Examining the Effectiveness of Wysa for Worry Program

Not Applicable

Not yet recruiting

• Conditions: Anxiety
• Interventions: Behavioral: Wysa for Worry; Behavioral: App-based Psychoeducation

• Registration Number: NCT05943418
• Lead Sponsor: Wysa

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.

Study Timeline

• Study First Submitted: 2023-06-19
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-04
• Last Update Submitted: 2023-07-04
• Study First Posted: 2023-07-13
• Last Update Posted: 2023-07-13
• Study Start: 2023-08
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Intervention	Wysa for Worry	-
Control arm	App-based Psychoeducation	-

Primary Outcome Measures

Name	Time	Method
Change in scores of Generalized Anxiety Disorder Scale (GAD-7)	Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)	GAD-7 is a 7 item assessment that screens for anxiety and assesses the severity of anxiety symptoms.

Secondary Outcome Measures

Name	Time	Method
Change in scores of Patient Health Questionnaire-9 (PHQ-9)	Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)	PHQ-9 is a 9 item assessment that screens for depressive symptoms and assesses the severity of the depressive symptoms.