| CTRI Number |
CTRI/2026/04/107379 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Understanding how Emotion Focused Therapy may help women with ovarian cancer cope with emotional distress and fear about disease progression |
|
Scientific Title of Study
|
Effect of emotion focused therapy in emotional regulation, psychological distress and fear of progression in patients with ovarian cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr BP Mishra |
| Designation |
Professor and Head, Dept. of Clinical Psychology, DMCH |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Clinical Psychology, Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
781483339 |
| Fax |
|
| Email |
bholesh@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreya Khatri |
| Designation |
Mphil 2nd year trainee, Dept. of Clinical Psychology, DMCH |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Clinical Psychology, Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana
Ludhiana
PUNJAB
1410001
India |
| Phone |
9650004601 |
| Fax |
|
| Email |
shreya.khatri15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Khatri |
| Designation |
Mphil 2nd year trainee, Dept. of Clinical Psychology, DMCH |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Clinicial Psychology, Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana
Ludhiana
PUNJAB
1410001
India |
| Phone |
9650004601 |
| Fax |
|
| Email |
shreya.khatri15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana, Punjab, India 141001 |
| Type of Sponsor |
Private 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 BP Mishra |
Dayanand Medical College and Hospital |
Department of Clinical Psychology, Dayanand Medical College and Hospital, Civil lines, Tagore nagar, Ludhiana 141001
Ludhiana
PUNJAB |
7814833339
bholesh@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (EIC) Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C56||Malignant neoplasm of ovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control group will be given pharmacological treatment as usual, with no psychotherapuetic intervention. |
| Intervention |
Emotion Focused Therapy |
Leslie Greenbergs Emotion-Focused Therapy (EFT) is an empirically supported, humanistic-experiential approach that views emotion as central to human functioning and therapeutic change. In this study, a 12 session EFT protocol will be used (alongside treatment as usual) to improve psychological distress and facilitate emotional regulation in patients with ovarian cancer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosis of Ovarian Cancer
Patients speak English, Hindi, or Punjabi fluently and have adequate visual and hearing ability.
Minimum Education up to 5th grade.
Patients are willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
History of Intellectual disability.
Patients with any major comorbid psychiatric disorder (Psychotic Disorder, Bipolar Affective Disorder, OCD)
Presence of any major neurological disorder.
Presence of linguistic or cognitive difficulties preventing reliable completion of the questionnaire.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Better scores on post-test assessments |
baseline, post-intervention, 3 months post-intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 2 |
|
Date of First Enrollment (India)
|
30/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/04/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
Aim - To evaluate the effectiveness of
Emotion Focused Therapy (EFT) in improving Emotional Regulation and reducing
Psychological Distress and Fear of Progression in patients with Ovarian Cancer Method - 72 patients will be randomly assigned to either the intervention group receiving
Emotion Focused Therapy along with Treatment as Usual (n=36) or the control group receiving TAU
alone (n=36). Patients will be assessed at baseline, post-intervention, and in
a 3-month follow-up assessment. Clinical Significance - Patients
with Ovarian Cancer show higher levels of psychological distress in the form of
Anxiety, Depression and Stress. They are also more likely to have difficulties
in emotional regulation due to hormonal imbalances caused by various treatment
modalities. Emotion Focused Therapy sessions will be aimed at helping patients
identify different emotions, use emotions to guide action, change unhelpful
emotional cycles, and develop healthy coping strategies. |