Clinical trial NCT03139266: Project UPLIFT to Reduce Anxiety and Depression in CF Patients
Official title: Project UPLIFT to Reduce Anxiety and Depression in CF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Anxiety
Depression
Keywords: cystic fibrosis
mindfulness
cognitive behavioral therapy
UPLIFT
anxiety
depression
web based intervention
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Boston Children's Hospital
name: University at Buffalo
name: Emory University
name: Children's Hospital Medical Center, Cincinnati
name: Johns Hopkins University
name: Cystic Fibrosis Foundation
First posted: 2017-05-03
Enrollment: 85
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Reduce symptoms of anxiety among UPLIFT Tx Group participants.
timeFrame: 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)
measure: Reduce symptoms of depression among UPLIFT Tx Group participants.
timeFrame: 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)
Secondary outcomes:
measure: Increase quality of life among UPLIFT Tx Group participants.
timeFrame: 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)
measure: Increase satisfaction with life among UPLIFT Tx Group participants.
timeFrame: 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)
measure: Improve knowledge and skills regarding self-management of anxiety and depression among UPLIFT Tx Group participants.
timeFrame: 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)
measure: Increase self-efficacy among UPLIFT Tx Group participants.
timeFrame: 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)
Other outcomes:
measure: (Exploratory) Change in CF disease severity status.
timeFrame: 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)
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Michael S Schechter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: