Back to resultsExamining the Effectiveness of Wysa for Worry Program
Primary Purpose
Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wysa for Worry
App-based Psychoeducation
Sponsored by
About this trial
This is an interventional other trial for Anxiety focused on measuring Worry, Anxiety, Digital Mental Health
Eligibility Criteria
Inclusion Criteria: The inclusion criteria for the study is as follows: Patients who are at least 18 years of age. Patients who have mild to moderate symptoms of anxiety (scores: 5-15, according to GAD-7). Patients who are not already engaged in psychological therapy and not intending to start psychological therapy in the next eight weeks. Patients who haven't used any DMHI (Digital Mental Health Interventions) in the last 6 months. Patients without risk of suicidal ideation and behaviour. Patients who are capable of reading and understanding English and have provided written or verbal informed consent to participate. Patients who own and use a smartphone with functional audio. Exclusion Criteria: Patients who are at an increased risk of suicide. Patients with diagnosis of or receiving treatment for alcohol/substance use disorder. Patients who've had their psychiatric medication or dose changed in the last 1 month. Patients who suffer from severe anxiety Patients with diagnosis of or receiving treatment for an active state of psychosis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active Intervention
Control arm
Arm Description
Outcomes
Primary Outcome Measures
Change in scores of Generalized Anxiety Disorder Scale (GAD-7)
GAD-7 is a 7 item assessment that screens for anxiety and assesses the severity of anxiety symptoms.
Secondary Outcome Measures
Change in scores of Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 is a 9 item assessment that screens for depressive symptoms and assesses the severity of the depressive symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05943418
Brief Title
Examining the Effectiveness of Wysa for Worry Program
Official Title
Examining the Effectiveness of Wysa's Computerized Cognitive Behavioral Therapy Program (a Digital Mental Health Intervention) in Reducing Symptoms of Anxiety: Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wysa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this randomized controlled trial is to test for the effectiveness of Wysa's Worry computerized cognitive behaviour therapy (cCBT) program (a digital mental health intervention) in comparison to a digital app that offers psychoeducation to patients who have mild to moderate symptoms of anxiety.
Detailed Description
People dealing with worry can receive augmented support from digital mental health interventions. The intervention being tested in this study is Wysa's Worry cCBT program. Its outcomes will be compared to a randomized, controlled arm that offers psychoeducation.
For the purpose of this study participants will be recruited through different online channels and will be randomly assigned to either the intervention or control group. Regardless of their assignment they will be completing weekly standardized assessments examining their symptoms of anxiety and depression, and examining any improvement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Worry, Anxiety, Digital Mental Health
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial with an intervention arm and a control arm.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Intervention
Arm Type
Experimental
Arm Title
Control arm
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Wysa for Worry
Intervention Description
The Wysa for Worry cCBT program is a week-based cCBT programme consisting of specialised cognitive behavior therapy (CBT) interventions delivered through a conversational agent.
Each week of the programme focuses on a different CBT technique or intervention, which is explained in a short weekly video. Following each video, the technique or intervention is discussed and practiced with Wysa's AI chatbot.
Intervention Type
Behavioral
Intervention Name(s)
App-based Psychoeducation
Intervention Description
The control will include the weekly delivery of active psychoeducational resources.
Primary Outcome Measure Information:
Title
Change in scores of Generalized Anxiety Disorder Scale (GAD-7)
Description
GAD-7 is a 7 item assessment that screens for anxiety and assesses the severity of anxiety symptoms.
Time Frame
Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)
Secondary Outcome Measure Information:
Title
Change in scores of Patient Health Questionnaire-9 (PHQ-9)
Description
PHQ-9 is a 9 item assessment that screens for depressive symptoms and assesses the severity of the depressive symptoms.
Time Frame
Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria for the study is as follows:
Patients who are at least 18 years of age.
Patients who have mild to moderate symptoms of anxiety (scores: 5-15, according to GAD-7).
Patients who are not already engaged in psychological therapy and not intending to start psychological therapy in the next eight weeks.
Patients who haven't used any DMHI (Digital Mental Health Interventions) in the last 6 months.
Patients without risk of suicidal ideation and behaviour.
Patients who are capable of reading and understanding English and have provided written or verbal informed consent to participate.
Patients who own and use a smartphone with functional audio.
Exclusion Criteria:
Patients who are at an increased risk of suicide.
Patients with diagnosis of or receiving treatment for alcohol/substance use disorder.
Patients who've had their psychiatric medication or dose changed in the last 1 month.
Patients who suffer from severe anxiety
Patients with diagnosis of or receiving treatment for an active state of psychosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaitali Sinha, M.A
Email
chaitali@wysa.io
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Main, PhD
Email
nicky@wysa.io
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with any external party as it does not comply with the terms of consent.
Citations:
PubMed Identifier
16717171
Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Results Reference
background
PubMed Identifier
11556941
Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
background
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Examining the Effectiveness of Wysa for Worry Program
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