| CTRI Number |
CTRI/2025/11/097952 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A talking therapy can help people with long lasting sadness and low mood |
|
Scientific Title of Study
|
Effectiveness Of acceptance and commitment therapy (ACT) on treatment outcomes among patients with depression at mental health centre Of North Bengal |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjana Pal |
| Designation |
Ph D Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Ph D Section Ground Floor Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University National Highway 24 Delhi Road Bagadpur Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7864850696 |
| Fax |
|
| Email |
ranjana.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Suman Vashist |
| Designation |
Professor and Supervisor |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Room No 109 Ground Floor Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University National Highway 24 Delhi Road Bagadpur Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9915650484 |
| Fax |
|
| Email |
suman.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Nirmal Kumar Bera |
| Designation |
HOD and Professor |
| Affiliation |
North Bengal Medical College and Hospital |
| Address |
Room No 32 Psychiatry OPD North Bengal Medical College and Hospital Sushrutanagar District Darjeeling Siliguri West Bengal India
Darjiling
WEST BENGAL
734012
India |
| Phone |
9434006972 |
| Fax |
|
| Email |
drbera@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| North Bengal Medical College and Hospital Sushruta Nagar District Darjeeling Siliguri West Bengal India Pincode 734012 |
|
|
Primary Sponsor
|
| Name |
Ranjana Pal |
| Address |
Teerthanker Mahaveer College of Nursing Ph D Cell Teerthanker Mahaveer University National Highway 24 Delhi Road Bagadpur Moradabad Uttar Pradesh Pincode 244001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nirmal Kumar Bera |
North Bengal Medical College and Hospital |
Room No 32 Psychiatry OPD Sushrutanagar District Darjeeling Siliguri West Bengal India Pincode 734012
Darjiling
WEST BENGAL |
9434006972
drbera@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government of West Bengal North Bengal Medical College Darjeeling Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acceptance Commitment Therapy |
The Acceptance Commitment Therapy sessions include educational sessions, emotional support and self-care strategies by situation analysis, self-reflection, experimental avoidance, value clarification and positive thinking strategies. The total duration will be 1.5 years. |
| Comparator Agent |
Routine Support |
Depressive patients will receive the usual treatment and informal support provided as a part of standard care. The total duration will be 1.5 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients experiencing depressive symptoms for more than three months
Patients within 18 to 60 years of age
Patients who are attending mental health centre of North Bengal
Patients who can understand english or bengali or nepali or hindi language
Patients who are willing to take participation
Patients who are available during the time of data collection
|
|
| ExclusionCriteria |
| Details |
Patients experiencing depressive symptoms for less than three months
Patients with less than 18 years or more than 60 years ofage
Patients who are not attending mental health centre of North Bengal
Patients who can not understand english or bengali or nepali or hindi language
Patients who are not willing to take participation
Patients who are not available during the time of data collection
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in depression greater psychological flexibility improved quality of life and high patient satisfaction |
20 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/12/2025 |
| 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="8"
Days="16" |
|
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
|
Depression is a growing mental health concern in India affecting nearly 23 million adults with a lifetime prevalence of 5 point 25 percentage and higher rates among women and individuals aged 40 to 59 while in Darjeeling West Bengal 36 percentage of adults show depressive symptoms highlighting the urgent need for effective interventions such as Acceptance and Commitment Therapy Acceptance and Commitment Therapy is a modern behavioral psychotherapy derived from CBT emphasizes acceptance mindfulness and values based living to enhance psychological flexibility Research shows ACT effectively reduces anxiety and stress while improving quality of life across diverse populations This study aims to evaluate the effectiveness of ACT in reducing depressive symptoms enhancing psychological flexibility and improving quality of life among patients with depression attending mental health centre Using a quantitative true experimental design 100 depressive patients will be randomly assigned to experimental and control group 50 participants in each group with the intervention group receiving eight structured weekly sessions involving mindful breathing cognitive defusion and values based action Outcomes will be measured using the Beck Depression Inventory Acceptance Action Questionnaire WHOQOL BREF Scale and Short Assessment of Patient Satisfaction with data collected at baseline 2 months 4 months and 6 months and analyzed using t tests ANOVA correlations and chi square Expected results include significant reductions in depression greater psychological flexibility improved quality of life and high patient satisfaction with findings contributing to evidence supporting ACT as a cost effective patient centered therapy suitable for resource limited rural Indian settings |