Examining the Effectiveness of Wysa for Worry Program

Examining the Effectiveness of Wysa's Computerized Cognitive Behavioral Therapy Program (a Digital Mental Health Intervention) in Reducing Symptoms of Anxiety: Randomized Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Wysa for Worry; Behavioral: App-based Psychoeducation

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chaitali Sinha, M.A; Email: chaitali@wysa.io
• Study Contact Backup: Name: Nicole Main, PhD; Email: nicky@wysa.io

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm	Behavioral: App-based Psychoeducation; The control will include the weekly delivery of active psychoeducational resources.
Experimental: Active Intervention	Behavioral: Wysa for Worry; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)

Collaborators and Investigators

• Sponsor: Wysa

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Worry; Digital Mental Health
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Wysa_RCT_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with any external party as it does not comply with the terms of consent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No