Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression

Not Applicable

Completed

• Conditions: Anxiety; Depression, Anxiety

• Registration Number: NCT07025486
• Lead Sponsor: Mclean Hospital

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.

Study Timeline

• Study Start: 2024-03-13
• Primary Completion: 2025-04-04
• Study Completion: 2025-04-04
• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical Global Improvement Scale	post-treatment (4 weeks after enrollment)	self-reported single item assessing perceived improvement due to a treatment

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 BElmont, Massachusetts, United States