CTRI/2024/12/077912 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On:
20/11/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Other (Specify) [Psychotherapeutic]
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to evaluate the effectiveness of Brief Interpersonal Psychotherapy in reducing suicidal ideation and attempts among youth with suicide attempts
Scientific Title of Study
Effectiveness and Feasibility of Brief Interpersonal Psychotherapy (B-IPT) among youth with suicide attempts: A Randomized Controlled 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
Dhanpati Sahu
Designation
PhD Scholar
Affiliation
RIMS, Ranchi
Address
Department of Psychiatry, RIMS, Ranchi Pin-834009, Jharkhand Ranchi JHARKHAND 834009 India
Phone
9006728762
Fax
Email
dhanusahu95@gmail.com
Details of Contact Person Scientific Query
Name
Dhanpati Sahu
Designation
PhD Scholar
Affiliation
RIMS, Ranchi
Address
Department of Psychiatry, RIMS, Ranchi Pin-834009, Jharkhand Ranchi JHARKHAND 834009 India
Phone
9006728762
Fax
Email
dhanusahu95@gmail.com
Details of Contact Person Public Query
Name
Dr Ajay Kumar Bakhla
Designation
Professor and HOD of Psychiatry
Affiliation
RIMS, Ranchi
Address
Department of Psychiatry, Rajendra Institute of Medical Sciences (RIMS), Ranchi
Pin-834009, Jharkhand Department of Psychiatry, RIMS, Ranchi
Pin-834009, Jharkhand Ranchi JHARKHAND 834009 India
Phone
9835193088
Fax
Email
ajaybakhla@gmail.com
Source of Monetary or Material Support
Rajendra Institute of Medical Sciences, Ranchi, Pin-834009, State-Jharkhand, India
Primary Sponsor
Name
Dhanpati Sahu
Address
Principal investigators/PhD scholar, Department of Psychiatry, RIMS Ranchi, PIN-834009, Jharkhand, India
Type of Sponsor
Other [Self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ajay Kumar Bakhla
Rajendra Institute of Medical Sciences (RIMS), Ranchi
Room no.Nil, Child Guidance Clinic, OPD Psychiatry, Department of Psychiatry Ranchi JHARKHAND
This module will be Ultra Brief Crisis Interpersonal Psychotherapy (UBC-IPT), a session once a week for up to 5 weeks. Each session will last 60 minutes. In IPT, 4 interpersonal issues are identified: grief and loss, interpersonal disputes, and role transitions are the primary focus of treatment. This therapy will be conducted after training in IPT with respective IPT therapists/clinicians with necessary modifications per patients’ needs. It will be adapted upon request from Klomek et al., 2021. The first and last sessions will be face-to-face, and the middle session will be an audio conference. The experimental group can also access medication and the Telemanas facility. The total duration of the intervention will be 5 hours in five session.
Comparator Agent
Enhance usual care
Enhanced usual care (EUC): Due to participants with high risk, controlled group participants with suicide attempts will be engaged in brief counselling and medication as per patients needs. The duration of brief counselling will be a maximum of 60 minutes during the study period. that may be divided into 5-10 minutes of counselling every week by audio conference to maintain blinding. Brief Counselling will be provided to the patient and their family, in which the researcher will help the participants find available alternative options, meaning or importance in life. The degree of enhancement can range from minimal to extensive, such as each participant will be well-communicated about his/her future risk behaviours or intrusive thoughts of suicidal intent, and they can call TeleMANAS anytime (24/7).
Inclusion Criteria
Age From
14.00 Year(s)
Age To
29.00 Year(s)
Gender
Both
Details
(A) Inclusion Criteria for Experimental Group
1. Patients with a suicide attempt(s)
2. Patients who will attend emergency service at RIMS, Ranchi
3. Age ranges between 15-29 years
4. Patients and their caregivers who will give written informed consent.
5. Participants who will be able to comprehend Hindi and English.
6. Participants who will receive enhanced usual care plus brief interpersonal psychotherapy
(B) Inclusion Criteria for Control Group
1. Patients with a suicide attempt(s)
2. Patients who will attend emergency service at RIMS, Ranchi
3. Age ranges between 15-29 years
4. Patients and their caregivers who will give written informed consent.
5. Participants who will be able to comprehend Hindi and English.
6. Participants who will receive enhanced usual care only
ExclusionCriteria
Details
(C)Exclusion Criteria
1. Patients who will be illiterate.
2. Patients who will have a significant history of delirium, seizure disorders, psychotic symptoms, intellectual disability and any surgical complications
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the effectiveness of brief interpersonal psychotherapy on suicidal ideation and attempts in comparison to enhanced usual care in participants with suicide attempts at the end of five sessions of intervention.
one month
Secondary Outcome
Outcome
TimePoints
• To evaluate the effectiveness of brief interpersonal psychotherapy on symptoms of depression in comparison to enhanced usual care in participants with suicide attempts at the end of sessions of intervention.
one month
• To evaluate the effectiveness of brief interpersonal psychotherapy on symptoms of anxiety in comparison to enhanced usual care in participants with suicide attempts at the end of five sessions of intervention.
one month
Target Sample Size
Total Sample Size="84" Sample Size from India="84" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol Response - Informed Consent Form Response (Others) - Participant information sheet
Who will be able to view these files? Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response - Proposals should be directed to [dhanusahu95@gmail.com].
For how long will this data be available start date provided 03-06-2026 and end date provided 03-12-2027? Response - Beginning 3 months and ending 5 years following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - Nil
Brief Summary
Many bodies of research concluded that individuals with suicide attempts suffer from depressive symptoms and suicidal ideations after usual care and follow-up. The findings of many studies indicated that interpersonal psychotherapy (IPT) has given promising results in managing and preventing many mental health problems, such as depression and suicidal ideations. There was a substantial lack of effectiveness of IPT among individuals with suicide attempts with proper reporting of results with effect size and 95% CI with significant or without significant p-value. So in this study, the researcher will focus on evaluating the effectiveness of IPT on suicidal ideation, attempts, and associated depressive and anxiety symptoms among youth with suicide attempts compared to enhanced usual care adopting a brief therapeutic approach.