Cystic FibrosisNCT03139266
Project UPLIFT to Reduce Anxiety and Depression in CF Patients
A study testing UPLIFT and Treatment as usual in people with Cystic Fibrosis and Anxiety, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cystic Fibrosis, Anxiety, Depression
- What is being tested?
- UPLIFT and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2015to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Persons reporting active suicidal ideation on the PHQ-9 will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Anxiety, Depression
- Being tested
- UPLIFT, Treatment as usual
- Keywords
- cystic fibrosis, mindfulness, cognitive behavioral therapy, UPLIFT, anxiety, depression, web based intervention
- Medical subject headings
- Cystic Fibrosis, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPLIFTBehavioural
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.
Treatment as usualBehavioural
The control group will receive the recommendation to consider maintaining mental health services
| Study group | Role | What they receive |
|---|---|---|
| UPLIFT | Experimental | 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. Receives: Behavioral: UPLIFT |
| Control Group | Other | Treatment-as-usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce symptoms of anxiety among UPLIFT Tx Group participants.
Anxiety symptoms will be assessed with the Generalized Anxiety Disorder-7 (GAD-7)
Measured: 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)
Reduce symptoms of depression among UPLIFT Tx Group participants.
Depressive Symptoms will be assessed with the Patient Health Questionnaire-9 (PHQ-9).
Measured: 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 (4)
Increase quality of life among UPLIFT Tx Group participants.
Quality of Life will be assessed using the Cystic Fibrosis Questionnaire-Revised (CFQ-R).
Measured: 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)
Increase satisfaction with life among UPLIFT Tx Group participants.
Satisfaction with life will be measured using the Satisfaction with Life Scale.
Measured: 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)
Improve knowledge and skills regarding self-management of anxiety and depression among UPLIFT Tx Group participants.
Will be assessed using an 18-item true-false measure developed during the development of Project UPLIFT.
Measured: 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)
Increase self-efficacy among UPLIFT Tx Group participants.
We will measure this using the Depression Coping Self-Efficacy Scale (DCSES).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start7 Apr 2015
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Michael S Schechter, MD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139266
- Sponsor's protocol ID
- HM20002923
- Other IDs
- SCHECH15A0
- Status last verified
- Jun 2023
- First submitted
- 24 Apr 2017
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project UPLIFT to Reduce Anxiety and Depression in CF Patients
- ClinicalTrials.gov ID
- NCT03139266
- Acronym / sponsor ID
- HM20002923
- Conditions
- Cystic Fibrosis, Anxiety, Depression
- Keywords
- cystic fibrosis, mindfulness, cognitive behavioral therapy, UPLIFT, anxiety, depression, web based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- 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
- Study start
- 7 Apr 2015 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UPLIFT | Experimental | Behavioral: UPLIFTThe 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. |
| Control Group | Other | Behavioral: Treatment as usualTreatment-as-usual |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- First, patients will have to agree to have their contact information shared with the study team in order to be eligible.
- 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
Key exclusion criteria (1 listed)
- Persons reporting active suicidal ideation on the PHQ-9 will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPLIFTParticipation 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. | Behavioural | UPLIFT |
| Treatment as usualThe control group will receive the recommendation to consider maintaining mental health services | Behavioural | Control Group |
Primary outcome
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)
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).
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Schechter, MD, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPLIFT and Treatment as usual in people with Cystic Fibrosis and Anxiety, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.