Examining the Effectiveness of Wysa for Worry Program

NCT ID: NCT05943418

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-03-31

Brief Summary

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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

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial with an intervention arm and a control arm.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active Intervention

Group Type EXPERIMENTAL

Wysa for Worry

Intervention Type 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.

Control arm

Group Type ACTIVE_COMPARATOR

App-based Psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

App-based Psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wysa

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Chaitali Sinha, M.A

Role: CONTACT

Nicole Main, PhD

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

Other Identifiers

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Wysa_RCT_01

Identifier Type: -

Identifier Source: org_study_id

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