Controlled Investigation to Evaluate Impact of dCBT on Psychological Symptom Burden in Adult Subjects With PF

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-17

Study Completion Date

2023-11-10

Brief Summary

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The purpose of the study is to assess efficacy and safety of a digital cognitive behavioural therapy for patients with pulmonary fibrosis on anxiety.

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Detailed Description

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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.

Conditions

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Pulmonary Fibrosis Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

HAM-A raters are blinded (HAM-A = Hamilton Anxiety Rating Scale).

Study Groups

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Part 1 - Digital cognitive behavioral therapy

4 weeks digital cognitive behavioral therapy.

Group Type EXPERIMENTAL

Digital cognitive behavioral therapy

Intervention Type DEVICE

Therapy for patients with pulmonary fibrosis

Part 2 - Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Part 2 - Digital cognitive behavioral therapy

9 weeks digital cognitive behavioral therapy

Group Type EXPERIMENTAL

Digital cognitive behavioral therapy

Intervention Type DEVICE

Therapy for patients with pulmonary fibrosis

Interventions

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Digital cognitive behavioral therapy

Therapy for patients with pulmonary fibrosis

Intervention Type DEVICE

Other Intervention Names

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dCBT-PF

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No