Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001145493
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/07/2025
Date registered
Help: Date registered
20/10/2025
Date last updated
Help: Date last updated
21/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
20/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Development and testing of a Self-Inquiry based psychological program for managing well-being, anxiety and depression in medical students.
Scientific title
Development and testing of a Self-Inquiry based psychological program for managing well-being, anxiety and depression in medical students.
Additional trial identifiers [1] 314759 0
nihr24028
Universal Trial Number (UTN)
U1111-1324-5813
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Depression 337979 0
Anxiety 337980 0
Wellbeing 337981 0
Condition category
Condition code
Mental Health 334294 334294 0 0
Depression
Mental Health 334295 334295 0 0
Anxiety
Alternative and Complementary Medicine 334296 334296 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
We have developed a group psychological intervention based on Self-inquiry named Perceptual Self-inquiry. The Perceptual Self, what we experience as ourselves, plays a significant role in maintaining well-being. Self-inquiry is an intellectual introspection and observation of oneself, thoughts and experiences to get a deeper understanding. Traditionally, Self-inquiry is focused on finding out the true Self/ the awareness beyond the Perceptual Self in which the thoughts and emotions are playing. However, in this approach, we are focused on inquiring about the Perceptual Self, the psychological and experiential constituents of the Self, including Self-concepts.
Hence, we define Perceptual Self-Inquiry as a direct and honest observation of the Perceptual Self, its structure, and activity. The basis of this approach to Self-Inquiry is to understand the Perceptual Self through observation of thoughts and experiences. Through understanding the Perceptual Self, we envision individuals gaining clarity and living life free of psychological conflicts independently.

The Self is referred to as “I” in conversation and internally. Whenever there is some problem, e.g. when someone says I am sad, we might immediately jump to solve the sadness without first understanding what is being referred to as I. “I” is a word, and it is being used to describe the experience of the Self being experienced at that moment. When we understand what is being referred to as I, it becomes easier to solve the problem within the I.

Intervention Overview

Structure
Format: Group Inquiry sessions
Number of participants: 44-50 participants
Length: Eight sessions, each lasting one to one and a half hours
Frequency: Weekly

Delivery Format
Mode: In-person
Location: Medical College

Facilitation: The Facilitator, also the principal investigator, has been practising Self-inquiry for 5 years and has conducted multiple sessions for the last 3 years. The facilitator will have a manual with the content of the sessions and instructions on how to run the sessions.

Inquiry-based: The participants need not believe what is being presented but rather question and introspect. The sessions have been designed to encourage participants to question what is presented by the facilitator and their own thoughts objectively. The facilitator will pose questions to encourage participants to think for themselves, present concepts of Perceptual Self-Inquiry, and encourage discussion and questioning of the concepts. Each topic will have engaging questions for the participants before providing an explanation.



Aiding tools: Most of the sessions will have interactive and illustrative diagrams and or audio-visual as aiding tools to clarify the concepts.

Self-practice: The participants are encouraged to practise inquiry on their own and discuss any challenges faced.

Study site selection
Two medical colleges with comparable academic environments will be selected as our study population consists of first-year medical students. A list of medical colleges in Kathmandu Valley will be made and grouped according to their University affiliation. We are limited to the Kathmandu Valley because the research team is mostly based in Kathmandu, and the budget restricts us from travelling and conducting the study outside of the valley. Choosing Kathmandu Valley as our study site will also help minimise socio-cultural differences in the environment, ensuring a comparable context for all participants.
The medical colleges will further be sub-grouped into Private, Semi-government, and Government-run institutes. If two medical colleges fall under the same subgroup, they will be approached first. The priority will be to select two medical colleges within the same subgroup. If that is not possible, medical colleges within the same group will be chosen.

The allocation to either intervention group or the comparator will be done at the institutional level. Hence, one medical college will be assigned to receive the intervention, and another will be the comparator group. This assignment of the medical colleges into different arms has been chosen to prevent spillover of the intervention, as it is mostly educational. The sampling will be done based on convenience and feasibility. If there is no subjective difference in convenience and feasibility, i.e. both colleges are keen to be the intervention arm, simple random sampling will be used.
The comparator group will receive the usual care. The usual care includes any pathway to mental health care or any programs run by the medical college for the well-being of medical students. Given that the intervention shows a positive impact and is accepted by the intervention group, it will also be offered to the comparator group.

