Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression

Mclean Hospital340 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

340

Conditions

Anxiety Depression, Anxiety

Interventions

HabitWorksBEHAVIORAL

Smartphone delivered interpretation bias exercises, symptom tracking

Symptom TRackingBEHAVIORAL

Self-assessment via symptom surveys

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

McLean Hospital

Belmont, Massachusetts, United States

Outcomes

Primary Outcomes

GAD-7

self-report measure of general anxiety symptoms, completed online via RedCap

Time frame: From enrollment to the end of followup period at 8 weeks

Secondary Outcomes

Clinical Global Improvement Scale

self-reported single item assessing perceived improvement due to a treatment

Time frame: post-treatment (4 weeks after enrollment)

Data from ClinicalTrials.gov

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