Flowy randomized controlled pilot trial

Not Applicable

Completed

• Conditions: Anxiety disorders; Mental and Behavioural Disorders

• Registration Number: ISRCTN78356215
• Lead Sponsor: Queen Mary University of London

Brief Summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26536488

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-07-11
• Study Start: 2015-03-30
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age at least 18 years old
2. Screen GAD-7 score =6
3. Screen OASIS score =8
4. Screen ASI-3 score =16
5. Comorbid disorders including major depression, dysthymia, panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, simple phobia, obsessive compulsive disorder, and somatization disorder with moderate symptoms of anxiety
6. Concurrent use of antidepressants, anxiolytics, hypnotics, and herbal products with psychoactive substances acceptable provided there is no change in medication type and dose after randomization
7. Provision of written informed consent
8. Able to comply with the study protocol (e.g., able to download Flowy onto mobile device or able to complete assessments)

Exclusion Criteria

1. Lack of mobile device or incompatible operating system (Android and iOS compatibility required)
2. Lack of access to Internet
3. Any co-existing medical conditions that could alter the clinical presentation of hyperventilation such as chronic severe asthma or chronic obstructive pulmonary disease
4. Lifetime history of bipolar disorder or psychosis
5. Presence of any Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Axis I disorder, excluding those listed in the inclusion criteria, that are likely to interfere with the patient’s ability to participate in the study, as judged by the investigator
6. Presence of any DSM-IV Axis II disorder that are likely to interfere with the patient’s ability to participate in the study, as judged by the investigator
7. Participants who are acutely suicidal to the degree that precautions against suicide are needed or have a history of suicide attempt in the past 5 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified