Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF (COMPANION)
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|ClinicalTrials.gov Identifier: NCT05330312|
Recruitment Status : Recruiting
First Posted : April 15, 2022
Last Update Posted : December 14, 2022
The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.
The study is decentralized and participation is not limited to patients living close to the sites.
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder Pulmonary Fibrosis||Device: Digital cognitive behavioral therapy||Not Applicable|
The study consist of two parts (part 1 and part 2). Prior to treatment with the digital therapy all patients will sign an informed consent form and eligibility will be checked.
In part 1 eligible patients will be treated for 4 weeks with the treatment. The main purpose of part 1 is to evaluate the functionality of the digital therapy.
In part 2 patients will be randomised 1:1 to either receive treatment with the digital therapy, or to act as control group. Note: The control group will be offered access to the digital therapy, under an Exclusive Release of the product, following completion of the Week 12 visit of the investigation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled, Parallel-group Clinical Investigation Evaluating the Impact of Digital Cognitive Behavioural Therapy on Psychological Symptom Burden in Adults Diagnosed With Pulmonary Fibrosis|
|Actual Study Start Date :||April 17, 2022|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: Digital cognitive behavioral therapy
Part 1: 4 weeks digital cognitive behavioral therapy. Part 2: 9 weeks digital cognitive behavioral therapy.
Device: Digital cognitive behavioral therapy
Therapy for patients with pulmonary fibrosis
Other Name: dCBT-PF
No Intervention: Control group
Note: Access to dCBT-PF for the control group will be provided under an Exclusive Release of the product, following completion of the Week 12 visit in the investigation.
- Part 1: Qualitative patient satisfaction with functionality of dCBT-IPF based on a semi-structured interview [ Time Frame: Week 4 ]Based on a patient interview. No scale will be used and the evaluation will be based on the patient's verbally reported satisfaction with dCBT-IPF.
- Part 2: Change in anxiety symptom severity assessed by generalized anxiety disorder 7-item (GAD-7) [ Time Frame: Baseline to Week 9 ]The questionnaire includes 7 questions. Each question will be scored on a 4-point likert scale from 0 to 3 points. Higher score will mean a worse outcome.
- Part 2: Change in anxiety symptom severity assessed by Hamilton anxiety rating scale (HAM-A) [ Time Frame: Baseline to Week 9 ]The questionnaire includes 14 questions rating the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 to 4. The HAM-A total score range from 0 to 56, where a lower scores indicate less anxiety.
- Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological domain score [ Time Frame: Baseline to Week 9 ]The questionnaire includes 15 questions. Each question will be scored on a scale from 1 to 7. The K-BILD total score range will be from 0 to 100 points. Higher score will mean a worse outcome.
- Part 2: Change in health-related quality of life (HRQoL) assessed by King's brief interstitial lung disease (K-BILD) psychological total score [ Time Frame: Baseline to Week 9 ]The questionnaire includes 15 questions. Each question will be scored on a scale from 1 to 7. The K-BILD total score range will be from 0 to 100 points. Higher score will mean a worse outcome.
- Part 1 and 2: Frequency of adverse events during treatment with dCBT-PF versus control [ Time Frame: Week 4 (Part 1) and Week 9 (Part 2) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05330312
|Contact: Anne Katrine Cohrt||+46(0)email@example.com|
|Contact: Cecilia Ganslandt, M.D.||+46(0)firstname.lastname@example.org|
|United States, California|
|Curebase Study Site||Recruiting|
|San Francisco, California, United States, 94118|
|Contact: Study Coordinators 628-261-6287 email@example.com|
|United States, Utah|
|University of Utah Health||Not yet recruiting|
|Salt Lake City, Utah, United States, 84025|
|Contact: Lindsey Waddoups, MS 801-581-5811 firstname.lastname@example.org|
|Contact: Macy Barrios 801-581-5811 email@example.com|
|Principal Investigator:||Maureen Horton, MD||Curebase study site|