Examining the Effectiveness of Wysa for Worry Program

NCT05943418 | Unknown

• 1 other identifier: Wysa_RCT_01
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety

Keywords

Worry; Anxiety; Digital Mental Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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)

Study Arms (2)

Active Intervention

EXPERIMENTAL

Behavioral: Wysa for Worry

Control arm

ACTIVE COMPARATOR

Behavioral: App-based Psychoeducation

Interventions

Wysa for Worry BEHAVIORAL

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 Intervention

App-based Psychoeducation BEHAVIORAL

The control will include the weekly delivery of active psychoeducational resources.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wysa: lead

Related Publications (2)

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Chaitali Sinha, M.A

CONTACT

chaitali@wysa.io

Nicole Main, PhD

CONTACT

nicky@wysa.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial with an intervention arm and a control arm.

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 13, 2023
• Study Start: August 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share