A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
CBT
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With T1DM
2 other identifiers
interventional
51
1 country
1
Brief Summary
All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life. Fear of hypoglycemia results in glucose fluctuations (from high to low glucose levels). Young adults are particularly at risk because they report high levels of fear of hypoglycemia and poor glucose control. Currently, no diabetes self-management programs specifically address how to cope with fear of hypoglycemia. The investigators propose to pilot test a fear reduction intervention (Fear Reduction Efficacy Evaluation \[FREE\]) and its effects on fear of hypoglycemia, diabetes self-management, glucose control, and glucose variability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 7, 2018
CompletedStudy Start
First participant enrolled
January 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
May 20, 2022
CompletedJune 6, 2024
March 1, 2024
2.5 years
April 24, 2018
October 25, 2021
May 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fear of Hypoglycemia
Change in Worry Subscale score. Fear of hypoglycemia is measured with the Worry Subscale of the Hypoglycemia Fear Survey II (HFS-II) which is an 18-item, 5-point Likert-style scale with a possible score range from 0-72. A higher score indicates greater fear of hypoglycemia.
Assessing change between two time points: from baseline to week 8 of intervention.
Secondary Outcomes (2)
Glycemic Control
Assessing change between two time points: from baseline to week 8 of intervention.
Glycemic Variability
Assessing change between two time points: from baseline to week 8 of intervention
Study Arms (2)
Fear Reduction Efficacy Evaluation (FREE)
EXPERIMENTALThe FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.
Attention Control
ACTIVE COMPARATORThe attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of T1DM ≥ 1 year, receive medical care from an endocrinologist, use insulin pump therapy or multiple daily injection (MDI), have fear of hypoglycemia (screening questionnaire), and attended a basic diabetes educational program
You may not qualify if:
- Pregnant or breastfeeding, have received therapy specifically for fear of hypoglycemia, have a co-existing chronic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Related Publications (2)
Martyn-Nemeth P, Duffecy J, Quinn L, Park C, Reutrakul S, Mihailescu D, Park M, Penckofer S. FREE: A randomized controlled feasibility trial of a cognitive behavioral therapy and technology-assisted intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes. J Psychosom Res. 2024 Jun;181:111679. doi: 10.1016/j.jpsychores.2024.111679. Epub 2024 Apr 20.
PMID: 38677235DERIVEDMartyn-Nemeth P, Duffecy J, Quinn L, Park C, Mihailescu D, Penckofer S. A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial. Trials. 2019 Dec 30;20(1):796. doi: 10.1186/s13063-019-3876-4.
PMID: 31888691DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Martyn-Nemeth
- Organization
- University of Illinois at Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Martyn-Nemeth, PhD
University of Illinois at Chic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Principal Investigator and outcome assessors masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor Biobehavioral Nursing Science College of Nursing
Study Record Dates
First Submitted
April 24, 2018
First Posted
June 7, 2018
Study Start
January 14, 2019
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
June 6, 2024
Results First Posted
May 20, 2022
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share