Clinical Outcomes of a Digital Mental Health Intervention for Moderate/Severe Depression and Anxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTeladoc Health
About this trial
A digital mental health intervention (BetterHelp, Mountain View, CA) provides users with access to online therapy care for treatment of depression and anxiety. This feasibility randomized controlled trial compares clinical outcomes of an intervention group, who will enroll in the digital mental health platform, to a control group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Has moderate or severe baseline anxiety or depression, as defined by GAD-7 ≥ 10 or PHQ-9 ≥ 10, respectively
Based in the US
Fluent in the English language
Disqualifiers
Pregnant or plan on becoming pregnant in the next 6 months
Has no or mild baseline anxiety or depression, as defined by GAD-7 < 10 and PHQ-9 < 10, respectively
Trial design
Design model
Parallel
Treatments tested in this trial
BetterHelp
Other interventionUse program as needed for 16 weeks
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment
Recruitment rates for study participation
Time frame
90 days2
Adherence
Adherence rates to study procedures
Time frame
90 daysSecondary outcomes
1
GAD-7
Anxiety will be measured by the Generalized Anxiety Disorder Scale (GAD-7), ranging from 0 (no anxiety) to 21 (severe anxiety). The percentage of participants who achieved a minimal clinically important difference (MCID) of 4 points or more will also be reported for each group, as based on literature.
Time frame
Baseline, 45 days, 90 days2
PHQ-9
Depression will be measured by the Patient Health Questionnaire (PHQ-9), ranging from 0 (no depression) to 27 (severe depression). The percentage of participants who achieved a minimal clinically important difference (MCID) of 5 points or more will also be reported for each group, as based on literature.
Time frame
Baseline, 45 days, 90 daysOther outcomes
1
Workplace Productivity
Workplace productivity will be measured by the Work Productivity and Activity Impairment Questionnaire (WPAI) and reported for both groups.
Time frame
Baseline, 45 days, 90 days2
Sleep
Sleep quality will be measured by the Jenkins Sleep Scale (JSS-4) and reported for both groups.
Time frame
Baseline, 45 days, 90 days3
Stress
Stress levels will be measured by the Perceived Stress Scale (PSS-10) and reported for both groups.
Time frame
Baseline, 45 days, 90 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Teladoc Health
Lead sponsor
BetterHelp
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: