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CTRI Number  CTRI/2025/07/091520 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Why being the provider can feel heavy for men in midlife: The hidden struggles of being a husband, father, and son. 
Scientific Title of Study   Traditional Male Role Expectations and Mental Health of Middle Aged Married Men Experiencing Midlife Crisis: A Mixed Method 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  Pallavi Madhu 
Designation  Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology – Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  7594800588  
Fax    
Email  pallavi.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Vaishalee S. 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology – Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9488615322  
Fax    
Email  vaishalee.s@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ms. Samyukta Vaidyanathan 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology – Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8939372782  
Fax    
Email  samyukta.v@manipal.edu  
 
Source of Monetary or Material Support  
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Madhav nagar, Eshwar Nagar, Manipal, Karnataka 576104, India 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Madhav Nagar, Manipal – 576104, Udupi District, Karnataka, India 
Type of Sponsor  Research institution and hospital 
 
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 Vaishalee S  Kasturba Medical College  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Madhav Nagar, Manipal – 576104, Udupi District, Karnataka, India
Udupi
KARNATAKA 		 9488615322

vaishalee.s@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Development of adjustment disorder (ICD-11: 6B43) and other stress-related mental health issues in middle-aged married men. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Inclusion criteria (Phase 1)
Married men aged 40-60 years, with at least one child and Married for at least 5 years, currently living with their spouse

Inclusion Criteria (Phase 2)
Married Middle-Aged Men who meet the criteria of scoring 30 and above on the Developmental Crisis Questionnaire (DCQ-12) administered in Phase 1 and then Married Middle-Aged Men scoring 30 and above on the DCQ-12 who are open and willing to discuss their experiences with midlife crisis.
 
 
ExclusionCriteria 
Details  Exclusion criteria
Married middle-aged men with physical disabilities/chronic medical conditions
Married middle-aged men with a history of mental health conditions
Middle-aged men who are divorced or widowed
Middle-aged men who are the only child in their family
Middle-aged men with a physically challenged child
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is to assess the psychological impact of traditional male roles on married middle-aged men, specifically in relation to their experiences of midlife crisis. This will be measured through responses on the DCQ-12 scale and in-depth qualitative interviews conducted in Phase 2. The outcome will include levels of emotional distress, perceived role burden, emotional suppression, and willingness to seek psychological support.

 		 Outcome assessment will occur at two time points. The baseline assessment will take place during Phase 1, where the DCQ-12 will be administered to all eligible participants. The second assessment point will be during Phase 2, approximately 4 to 8 weeks after the initial screening, where selected participants (based on DCQ-12 scores) will undergo an in-depth qualitative interview to further explore their lived experiences of midlife challenges 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   03/08/2025 
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="0"
Months="11"
Days="0" 
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pallavi.mchpmpl2024@learner.manipal.edu].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 01-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to explore how traditional male role expectations affect the mental health of middle-aged married men experiencing midlife crisis. The research adopts a mixed-methods design, combining quantitative screening using the Developmental Crisis Questionnaire (DCQ-12) with in-depth qualitative interviews. The primary objective is to assess the prevalence of midlife crisis and understand the psychological, familial, and societal challenges faced by this population. The study hypothesizes that strong adherence to traditional male roles is associated with greater emotional distress, difficulty in help-seeking, and reduced mental well-being during midlife. 
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