Participant selection in each medical college:
All the first-year medical students in the medical college will be reached out to and informed about the study, including the inclusion and exclusion criteria of the study. The first screening will be self-proclaimed, i.e. if the participants think the exclusion applies to them or they don't want to participate, they can opt not to take part in the study. Then, after taking informed consent, the participants will be asked to fill out the questionnaire, which includes the Hopkins Symptom Checklist-25 (HSCL-25). In cases where participants are found to have severe anxiety/depression and or suicidal thoughts, they will be reached out to individually and further evaluated by a psychiatrist. After the evaluation, a decision will be reached on the basis of a mutual decision by the Psychiatrist and the participants, whether to continue with the study or step out of it.
If more students than the sample size, i.e. 88, of the study remain, forty-four students will be randomly selected in each medical college to continue with the study. However, for a qualitative study, purposive sampling techniques will be used, including maximum variation and deviant cases.

Role of the facilitator:

The facilitator will guide the participants through the inquiry sessions, ask questions, engage the participants, and provide explanations while encouraging Self-practice.

Role of the participants in the intervention:

To participate, inquire about the topic of discussion, raise questions, and Self-practice.


Topics for each session:

Session 1: Introduction to Perceptual Self-inquiry
Session 2: Experience, memory, thought, and the Self
Session 3: The Functional Self and the Whole Self
Session 4: The identity
Session 5: The environment, people, situation, and the Self
Session 6. The inquiry
Session 7: Discussion on the problems that arose during the practice
Session 8: Continuation of Session 7 and Consolidation

Acceptability and Feasibility:

The quantitative data on the acceptability and feasibility of the intervention, such as the percentage of students who give informed consent, will also be collected. Moreover, we will also ask the participants to provide the reasons for enrollment and decline. After each session, the participants will be given a feedback form to rate different aspects of the intervention.
The adherence of the participants will be measured by calculating the dropout rate and the percentage of students who complete all sessions using an attendance sheet. The reasons for dropping out will be asked in the post-intervention questionnaire. The frequency of practice of Self-Inquiry independently beyond the sessions will also be measured.

Focused Group Discussions(FGDs):

A small group (8-10 participants) FGDs will be conducted to:
1. Explore participants' overall experience of the intervention, changes they noticed, and challenges/difficulties during and while practising the intervention.
2. Explore the mechanisms of the experience’s participants describe.
3. Participants' feedback for improvement of the intervention and facilitation

We will select participants purposively to have a diverse view. Hence, we will include participants from all age groups, sexes and nationalities. Also, people who were engaged during the intervention and those who were not seem to be. We will also include those who benefited from the intervention and those who felt otherwise. The FGD will be held during two months' follow-up after the preliminary analysis of both quantitative data and semi-structured interviews.

The FGDs will be conducted by the Research Assistants of the study. The facilitator will not be present to help students open up.





Intervention code [1] 331359 0
Prevention
Intervention code [2] 331360 0
Treatment: Other
Intervention code [3] 331361 0
Lifestyle
Description of the comparator or control
The partcipant will receive usual care provided in their setting. Currently they receive mental health care on need basis.
Control group
Active

Outcomes
Primary outcome [1] 341963 0
Depression
Timepoint [1] 341963 0
Baseline, Immediately post intervention (within 7 days) and at two months follow-up
Primary outcome [2] 341964 0
Wellbeing
Timepoint [2] 341964 0
Baseline, immediately post intervention(0-7days) and at two months follow-up.
Primary outcome [3] 341966 0
Anxiety
Timepoint [3] 341966 0
Baseline, immediately post intervention(0-7days) and at two months follow-up.
Secondary outcome [1] 449167 0
Self-focused attention
Timepoint [1] 449167 0
Baseline, immediately (0-7 days) post intervention and at two months follow-up.
Secondary outcome [2] 449188 0
Intra-personal conflict resolution
Timepoint [2] 449188 0
Immediately post interevention (0-7 days) and at two months follow-up.
Secondary outcome [3] 449189 0
Fidelity of the facilitator
Timepoint [3] 449189 0
During each intervention session. Checklist will be made specific to each session.
Secondary outcome [4] 450603 0
Feasibility and acceptability of the study (As composite measure)
Timepoint [4] 450603 0
Once during enrollment, during each session, once immediately post intervention(0-7 days) and once at two months follow-up.

