Project UPLIFT to Reduce Anxiety and Depression in CF Patients



Status:Recruiting
Conditions:Anxiety, Depression, Depression, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:13 - Any
Updated:2/27/2019
Start Date:April 7, 2015
End Date:May 1, 2019
Contact:Andrea Molzhon, PhD
Email:molzhonar@vcu.edu
Phone:804-628-4967

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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.

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 adherence at 2 months (immediately
following the group intervention), 6 months, and 12 months.

*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.
We found this trial at
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Richmond, Virginia 23298
(804) 828-0100
Phone: 804-628-4967
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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