Anxiety, Pulmonary Fibrosis
Conditions
Brief summary
The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.
Detailed description
Patients will be randomised 1:1 to either receive treatment with the digital therapy, or to act as control group. Patients will be treated for 9 weeks, followed by a 3 week follow-up period. Efficacy will be assessed after 9 weeks.
Interventions
Therapy for patients with pulmonary fibrosis
Sponsors
Curebase Inc.
Vicore Pharma AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
HAM-A raters are blinded (HAM-A = Hamilton Anxiety Rating Scale).
Intervention model description
The investigation consisted of a Part 1 (pilot phase) with a single arm (4 weeks of dCBT), and a Part 2 (pivotal phase) with a randomised, controlled, parallel-group design to either 9 weeks of dCBT or a control group with no intervention.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥22 years at the time of signing the informed consent 2. Self-reported Pulmonary Fibrosis diagnosis 3. A GAD-7 score of ≥5 at pre-screening and baseline 4. If currently on prescribed medication for depression/anxiety, a stable dose for at least 4 weeks prior to baseline 5. CT scan report within 5 years prior to baseline with signs of PF (interstitial changes) 6. Capable of using a mobile device and common applications, and has an appropriate mobile or tablet device
Exclusion criteria
1. Self-reported manic disorders, psychotic disorders, schizophrenia, or alcohol/drug abuse during the past 6 months prior to baseline (Visit 1), as judged by the investigator or designee. 2. Self-reported history of hospital admissions due to suicidal behavior or attempts, as judged by the investigator or designee 3. Self-reported previous or current diagnosis of major depressive disorder, as judged by the investigator or designee 4. Verbal and/or written communication problems limiting ability to engage with dCBT-IPF 5. Inability to comply with investigation procedures, due to e.g. cognitive impairment or severe medical conditions as judged by the investigator or designee 6. Currently receiving cognitive behavioral therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 | Baseline to Week 4 | Subject feedback on functionality and experience of the dCBT-PF at Week 4 collected through subject interviews following a separate semi-structured interview guide. |
| Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9. | Baseline to Week 9 | The questionnaire includes 7 questions. Each question will be scored on a 4-point scale from 0 to 3 points. Higher score will mean a worse outcome. The GAD-7 represents an anxiety measure based on seven items which are scored from zero to three (0=Not at all,1=Several days, 2=More than half the days and 3=Nearly every day). The composite score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 - Safety of dCBT-PF-in Patients With IPF | Baseline to week 4 | Information on AEs, ADEs, SAEs, SADE and device deficiencies which could lead to an ADE or SADE was collected at visits at week 2 and week 4. |
| Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9 | 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 (not present) to 4 (very severe) will be summed up to give a total possible score of 0 to 56, where lower scores indicate less anxiety. |
| Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9. | Baseline to Week 9 | The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status. |
| Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9. | Baseline to Week 9 | The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status. |
Countries
United States
Participant flow
Recruitment details
11 subjects were enrolled in the pilot phase (Part 1) to receive 4 weeks of dCBT. 108 subjects were enrolled in the pivotal phase (Part 2) to recieve either 9 weeks of dCBT or no intervention.
Pre-assignment details
This investigation consisted of two parts: Part 1 - A pilot phase with the key purpose of testing the functionality of dCBT-PF. Part 2 - A pivotal phase with the key purpose of evaluating the efficacy of dCBT-PF versus a control on patient-reported psychological symptom burden in patients with PF.
Participants by arm
| Arm | Count |
|---|---|
| Part 2 - Digital Cognitive Behavioral Therapy Part 2: 9 weeks digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis | 54 |
| Part 2 - Control Group No intervention | 54 |
| Part 1 - Digital Cognitive Behavioral Therapy Part 1: 4 weeks digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis | 11 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Pilot Investigation - Part 1 | Withdrawal by Subject | 0 | 0 | 1 |
| Pivotal Investigation - Part 2 | Death | 1 | 4 | 0 |
| Pivotal Investigation - Part 2 | Lost to Follow-up | 2 | 2 | 0 |
| Pivotal Investigation - Part 2 | Withdrawal by Subject | 5 | 2 | 0 |
Baseline characteristics
| Characteristic | Part 2 - Digital Cognitive Behavioral Therapy | Part 2 - Control Group | Part 1 - Digital Cognitive Behavioral Therapy | Total |
|---|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 10.21 | 68.9 years STANDARD_DEVIATION 8.12 | 71.1 years STANDARD_DEVIATION 9.38 | 67.5 years STANDARD_DEVIATION 9.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 51 Participants | 11 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 50 Participants | 11 Participants | 110 Participants |
| Sex: Female, Male Female | 38 Participants | 33 Participants | 5 Participants | 76 Participants |
| Sex: Female, Male Male | 16 Participants | 21 Participants | 6 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 53 | 4 / 54 | 0 / 10 |
| other Total, other adverse events | 3 / 53 | 4 / 54 | 1 / 10 |
| serious Total, serious adverse events | 5 / 53 | 9 / 54 | 0 / 10 |
Outcome results
Primary
Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4
Subject feedback on functionality and experience of the dCBT-PF at Week 4 collected through subject interviews following a separate semi-structured interview guide.
Time frame: Baseline to Week 4
Population: Qualitative information on functionality and experience was collected from 10 participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 | The device was intuitive and easy to use | 8 Participants |
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 | Feature allowing users to review entries in the tool to be added to the device | 2 Participants |
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 | Account setting page for users to be added to the device (e.g. for resetting password) | 2 Participants |
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 | Difficulties in following the audio tool guidance | 1 Participants |
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 1 - Subject Feedback on Functionality and Experience of the dCBT-PF at Week 4 | Notifications for daily prompts for device usage to be added | 3 Participants |
Primary
Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9.
The questionnaire includes 7 questions. Each question will be scored on a 4-point scale from 0 to 3 points. Higher score will mean a worse outcome. The GAD-7 represents an anxiety measure based on seven items which are scored from zero to three (0=Not at all,1=Several days, 2=More than half the days and 3=Nearly every day). The composite score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.
Time frame: Baseline to Week 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9. | -1.8 score on a scale |
| Control Group | Part 2 - Change From Baseline in Anxiety Symptom Severity Assessed by Generalized Anxiety Disorder 7-item (GAD-7) at Week 9. | 0.9 score on a scale |
Secondary
Part 1 - Safety of dCBT-PF-in Patients With IPF
Information on AEs, ADEs, SAEs, SADE and device deficiencies which could lead to an ADE or SADE was collected at visits at week 2 and week 4.
Time frame: Baseline to week 4
Population: 1 AE was reported in the pilot phase of the investigation. AE information was not collected for the subject who did not initiate treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 1 - Safety of dCBT-PF-in Patients With IPF | 1 Adverse event |
Secondary
Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at 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 (not present) to 4 (very severe) will be summed up to give a total possible score of 0 to 56, where lower scores indicate less anxiety.
Time frame: Baseline to Week 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9 | -6.7 score on a scale |
| Control Group | Part 2 - Change From Baseline in Anxiety Symptom Severity as Assessed by Hamilton Anxiety Rating Scale (HAM-A) at Week 9 | -4.7 score on a scale |
Secondary
Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9.
The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.
Time frame: Baseline to Week 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9. | 8.1 score on a scale |
| Control Group | Part 2 - Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Psychological Domain Score at Week 9. | 1.6 score on a scale |
Secondary
Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9.
The questionnaire includes 3 domains (breathlessness and activities, chest symptoms and psychological). The K-BILD domain and total scores ranges are 0-100; 100 represents the best health status.
Time frame: Baseline to Week 9
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Part 1: 4 Weeks Digital Cognitive Behavioral Therapy. | Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9. | 4.8 score on a scale |
| Control Group | Part 2- Change From Baseline in HRQoL Assessed by King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 9. | 0.4 score on a scale |