Trial Outcomes & Findings for Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF (NCT NCT05330312)
NCT ID: NCT05330312
Last Updated: 2024-09-24
Results Overview
Subject feedback on functionality and experience of the dCBT-PF at Week 4 collected through subject interviews following a separate semi-structured interview guide.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2024-09-24
Participant Flow
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.
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.
Participant milestones
| Measure |
Part 2 - Digital Cognitive Behavioral Therapy
9 weeks of digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
Part 2 - Control Group
No intervention
|
Part 1 - Digital Cognitive Behavioral Therapy
4 weeks of digital cognitive behavioral therapy
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
|---|---|---|---|
|
Pilot Investigation - Part 1
STARTED
|
0
|
0
|
11
|
|
Pilot Investigation - Part 1
COMPLETED
|
0
|
0
|
10
|
|
Pilot Investigation - Part 1
NOT COMPLETED
|
0
|
0
|
1
|
|
Pivotal Investigation - Part 2
STARTED
|
54
|
54
|
0
|
|
Pivotal Investigation - Part 2
COMPLETED
|
46
|
46
|
0
|
|
Pivotal Investigation - Part 2
NOT COMPLETED
|
8
|
8
|
0
|
Reasons for withdrawal
| Measure |
Part 2 - Digital Cognitive Behavioral Therapy
9 weeks of digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
Part 2 - Control Group
No intervention
|
Part 1 - Digital Cognitive Behavioral Therapy
4 weeks of digital cognitive behavioral therapy
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
|---|---|---|---|
|
Pilot Investigation - Part 1
Withdrawal by Subject
|
0
|
0
|
1
|
|
Pivotal Investigation - Part 2
Lost to Follow-up
|
2
|
2
|
0
|
|
Pivotal Investigation - Part 2
Withdrawal by Subject
|
5
|
2
|
0
|
|
Pivotal Investigation - Part 2
Death
|
1
|
4
|
0
|
Baseline Characteristics
Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF
Baseline characteristics by cohort
| Measure |
Part 2 - Digital Cognitive Behavioral Therapy
n=54 Participants
Part 2: 9 weeks digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
Part 2 - Control Group
n=54 Participants
No intervention
|
Part 1 - Digital Cognitive Behavioral Therapy
n=11 Participants
Part 1: 4 weeks digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 10.21 • n=93 Participants
|
68.9 years
STANDARD_DEVIATION 8.12 • n=4 Participants
|
71.1 years
STANDARD_DEVIATION 9.38 • n=27 Participants
|
67.5 years
STANDARD_DEVIATION 9.28 • n=483 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
76 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
114 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
110 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Qualitative information on functionality and experience was collected from 10 participants.
Subject feedback on functionality and experience of the dCBT-PF at Week 4 collected through subject interviews following a separate semi-structured interview guide.
Outcome measures
| Measure |
Part 1: 4 Weeks Digital Cognitive Behavioral Therapy.
n=10 Participants
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis.
|
Control Group
No intervention
|
|---|---|---|
|
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 - 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
|
—
|
|
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 - 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 - 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
|
—
|
PRIMARY outcome
Timeframe: Baseline to Week 9The 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.
Outcome measures
| Measure |
Part 1: 4 Weeks Digital Cognitive Behavioral Therapy.
n=54 Participants
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis.
|
Control Group
n=54 Participants
No intervention
|
|---|---|---|
|
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
Interval -5.9 to 2.4
|
0.9 score on a scale
Interval -3.3 to 5.1
|
SECONDARY outcome
Timeframe: Baseline to week 4Population: 1 AE was reported in the pilot phase of the investigation. AE information was not collected for the subject who did not initiate treatment.
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.
Outcome measures
| Measure |
Part 1: 4 Weeks Digital Cognitive Behavioral Therapy.
n=10 Participants
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis.
|
Control Group
No intervention
|
|---|---|---|
|
Part 1 - Safety of dCBT-PF-in Patients With IPF
|
1 Adverse event
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 9The 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.
Outcome measures
| Measure |
Part 1: 4 Weeks Digital Cognitive Behavioral Therapy.
n=54 Participants
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis.
|
Control Group
n=54 Participants
No intervention
|
|---|---|---|
|
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
Interval -8.7 to -4.7
|
-4.7 score on a scale
Interval -6.5 to -2.8
|
SECONDARY outcome
Timeframe: Baseline to Week 9The 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.
Outcome measures
| Measure |
Part 1: 4 Weeks Digital Cognitive Behavioral Therapy.
n=54 Participants
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis.
|
Control Group
n=54 Participants
No intervention
|
|---|---|---|
|
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
Interval 4.3 to 11.9
|
1.6 score on a scale
Interval -1.9 to 5.1
|
SECONDARY outcome
Timeframe: Baseline to Week 9The 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.
Outcome measures
| Measure |
Part 1: 4 Weeks Digital Cognitive Behavioral Therapy.
n=54 Participants
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis.
|
Control Group
n=54 Participants
No intervention
|
|---|---|---|
|
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
Interval 2.3 to 7.3
|
0.4 score on a scale
Interval -2.0 to 2.9
|
Adverse Events
Part 2 - Digital Cognitive Behavioral Therapy
Serious events: 5 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 2 - Control Group
Serious events: 9 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 1 - Digital Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 2 - Digital Cognitive Behavioral Therapy
n=53 participants at risk
9 weeks digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
Part 2 - Control Group
n=54 participants at risk
No intervention
|
Part 1 - Digital Cognitive Behavioral Therapy
n=10 participants at risk
4 weeks digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
1.9%
1/53 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/54 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
General disorders
Chest Pain
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
General disorders
Death
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
3.7%
2/54 • Number of events 2 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Investigations
Oxygen saturation decreased
|
1.9%
1/53 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/54 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Renal and urinary disorders
Urosepsis
|
1.9%
1/53 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/54 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.9%
1/53 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/54 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
1.9%
1/53 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
1.9%
1/54 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
Other adverse events
| Measure |
Part 2 - Digital Cognitive Behavioral Therapy
n=53 participants at risk
9 weeks digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
Part 2 - Control Group
n=54 participants at risk
No intervention
|
Part 1 - Digital Cognitive Behavioral Therapy
n=10 participants at risk
4 weeks digital cognitive behavioral therapy.
Digital cognitive behavioral therapy: Therapy for patients with pulmonary fibrosis
|
|---|---|---|---|
|
General disorders
Fatigue
|
1.9%
1/53 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/54 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/53 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
7.4%
4/54 • Number of events 4 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Psychiatric disorders
Depression
|
1.9%
1/53 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
3.7%
2/54 • Number of events 2 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/10 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/53 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
0.00%
0/54 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
10.0%
1/10 • Number of events 1 • Part 1 - Adverse events/adverse device effects were collected from week 2 until week 4. Subjects were asked at week 2 and 4 if any AE or ADE had been experienced since last visit. AE information was not collected for the subject who did not initiate treatment. Part 2 - Adverse events/adverse device effects were collected from week 3 until week 12. Subjects were asked at week 3, 6, 9 and 12 if any AE or ADE had been experienced since last visit.
In this study, selective AE collection was conducted. All ADE, SAE, or SADE are reported, regardless of treatment-relation. For non-serious, non-treatment-related AEs, only events that were associated with a psychological disorder or with a procedure of the clinical investigation were collected in accordance with the clinical investigation plan and are reported.1 subject in the dCBT-PF arm of Part 2 was randomised but unable to start treatment. AE information was not collected for this subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The primary publication should be published by the sponsor prior to any other investigator-initiated publications, manuscripts, abstracts, or presentations. The results of this clinical investigation may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER