Anxiety, Depression, Anxiety
Conditions
Keywords
interpretation bias, digital mental health
Brief summary
Our objective is to conduct a randomized controlled trial (RCT) that compares two digital interventions - Symptom Tracking and the HabitWorks app - in a sample of adults endorsing symptoms of anxiety or depression. We hope to obtain pilot data to support a fully powered RCT to test moderators: 1. Target engagement (improvement in interpretation bias) 2. Feasibility and acceptability of Symptom Tracking and HabitWorks and procedures for a general community sample 3. Symptom and functioning measures
Detailed description
HabitWorks is a personalized, transdiagnostic, smartphone-delivered interpretation bias intervention. Our pilot studies of HabitWorks revealed good acceptability, feasibility, and target engagement in a variety of populations (Beard, Ramadurai, et al., 2021; Beard, Beckham, et al., 2021). Our next step is to test effectiveness for anxiety and depression symptoms in a larger, community sample. Results will provide pilot data to support an R01 effectiveness trial. We will randomize adults with anxiety or depression to HabitWorks or a credible control arm and examine effects on interpretation bias, symptoms, and functioning.
Interventions
BEHAVIORALHabitWorks
Smartphone delivered interpretation bias exercises, symptom tracking
BEHAVIORALSymptom TRacking
Self-assessment via symptom surveys
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 at the time of consent (19 in Nebraska, 21 in Puerto Rico based on age of consent) 2. Current US resident 3. Total score ≥ 3 on the Patient Health Questionnaire-2 (Kroenke et al., 2003) or Generalized Anxiety Disorder-2 (Spitzer et al., 2006), indicating at least mild depression and/or anxiety symptoms 4. 24-hour access to an iPhone smartphone 5. ability to understand English
Exclusion criteria
1. No current psychiatric symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., active symptoms of psychosis, mania) 2. No medical symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., physical disability)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GAD-7 | From enrollment to the end of followup period at 8 weeks | self-report measure of general anxiety symptoms, completed online via RedCap |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Improvement Scale | post-treatment (4 weeks after enrollment) | self-reported single item assessing perceived improvement due to a treatment |
Countries
United States
Outcome results
None listed