Qualitative Research on Women With Congenital Adrenal Hyperplasia (CAH)

This study has been completed.
Information provided by:
Lehigh University
ClinicalTrials.gov Identifier:
First received: November 15, 2007
Last updated: November 6, 2009
Last verified: November 2009
This qualitative interview-based study will investigate the impact that living with congenital adrenal hyperplasia has for women in the following areas: health-related quality of life (HRQL), psychological health, and health-seeking behaviors.

Condition Intervention
Congenital Adrenal Hyperplasia
Other: Interview

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Health-related Quality of Life, Mental Health and Psychotherapeutic Considerations for Women Diagnosed With a Disorder of Sexual Development: Congenital Adrenal Hyperplasia

Resource links provided by NLM:

Further study details as provided by Lehigh University:

Primary Outcome Measures:
  • Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographic Questionnaire [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: July 2007
Study Completion Date: May 2009
Groups/Cohorts Assigned Interventions
Women diagnosed with CAH (either simple virilizing or salt-losing)
Other: Interview
Hour-long, qualitative, phone interview

Detailed Description:
Congenital Adrenal Hyperplasia is a chronic-illness requiring life-long treatment and is caused by an inherited enzyme deficiency that leads to an overproduction of hormones produced by the adrenal glands, which in turn, masculinizes the female genitalia before birth. While the mechanisms by which CAH influences physiological development are understood, the impact of this hormonal elevation on health-related quality of life (HRQL), psychological health, and health-seeking behaviors is less clear. This study is guided by three research questions: (1) how does CAH influence HRQL domains (physical, functional, emotional and interpersonally), (2) how does CAH influence the mental health of women diagnosed with CAH, and (3) how does CAH influence decisions to seek help from a counselor? Semi-structured qualitative interviews will be conducted with women with CAH. Interviews will be analyzed through the Consensual Qualitative Research (CQR) methodology.

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with CAH (either simple-virilizing or salt-losing types) living in the United States

Inclusion Criteria:

  • 46XX, Females
  • Diagnosed by a physician with CAH (either simple-virilizing or salt-losing types)
  • Willing to complete a brief demographic questionnaire and participate in an hour long telephone interview

Exclusion Criteria:

  • Non-classical or late-onset CAH
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00559078

United States, Pennsylvania
Lehigh University
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
Lehigh University
Study Director: Matthew A Malouf, BA Lehigh University Counseling Psychology
Principal Investigator: Arpana G Inman Lehigh University Counseling Psychology
  More Information

No publications provided

Responsible Party: Matthew Malouf, Lehigh University
ClinicalTrials.gov Identifier: NCT00559078     History of Changes
Other Study ID Numbers: 1-Malouf 
Study First Received: November 15, 2007
Last Updated: November 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh University:
Adrenal Hyperplasia, Congenital
Psychosexual Development
Sexual Development
Disorder of Sex Development
Quality of Life
Mental Health

Additional relevant MeSH terms:
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Congenital Abnormalities
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Gonadal Disorders
Metabolic Diseases
Metabolism, Inborn Errors
Pathologic Processes
Steroid Metabolism, Inborn Errors
Urogenital Abnormalities

ClinicalTrials.gov processed this record on February 11, 2016