Qualitative Research on Women With Congenital Adrenal Hyperplasia (CAH)

November 6, 2009 updated by: Lehigh University

Health-related Quality of Life, Mental Health and Psychotherapeutic Considerations for Women Diagnosed With a Disorder of Sexual Development: Congenital Adrenal Hyperplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Lehigh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women diagnosed with CAH (either simple-virilizing or salt-losing types) living in the United States

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CAH
Women diagnosed with CAH (either simple virilizing or salt-losing)
Other: Interview
Hour-long, qualitative, phone interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographic Questionnaire
Time Frame: 15 minutes
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lehigh University

Investigators

  • Study Director: Matthew A Malouf, BA, Lehigh University Counseling Psychology
  • Principal Investigator: Arpana G Inman, Lehigh University Counseling Psychology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

November 9, 2009

Last Update Submitted That Met QC Criteria

November 6, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Malouf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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