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OpenTrials
Completed

NCT Number: NCT07025486

Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 at the time of consent (19 in Nebraska, 21 in Puerto Rico based on age of consent)
  • Current US resident
  • 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
  • 24-hour access to an iPhone smartphone
  • ability to understand English

Exclusion criteria

  • 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)
  • No medical symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., physical disability)

Treatment and study plan

HabitWorks

Behavioral

Smartphone delivered interpretation bias exercises, symptom tracking

Symptom TRacking

Behavioral

Self-assessment via symptom surveys

Primary outcomes

  1. GAD-7

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

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

Secondary outcomes

  1. Clinical Global Improvement Scale

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

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

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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