Generalised anxiety disorder Mental and Behavioural Disorders Generalized anxiety disorder
Conditions
Interventions
Current interventions as of 26/08/2021:
In this study, participants will be randomised into one of two groups. Group 1 will receive digital CBT and group 2 will receive psychoeducation. Outcomes are a
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged =18 years old 2. Score =10 on the 7-item Generalized Anxiety Disorder scale (GAD-7) 3. Screen positive for GAD diagnosis against Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and phone call verification of diagnosis using a modified version of the Structured Clinical Interview for DSM-5 (SCID) 4. Either not on psychotropic medication or on a stable dose for at least 4 weeks before screening assessment 5. Oral and written fluency in English 6. Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the approved informed consent form
Exclusion criteria
Exclusion criteria: 1. Currently receiving or be expecting to start CBT for anxiety during study participation, or have previously received CBT for anxiety in the past 12-months (self-report) 2. Self-reported diagnosis of schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder; recent trauma to the head or brain damage; recent inpatient psychiatric admission or crisis team support 3. Cognitive impairment that does not allow participants to consent or follow treatment instructions (self-report) 4. Physical health concerns necessitating surgery or with <6 months to live (self-report) 5. Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 16/08/2022: Generalized anxiety disorder symptoms measured using the General Anxiety Disorder-7 (GAD-7) at baseline, mid-intervention (6 weeks from randomisation), post-intervention (10 weeks from randomisation) and follow-up (18 weeks from randomisation). A further uncontrolled evaluation will take place 1 year from randomisation. _____ Previous primary outcome measure as of 26/08/2021: Generalized anxiety disorder symptoms measured using the General Anxiety Disorder-7 (GAD-7) at baseline, mid-intervention (6 weeks from randomisation), post-intervention (10 weeks from randomisation) and follow-up (18 weeks from randomisation) _____ Previous primary outcome measure: Generalized anxiety disorder symptoms measured using the General Anxiety Disorder-7 (GAD-7) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation) and follow-up (18 weeks from randomisation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/08/2022: 1. Assessor-rated anxiety assessed using the Hamilton Anxiety Rating Scale (HAM-A) at baseline, post-intervention (10 weeks from randomisation) and follow-up (18 weeks from randomisation) 2. Social anxiety symptoms measured using the self-report Mini Social Phobia Inventory (Mini-SPIN) at baseline, mid-intervention (6 weeks from randomisation), post-intervention (10 weeks from randomisation) and follow-up (18 weeks from randomisation). A further uncontrolled evaluation will take place 1 year from randomisation. 3. Panic disorder symptoms measured using the self-report Panic Disorder Severity Scale at baseline, mid-intervention (6 weeks from randomisation), post-intervention (10 weeks from randomisation) and follow-up (18 weeks from randomisation). A further uncontrolled evaluation will take place 1 year from randomisation. 4. Post-traumatic stress disorder (PTSD) symptoms measured by the 8-item version of the PTSD Checklist for DSM-5 (PCL-5) at baseline, mid-intervention (6 weeks from randomisation), post-intervention (10 weeks from randomisation) and follow-up (18 weeks from randomisation). A further uncontrolled evaluation will take place 1 year from randomisation. 5. Obsessive-compulsive disorder symptoms measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) at baseline, mid-intervention (6 weeks from randomisation), post-intervention (10 weeks from randomisation) and follow-up (18 weeks from randomisation). A further uncontrolled evaluation will take place 1 year from randomisation. 6. Worry measured using the Penn State Worry Questionnaire (PSWQ) at baseline, mid-intervention (6 weeks from randomisation), post-intervention (10 weeks from randomisation) and follow-up (18 weeks from randomisation). A further uncontrolled evaluation will take place 1 year from randomisation. 7. Depressive symptoms measured using the Patient Health Questionnaire (PHQ-8) at baseline, mid-intervention (6 weeks from randomis | — |
Countries
England, United Kingdom, United States of America
Contacts
Public ContactAlasdair Henry
Outcome results
None listed