Project UPLIFT to Reduce Anxiety and Depression in CF Patients

NCT ID: NCT03139266

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-07
• Study Completion Date: 2022-08-02

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.

Conditions

Cystic Fibrosis; Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

UPLIFT

Intervention Type: BEHAVIORAL

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

Group Type: OTHER

Treatment as usual

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as usual

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael S Schechter, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form: Parental consent

View Document

Document Type: Informed Consent Form: Adult consent

View Document

Other Identifiers

SCHECH15A0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20002923

Identifier Type: -

Identifier Source: org_study_id