Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression

Mass General Brigham

Status: Completed

Conditions: Depression, Anxiety; Anxiety

Treatments: Behavioral: HabitWorks; Behavioral: Symptom TRacking

Study type: Interventional

Funder types: Other

Identifiers

NCT07025486

2022P001752

Details and patient eligibility

About

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

Full 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.

Enrollment: 340 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups

HabitWorks + Symptom Tracking

Experimental group

Description:

Use of HabitWorks app 3 times/week for 4 weeks + weekly symptom tracking

Treatment:

Behavioral: Symptom TRacking

Behavioral: HabitWorks

Symptom Tracking

Active Comparator group

Description:

Symptom Tracking 3 times per week for 4 weeks

Treatment:

Behavioral: Symptom TRacking