Clinical trial NCT05943418: Examining the Effectiveness of Wysa for Worry Program
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Worry
Anxiety
Digital Mental Health
Lead sponsor: Wysa
Sponsor class: INDUSTRY
First posted: 2023-07-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial with an intervention arm and a control arm.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in scores of Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)
Secondary outcomes:
measure: Change in scores of Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Weekly assessments for 7 weeks, Post intervention assessment (one month after the participant finishes the intervention)
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.