Examining the Effectiveness of Wysa for Worry Program

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05943418
• Other study ID #: Wysa_RCT_01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: March 2024

Study information

• Verified date: July 2023
• Source: Wysa
• Contact: Chaitali Sinha, M.A
• Email: chaitali[@]wysa.io
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wysa

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)