Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression

NCT ID: NCT07025486

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2025-04-04

Brief Summary

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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

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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.

Conditions

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Anxiety Depression, Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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HabitWorks + Symptom Tracking

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

Group Type EXPERIMENTAL

HabitWorks

Intervention Type BEHAVIORAL

Smartphone delivered interpretation bias exercises, symptom tracking

Symptom TRacking

Intervention Type BEHAVIORAL

Self-assessment via symptom surveys

Symptom Tracking

Symptom Tracking 3 times per week for 4 weeks

Group Type ACTIVE_COMPARATOR

Symptom TRacking

Intervention Type BEHAVIORAL

Self-assessment via symptom surveys

Interventions

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HabitWorks

Smartphone delivered interpretation bias exercises, symptom tracking

Intervention Type BEHAVIORAL

Symptom TRacking

Self-assessment via symptom surveys

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Courtney Beard, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2022P001752

Identifier Type: -

Identifier Source: org_study_id

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