly sessions, approximately 60 minutes with the woman who has survived perinatal loss. One elective session for spouse on perinatal grief will also be provided. Therapy will be delivered in a hybrid mode; initially face-to-face and later online based on the participant’s preference. The study measures will be administered at baseline, at 4 weeks, post intervention; at 8 weeks, and at 8-10 weeks follow-up. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women who score above 20 on Kessler Psychological Distress scale following perinatal loss, indicating clinically significant level of psychological distress.
Women who have experienced perinatal loss in the past 12 months.
Primiparous or multiparous women.
Women who are married.
Women who are fluent in speaking English or Tamil |
|
| ExclusionCriteria |
| Details |
Women who are acutely physically or psychologically distressed and unable to engage in assessment or psychotherapy.
Women with a history of perinatal loss who are currently pregnant.
Women diagnosed with severe mental health disorders like severe depression, bipolar affective disorder, severe suicidal risk and affective and non-affective psychosis.
Women identified with intellectual difficulties on clinical examination.
Women with neurological or organic brain conditions.
Women who are currently receiving therapy for perinatal grief |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perinatal Grief |
Measured at
1. Baseline
2. At 4 weeks
3. Post intervention; at 8 weeks
4. At 8-10 weeks follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wellbeing |
Baseline, at 4 weeks, post
intervention; at 8 weeks, and at 8-10 weeks follow-up. |
| Meaning Making |
Baseline, at 4 weeks, post intervention; at 8 weeks, and at 8-10 weeks follow-up. |
| Process of therapy |
At 4 weeks, post
intervention; at 8 weeks, and at 8-10 weeks follow-up. |
| Feasibility assessment |
Post intervention at 8 weeks |
| |
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/02/2026 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The current study aims to examine the feasibility and effectiveness of integrated grief therapy on mental health and meaning making for women survivors of perinatal loss. It will utilize a single group, pre-mid-post-follow-up design with two phases; formative and therapy phase. The sample; women between 19 and 45 years of age, who have experienced perinatal loss in the past 12 months, will be recruited from the perinatal psychiatry services at NIMHANS, an obstetrics and gynecology (OBG) specialty hospital in Bengaluru, and from appropriate online social media platforms. In the formative phase, women, n=5 who have survived perinatal loss will be interviewed. Themes from the interviews will be combined with a detailed literature review to compile and adapt the proposed integrated grief therapy, which will be validated by experts, n=5 in the field of perinatal medical and mental health, women’s mental health or grief therapy. In the therapy phase, a sample of n=30 consenting women who meet the inclusion criteria will be enrolled for integrated grief therapy, which includes 8 weekly individual sessions and 1 elective session for the spouse. Select study measures will be administered at different time points; baseline, mid-intervention (after 4 sessions), post intervention, and follow-up after 8- 10 weeks. Study measures include Kessler Psychological Distress Scale (K-10) for screening, antecedent measures include Adverse Childhood Experiences Questionnaire (ACE-Q), Experiences in Close Relationships Scale– Short form (ECR-S), Dyadic Adjustment Scale-7 (DAS-7), and Social Provisions Scale-5 (SPS-5), outcome measures include Perinatal Grief Scale (PGS), WHO-5 Well-being scale (WHO-5), Grief and Meaning Reconstruction Inventory (GMRI), Helpful Aspects of Therapy form as a measure of therapy process, and a measure of feasibility which is to be developed. The findings from the feasibility study could help in planning future controlled trials and also have important clinical implications for improving psychotherapy services in diverse settings for women and couples who have survived perinatal loss. |