Eligibility
Key inclusion criteria
Medical students in their first year of medical school
Provides written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Serious physical illness, making it difficult to participate
Serious mental health status based on initial screening with study tools and clinical assessment, making it unsafe to participate or requiring medical treatment
Pregnancy (Self-reported)
Unwillingness to participate

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
13/04/2026
Date of last participant enrolment
Anticipated
7/11/2025
Actual
19/04/2026
Date of last data collection
Anticipated
14/10/2026
Actual
Sample size
Target
88
Accrual to date
Final
58
Recruitment outside Australia
Country [1] 27156 0
Nepal
State/province [1] 27156 0
Bagmati

Funding & Sponsors
Funding source category [1] 319309 0
Charities/Societies/Foundations
Name [1] 319309 0
The Royal Society of Tropical Medicine and Hygiene
Country [1] 319309 0
United Kingdom
Funding source category [2] 319321 0
Government body
Name [2] 319321 0
National Institute for Health Care and Research
Country [2] 319321 0
United Kingdom
Primary sponsor type
Individual
Name
Abishkar Thapa (Brain and Neuroscience Centre, Lazimpat, Nepal)
Address
Country
Nepal
Secondary sponsor category [1] 321808 0
Commercial sector/Industry
Name [1] 321808 0
Brain and Neuroscience Centre, Nepal
Address [1] 321808 0
Country [1] 321808 0
Nepal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317890 0
Nepal Health Research Council
Ethics committee address [1] 317890 0
Ethics committee country [1] 317890 0
Nepal
Date submitted for ethics approval [1] 317890 0
24/02/2025
Approval date [1] 317890 0
14/05/2025
Ethics approval number [1] 317890 0
2503
Ethics committee name [2] 317903 0
Kathmandu Medical College, Institutional Review Committee
Ethics committee address [2] 317903 0
Ethics committee country [2] 317903 0
Nepal
Date submitted for ethics approval [2] 317903 0
22/02/2025
Approval date [2] 317903 0
02/04/2025
Ethics approval number [2] 317903 0
02042025/15
Ethics committee name [3] 317904 0
Nepal Medical College, Institutional Review Board
Ethics committee address [3] 317904 0
Ethics committee country [3] 317904 0
Nepal
Date submitted for ethics approval [3] 317904 0
28/03/2025
Approval date [3] 317904 0
17/06/2025
Ethics approval number [3] 317904 0
47-081/082

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142474 0
Dr Abishkar Thapa
Address 142474 0
Brain and Neuroscience Centre (BANC, Nepal), Lazimpat, Ward no. 02, Kathmandu, Bagmati, Nepal
Country 142474 0
Nepal
Phone 142474 0
+977 9849200954
Fax 142474 0
Email 142474 0
[email protected]
Contact person for public queries
Name 142475 0
Abishkar Thapa
Address 142475 0
Brain and Neuroscience Centre (BANC, Nepal), Lazimpat, Ward no. 02, Kathmandu, Bagmati, Nepal
Country 142475 0
Nepal
Phone 142475 0
+977 9849200954
Fax 142475 0
Email 142475 0
[email protected]
Contact person for scientific queries
Name 142476 0
Abishkar Thapa
Address 142476 0
Brain and Neuroscience Centre (BANC, Nepal), Lazimpat, Ward no. 02, Kathmandu, Bagmati, Nepal
Country 142476 0
Nepal
Phone 142476 0
+977 9849200954
Fax 142476 0
Email 142476 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To maintain participants confidentiality.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    NHRC approval.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.