Digital cognitive behavioural therapy for anxiety

Not Applicable

Completed

• Conditions: Generalised anxiety disorder; Mental and Behavioural Disorders; Generalized anxiety disorder

• Registration Number: ISRCTN12765810
• Lead Sponsor: niversity of Oxford

Brief Summary

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32326980 (added 27/04/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32950939/ (added 19/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-11
• Study Completion: 2020-06-01
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Current participant inclusion criteria as of 18/09/2019:
1. Aged 18+ years.
2. A score of 10 or higher on the Generalised Anxiety Disorder questionnaire (GAD-7) indicating at least moderate GAD symptom severity.
3. Screen positive for a GAD diagnosis on a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM-5.
4. Must be either not on psychotropic medication or on a stable dose for at least 4 weeks.
5. Must not be currently receiving or have previously received CBT for anxiety in the last 12 months.

Previous participant inclusion criteria:
1. Aged 18+ years
2. A score of 10 or higher on the Generalised Anxiety Disorder questionnaire (GAD-7) indicating at least moderate GAD symptom severity
3. Screen positive for a GAD diagnosis on a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM-5
4. Must be either not on psychotropic medication or on a stable dose for at least 4 weeks

Exclusion Criteria

1. Past or present seizure disorder or a clinically significant head trauma (e.g. brain damage)
2. Substance use disorder
3. Serious physical health concerns necessitating surgery or with prognosis < 6 months
4. Current bipolar disorder, psychosis, or schizophrenia
5. Severe cognitive impairment that does not allow participants to consent or follow treatment instructions
6. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 08/08/2019:<br> Severity of anxiety symptoms will be measured using the 7-item Generalised Anxiety Disorder questionnaire (GAD-7) (Spitzer et al., 2006) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation; primary endpoint), and follow-up (10 weeks from randomisation).<br><br> Previous primary outcome measure:<br> Severity of anxiety symptoms will be measured using the 7-item Generalised Anxiety Disorder questionnaire (GAD-7) (Spitzer et al., 2006) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation; primary endpoint), and follow-up (18 weeks from randomisation).<br>