AnxietyNCT05943418
Examining the Effectiveness of Wysa for Worry Program
A study testing Wysa for Worry and App-based Psychoeducation in people with Anxiety, run by Wysa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Wysa for Worry and App-based Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Chaitali Sinha, M.A contact
Nicole Main, PhD contact
About this study
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
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Wysa for Worry, App-based Psychoeducation
- Keywords
- Worry, Anxiety, Digital Mental Health
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wysa for WorryBehavioural
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 PsychoeducationBehavioural
The control will include the weekly delivery of active psychoeducational resources.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | Not described Receives: Behavioral: Wysa for Worry |
| Control arm | Active comparator | Not described Receives: Behavioral: App-based Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
PHQ-9 is a 9 item assessment that screens for depressive symptoms and assesses the severity of the depressive symptoms.
Measured: Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial with an intervention arm and a control arm.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wysa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943418
- Sponsor's protocol ID
- Wysa_RCT_01
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with any external party as it does not comply with the terms of consent.
Publications
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.
PubMed 16717171Kroenke 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.
PubMed 11556941
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05943418
- Acronym / sponsor ID
- Wysa_RCT_01
- Conditions
- Anxiety
- Keywords
- Worry, Anxiety, Digital Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- WysaIndustry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial with an intervention arm and a control arm.
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Behavioral: Wysa for Worry |
| Control arm | Active comparator | Behavioral: App-based Psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The inclusion criteria for the study is as follows:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wysa for WorryThe 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. | Behavioural | Active Intervention |
| App-based PsychoeducationThe control will include the weekly delivery of active psychoeducational resources. | Behavioural | Control arm |
Primary outcome
Change in scores of Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 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.
1 secondary outcome
Change in scores of Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 11556941Kroenke 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with any external party as it does not comply with the terms of consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaitali Sinha, M.A contact
Nicole Main, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Wysa for Worry and App-based Psychoeducation in people with Anxiety, run by Wysa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaitali Sinha, M.A (chaitali@wysa.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores of Generalized Anxiety Disorder Scale (GAD-7) (time frame: Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943418, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.