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Project UPLIFT to Reduce Anxiety and Depression in CF Patients

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ClinicalTrials.gov Identifier: NCT03139266
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : April 26, 2021
Sponsor:
Collaborators:
University of Michigan
Boston Children's Hospital
University at Buffalo
Emory University
Children's Hospital Medical Center, Cincinnati
Johns Hopkins University
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Anxiety Depression Behavioral: UPLIFT Behavioral: Treatment as usual Not Applicable

Detailed Description:

The Project UPLIFT intervention was designed for delivery to groups of six to eight people by telephone or Internet, though for this study the intervention will be web based only. The telephone intervention comprised eight hour-long sessions, each including check-in, instruction, skill building, and discussion, with homework between sessions. The Web intervention contains the same elements: check-in, video instruction, skill building, a discussion board, and homework between sessions. Instruction focuses on increasing knowledge about depression, CF, CBT, and mindfulness and skills related to CBT and mindfulness. 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. A week's homework is discussed at the beginning of the next session. The program is designed to guide participants from noticing, challenging, and changing thoughts (CBT components), to staying in the present moment with acceptance of and nonreactivity to those thoughts (mindfulness components). All sessions will be co-facilitated by a layperson with CF and a doctoral student in psychology, supervised by a licensed clinical psychologist.

Once the subjects are recruited and enrolled, baseline assessment will take place and then they will be randomized into the intervention group or treatment-as-usual control group condition (recommendation to consider obtaining mental health services). All participants will complete questionnaires via the internet. Following the initial assessment, the groups will receive their assigned intervention (or control treatment) and there will be questionnaire based testing of mental health, QoL, and disease management at 2 months (immediately following the group intervention), 6 months, and 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Project UPLIFT to Reduce Anxiety and Depression in CF Patients
Actual Study Start Date : April 7, 2015
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: UPLIFT
The Project UPLIFT intervention was designed for delivery to groups of six to eight people by telephone or Internet, though for this study the intervention will be web based only. The telephone intervention comprised eight hour-long sessions, each including check-in, instruction, skill building, and discussion, with homework between sessions. The Web intervention contains the same elements: check-in, video instruction, skill building, a discussion board, and homework between sessions. Instruction focuses on increasing knowledge about depression, cystic fibrosis (CF), cognitive behavioral therapy (CBT), and mindfulness and skills related to CBT and mindfulness.
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.

Control Group
Treatment-as-usual
Behavioral: Treatment as usual
The control group will receive the recommendation to consider maintaining mental health services




Primary Outcome Measures :
  1. Reduce symptoms of anxiety among UPLIFT Tx Group participants. [ Time Frame: Baseline (at 0 week), Tx End (at 8 weeks), Follow-up (at 6 months post Tx End), Extended Follow-up (at 12 months post Tx End) ]
    Anxiety symptoms will be assessed with the Generalized Anxiety Disorder-7 (GAD-7)

  2. Reduce symptoms of depression among UPLIFT Tx Group participants. [ Time Frame: Baseline (at 0 week), Tx End (at 8 weeks), Follow-up (at 6 months post Tx End), Extended Follow-up (at 12 months post Tx End) ]
    Depressive Symptoms will be assessed with the Patient Health Questionnaire-9 (PHQ-9).


Secondary Outcome Measures :
  1. Increase quality of life among UPLIFT Tx Group participants. [ Time Frame: Baseline (at 0 week), Tx End (at 8 weeks), Follow-up (at 6 months post Tx End), Extended Follow-up (at 12 months post Tx End) ]
    Quality of Life will be assessed using the Cystic Fibrosis Questionnaire-Revised (CFQ-R).

  2. Increase satisfaction with life among UPLIFT Tx Group participants. [ Time Frame: Baseline (at 0 week), Tx End (at 8 weeks), Follow-up (at 6 months post Tx End), Extended Follow-up (at 12 months post Tx End) ]
    Satisfaction with life will be measured using the Satisfaction with Life Scale.

  3. Improve knowledge and skills regarding self-management of anxiety and depression among UPLIFT Tx Group participants. [ Time Frame: Baseline (at 0 week), Tx End (at 8 weeks), Follow-up (at 6 months post Tx End), Extended Follow-up (at 12 months post Tx End) ]
    Will be assessed using an 18-item true-false measure developed during the development of Project UPLIFT.

  4. Increase self-efficacy among UPLIFT Tx Group participants. [ Time Frame: Baseline (at 0 week), Tx End (at 8 weeks), Follow-up (at 6 months post Tx End), Extended Follow-up (at 12 months post Tx End) ]
    We will measure this using the Depression Coping Self-Efficacy Scale (DCSES).


Other Outcome Measures:
  1. (Exploratory) Change in CF disease severity status. [ Time Frame: Baseline (at 0 week), Tx End (at 8 weeks), Follow-up (at 6 months post Tx End), Extended Follow-up (at 12 months post Tx End) ]
    CF disease related measures will be collected from routine clinic visits that occur from the time of enrollment to final UPLIFT follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

*Please note that only patients who are seen by one of our participating CF clinics (listed in "locations") will be approached about UPLIFT (if eligible) during this phase of the UPLIFT project.*

Inclusion Criteria:

First, patients will have to agree to have their contact information shared with the study team in order to be eligible.

Eligibility criteria:

  • have been diagnosed with CF for at least 1 year;
  • score 5-14 on the GAD-7 and/or a 5-19 on the PHQ-9;
  • be ≥13 years of age;
  • be English speaking; and
  • not have a prominent cognitive impairment.

Exclusion Criteria:

  • Persons reporting active suicidal ideation on the PHQ-9 will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139266


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
University of Michigan
Boston Children's Hospital
University at Buffalo
Emory University
Children's Hospital Medical Center, Cincinnati
Johns Hopkins University
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Michael S Schechter, MD, MPH Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03139266    
Other Study ID Numbers: HM20002923
SCHECH15A0 ( Other Grant/Funding Number: Cystic Fibrosis Foundation )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
cystic fibrosis
mindfulness
cognitive behavioral therapy
UPLIFT
anxiety
depression
web based intervention
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases