AnxietyNCT07025486
Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression
A study testing HabitWorks and Symptom TRacking in people with Anxiety and Depression, Anxiety, run by Mclean Hospital at 1 site in United States.
Trial summary
The 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. The investigators hope to obtain pilot data to support a fully powered RCT to test moderators: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Anxiety
- What is being tested?
- HabitWorks and Symptom TRacking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2024to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
The 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. The investigators 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
Read the detailed description
HabitWorks is a personalized, transdiagnostic, smartphone-delivered interpretation bias intervention. Pilot studies of HabitWorks revealed good acceptability, feasibility, and target engagement in a variety of populations. The 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. The investigators will randomize adults with anxiety or depression to HabitWorks or a credible control arm and examine effects on interpretation bias, symptoms, and functioning.
- Conditions
- Anxiety, Depression, Anxiety
- Being tested
- HabitWorks, Symptom TRacking
- Keywords
- interpretation bias, digital mental health
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HabitWorksBehavioural
Smartphone delivered interpretation bias exercises, symptom tracking
Symptom TRackingBehavioural
Self-assessment via symptom surveys
| Study group | Role | What they receive |
|---|---|---|
| HabitWorks + Symptom Tracking | Experimental | Use of HabitWorks app 3 times/week for 4 weeks + weekly symptom tracking Receives: Behavioral: HabitWorks; Behavioral: Symptom TRacking |
| Symptom Tracking | Active comparator | Symptom Tracking 3 times per week for 4 weeks Receives: Behavioral: Symptom TRacking |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAD-7
self-report measure of general anxiety symptoms, completed online via RedCap
Measured: From enrollment to the end of followup period at 8 weeks
Secondary outcomes (1)
Clinical Global Improvement Scale
self-reported single item assessing perceived improvement due to a treatment
Measured: post-treatment (4 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start13 Mar 2024
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Beard, PhD, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025486
- Sponsor's protocol ID
- 2022P001752
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: STudy protocol, statistical plan, analytic code will be shared on open science framework
Publications
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.
PubMed 41926190
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of HabitWorks and Symptom Tracking for Anxiety and Depression
- ClinicalTrials.gov ID
- NCT07025486
- Acronym / sponsor ID
- 2022P001752
- Conditions
- Anxiety, Depression, Anxiety
- Keywords
- interpretation bias, digital mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 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. The investigators 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. Pilot studies of HabitWorks revealed good acceptability, feasibility, and target engagement in a variety of populations. The 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. The investigators will randomize adults with anxiety or depression to HabitWorks or a credible control arm and examine effects on interpretation bias, symptoms, and functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HabitWorks + Symptom Tracking | Experimental | Behavioral: HabitWorks, Behavioral: Symptom TRackingUse of HabitWorks app 3 times/week for 4 weeks + weekly symptom tracking |
| Symptom Tracking | Active comparator | Behavioral: Symptom TRackingSymptom Tracking 3 times per week for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HabitWorksSmartphone delivered interpretation bias exercises, symptom tracking | Behavioural | HabitWorks + Symptom Tracking |
| Symptom TRackingSelf-assessment via symptom surveys | Behavioural | HabitWorks + Symptom Tracking, Symptom Tracking |
Primary outcome
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
1 secondary outcome
Clinical Global Improvement Scale
Time frame: post-treatment (4 weeks after enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 41926190Silverman 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.
- Individual participant dataSharing planned: Yes. STudy protocol, statistical plan, analytic code will be shared on open science framework
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HabitWorks and Symptom TRacking in people with Anxiety and Depression, Anxiety, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAD-7 (time frame: From enrollment to the end of followup period at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025486, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.