Examining the Effectiveness of Wysa for Worry Program

Sponsor
Wysa (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05943418
Collaborator
(none)
500
2
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Wysa for Worry
  • Behavioral: App-based Psychoeducation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Control Trial with an intervention arm and a control arm.Randomized Control Trial with an intervention arm and a control arm.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Active Comparator: Control arm

Behavioral: App-based Psychoeducation
The control will include the weekly delivery of active psychoeducational resources.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wysa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wysa
ClinicalTrials.gov Identifier:
NCT05943418
Other Study ID Numbers:
  • Wysa_RCT_01
First Posted:
Jul 13, 2023
Last Update Posted:
Jul 13, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wysa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2023