Project UPLIFT to Reduce Anxiety and Depression in CF Patients

NCT03139266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-06-06

No results posted yet for this study

Summary

People with CF have elevated rates of anxiety and depression when compared to the general population. Anxiety and depression can have a negative impact on adherence and disease self-management, leading to worse CF health outcomes such as respiratory symptoms, functional capacity, and health-related quality of life (HRQOL).

Project UPLIFT is a group mental health intervention that can be delivered by telephone or Web, though for this study the intervention will be web based only. Project UPLIFT was originally developed as a depression treatment and prevention program for people with epilepsy and was shown to be effective in reducing depression and increasing knowledge and skills. Recently, Project UPLIFT was revised to help people with CF manage their depression and anxiety and shown to be apparently successful in a pilot study that included adolescents and adults with CF.

The goals of this project are to determine the effectiveness of Project UPLIFT in reducing anxiety and depression in adolescents and adults with CF, as well as increasing their quality of life and other physical health-related disease outcomes.

Conditions

Interventions

BEHAVIORAL

UPLIFT

Participation in the sessions involves skills practice, discussions, and group exercises based on the sessions' main topics. CBT-related topics include thought monitoring, identifying cognitive distortions, self-esteem, problem identification, goal setting, and identifying supports. Relaxation exercises, including a body scan (i.e., a mindfulness exercise) and progressive muscle relaxation, are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to skin, sights, and sounds and other meditations. Participants will practice their skills between sessions through homework assignments including monitoring and changing thoughts, and practicing relaxation exercises, meditation exercises, and mindfulness.

BEHAVIORAL

Treatment as usual

The control group will receive the recommendation to consider maintaining mental health services

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER
  • Boston Children's Hospital

    collaborator OTHER
  • University at Buffalo

    collaborator OTHER
  • Emory University

    collaborator OTHER
  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER
  • Johns Hopkins University

    collaborator OTHER
  • Cystic Fibrosis Foundation

    collaborator OTHER
  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Michael S Schechter, MD, MPH · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-07
Primary Completion
2022-08-02
Completion
2022-08-02

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03139266 on ClinicalTrials.gov