RecruitingACTRN12625001145493

Development and testing of a Self-Inquiry based psychological program for managing well-being, anxiety and depression in medical students.


Sponsor

Abishkar Thapa (Brain and Neuroscience Centre, Lazimpat, Nepal)

Enrollment

88 participants

Start Date

Sep 2, 2025

Study Type

Interventional

Conditions

Summary

Background and rationale: Many health professionals, particularly medical students, suffer from anxiety and depression. What we experience as ourselves is termed as the Perceptual Self, and it plays an important role in the development of these conditions. There is need for low cost intervention based on the Self-Inquiry method, which is a direct and honest observation of the Self, its structure, and activity. Objective: To develop and test a psychological program based on Self-Inquiry to improve well-being and prevent anxiety and depression in medical students. Hypothesis: We think that a psychological program based on Self-Inquiry can help young adults, such as medical students, to improve their well-being and prevent anxiety and depression.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Medical school is demanding, and many medical students experience anxiety and depression during their training. This study is developing and testing a psychological programme based on a practice called Self-Inquiry — a method of honest, direct observation of your own thoughts, feelings, and sense of self — to help first-year medical students maintain their wellbeing and prevent mental health difficulties. The programme is designed to give students practical tools for understanding and managing their inner experience, with the aim of building psychological resilience before anxiety and depression take hold. Participants will take part in the programme and complete questionnaires measuring their mental health and wellbeing. You may be eligible if you are a first-year medical student who can provide written informed consent. People with serious physical illness, significant mental health conditions that require medical treatment, or who are pregnant are not eligible to participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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: 20-25 per group 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, 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.


Locations(1)

Bagmati, Nepal

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ACTRN12625001145493


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