Project UPLIFT to Reduce Anxiety and Depression in CF Patients

NCT03139266 | Completed DMC

• 2 other identifiers: HM20002923SCHECH15A0
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Anxiety; Depression

Keywords

cystic fibrosis; mindfulness; cognitive behavioral therapy; UPLIFT; anxiety; depression; web based intervention

Outcome Measures

Primary Outcomes (2)

• Reduce symptoms of anxiety among UPLIFT Tx Group participants.

  Anxiety symptoms will be assessed with the Generalized Anxiety Disorder-7 (GAD-7)

  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).

  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.

  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.

  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.

  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.

  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 (1)

• (Exploratory) Change in CF disease severity status.

  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)

Study Arms (2)

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.

Behavioral: UPLIFT

Control Group

OTHER

Treatment-as-usual

Behavioral: Treatment as usual

Interventions

UPLIFT 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.

UPLIFT

Treatment as usual BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of Michigan: collaborator
• Boston Children's Hospital: collaborator
• University at Buffalo: collaborator
• Emory University: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Johns Hopkins University: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Anxiety Disorders; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Michael S Schechter, MD, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 3, 2017
• Study Start: April 7, 2015
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)