Effectiveness of HabitWorks and Symptom Tracking for Anxi... | NCT07025486

Studies
Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression

NCT07025486

Sponsor

Mclean Hospital

Status

Completed

Last Update Posted

Jun 17, 2025Actual

Enrollment

340Actual

Phase

Not Applicable

Conditions

Anxiety
Depression, Anxiety

Interventions

HabitWorks
Symptom TRacking

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2024Actual

Primary Completion Date

Apr 4, 2025Actual

Completion Date

Apr 4, 2025Actual

First Submitted Date

Jun 9, 2025

First Submission Date that Met QC Criteria

Jun 9, 2025

First Posted Date

Jun 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2025

Last Update Posted Date

Jun 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Target engagement (improvement in interpretation bias)
Feasibility and acceptability of Symptom Tracking and HabitWorks and procedures for a general community sample
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HabitWorks + Symptom Tracking	Experimental	Use of HabitWorks app 3 times/week for 4 weeks + weekly symptom tracking	Behavioral: HabitWorks Behavioral: Symptom TRacking
Symptom Tracking	Active Comparator	Symptom Tracking 3 times per week for 4 weeks	Behavioral: Symptom TRacking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HabitWorks	Behavioral	Smartphone delivered interpretation bias exercises, symptom tracking	HabitWorks + Symptom Tracking

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
GAD-7	self-report measure of general anxiety symptoms, completed online via RedCap	From enrollment to the end of followup period at 8 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McLean Hospital		Belmont	Massachusetts	02478	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41926190	Derived	Silverman AL, Kovarsky Rotta G, Shin D, Ferguson I, Beard C. Randomized controlled trial of smartphone-based interpretation bias intervention for anxiety and depression. J Consult Clin Psychol. 2026 Mar;94(3):125-139. doi: 10.1037/ccp0000996.

ID	Term
D001008	Anxiety Disorders
D003863	Depression

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior