| CTRI Number |
CTRI/2025/07/092051 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Life for Women with Endometriosis: A Psychological Intervention Study to Enhance Quality of Life and Reduce Depression |
|
Scientific Title of Study
|
Adapting to Better Life with Endometriosis (ABLE): A study to improve quality of life of women with endometriosis and investigate economic burden of the disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 5, Dated 05.05.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preety Rajbangshi |
| Designation |
Senior Research Fellow, Womens Health |
| Affiliation |
The George Institute of Global heaalth, India |
| Address |
308, Third Floor, Elegance Tower, District Centre, Jasola Vihar, New Delhi, Delhi 110025
New Delhi
DELHI
110025
India |
| Phone |
9711414899 |
| Fax |
|
| Email |
PRajbangshi@georgeinstitute.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susmita Chatterjee |
| Designation |
Program Head, Health Economics |
| Affiliation |
The George Institute of Global heaalth, India |
| Address |
308, Third Floor, Elegance Tower, District Centre, Jasola Vihar, New Delhi, Delhi 110025
New Delhi
DELHI
110025
India |
| Phone |
9953770639 |
| Fax |
|
| Email |
schatterjee@georgeinstitute.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Sarah Shabbir Suwasrawala |
| Designation |
Research Fellow |
| Affiliation |
The George Institute of Global heaalth, India |
| Address |
308, Third Floor, Elegance Tower, District Centre, Jasola Vihar, New Delhi, Delhi 110025
New Delhi
DELHI
110025
India |
| Phone |
8451090164 |
| Fax |
|
| Email |
ssuwasrawala@georgeinstitute.org.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR)
V. Ramalingaswami Bhawan,
P.O. Box No. 4911, Ansari Nagar,
New Delhi – 110029,
India |
|
|
Primary Sponsor
|
| Name |
The George Institute of Global Health, India |
| Address |
308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre,
New Delhi, 110025 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Panchanan Das |
Guwahati Medical College and Hospital |
First Floor, Department of Obstetrics and Gynaecology Office,
Gauhati Medical College and Hospital, Kamrup Metropolitan District, Guwahati – 781032, Assam
Kamrup
ASSAM |
9864063488
panchanan_reeti@yahoo.in |
| Dr Ranjitha Shetty |
Kasturba Medical College (KMC) |
Ground Floor, Women and Child Block, Kasturba Hospital, Madhav Nagar Manipal 576104 Udupi District Karnataka
Udupi
KARNATAKA |
9110401395
ranjitha.shetty@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Guwahati Medical College & Hospital |
Approved |
| Kasturba Medical College |
Approved |
| The George Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioral Activation Treatment for Depression (BATD)-based psychological group sessions |
- 8 group sessions over 3-week intervals, including patient education, coping strategies, and mindfulness exercises.
- Homework component includes mindfulness practices via handouts, worksheets, and videos.
|
| Comparator Agent |
Routine Medical and psychological care |
Treatment as usual, including medical and psychological care as routinely provided at the respective sites. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Women will be eligible to participate if they meet all of the following criteria:
1. Aged between 18 and 49 years.
2. Have a confirmed diagnosis of endometriosis, either surgically or via transvaginal ultrasound.
3. Reside within 20 km of the study hospital site.
4. Have a PHQ-9 score of 5 or above, indicating at least mild depressive symptoms.
5. Are willing and able to attend all 8 Behavioral Activation (BA) group sessions.
6. Are willing to engage in homework (30–40 minutes weekly) involving mindfulness activities and worksheets.
$$$$$$
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they meet any of the following:
1. Have a severe psychiatric disorder that impairs their ability to provide consent or attend sessions.
2. Are currently pregnant or planning pregnancy during the study period.
3. Have associated malignancies.
4. Are unable to speak and understand any of the following languages: Hindi, English, Kannada, or Assamese.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in quality of life as measured by WHOQOL-BREF |
6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in depression score using PHQ-9 at 6 and 12 months
2. Incremental cost analysis from provider perspective
|
6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
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 1 |
|
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="1"
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 ABLE study (Adapting to Better Life with Endometriosis) aims to improve the quality of life and reduce depressive symptoms in women diagnosed with endometriosis through a structured psychological intervention based on Behavioral Activation Therapy for Depression (BATD). The study also seeks to assess the economic burden of endometriosis on affected women and their families. This individual randomized controlled trial will be conducted at two sites in India, enrolling 480 participants ( 240 each in the intervention and control arms). Women will be randomized to either an intervention group receiving eight group-based BATD sessions or a control group receiving treatment as usual. Study Hypothesis:
The behavioral activation-based psychological intervention will lead to a significant improvement in quality of life and reduction in depression scores among women with endometriosis compared to standard care. |