Obsessive-Compulsive DisorderNCT04136626

Digital Health Interventions for Obsessive Compulsive Disorder (OCD)

A study testing Perspectives OCD and The Health and Well-Being Program in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators are testing two digital health interventions for obsessive compulsive disorder (OCD). The investigators hope that these digital health programs will increase access to treatment for OCD. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obsessive-Compulsive Disorder
What is being tested?: Perspectives OCD and The Health and Well-Being Program
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 26 Jul 2021to 25 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

At least 18 years of age
Current diagnosis of primary obsessive compulsive disorder (OCD), based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Mini International Neuropsychiatric Interview (MINI)
Currently living in the United States

Who cannot join

Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
Past participation in ≥4 sessions of cognitive behavioral therapy (CBT) for OCD
Past use of a CBT for OCD app
Current severe substance use disorder
Lifetime bipolar disorder or psychosis
Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥2 on the suicidal ideation subscale of the Columbia Suicide Severity Rating Scale (C-SSRS).

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Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology, self-report version (QIDS-SR), total score ≥ 21
Current post-traumatic stress disorder (PTSD)
Concurrent psychological treatment
Does not own a supported mobile smartphone with a data plan
Lack of technology literacy that would interfere with ability to engage with smartphone treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Digital Health Interventions for Obsessive Compulsive Disorder: A Randomized Controlled Trial

Read the detailed description

The primary aims of this study are to test the feasibility, acceptability, and efficacy of two digital health interventions for adults with OCD recruited nationally. Eligible subjects (N=120) will be randomly assigned (50/50 chance) to 12 weeks of app-based CBT on their personal Smartphone or 12 weeks of web-based health and well-being education in addition to completing clinical assessments and questionnaires from home. All participants will have access to a coach to help guide them through their assigned program. Total participation time for the study is approximately 6 months, and all study appointments (5 total) occur over secure phone or video conference call.

Conditions: Obsessive-Compulsive Disorder
Being tested: Perspectives OCD, The Health and Well-Being Program
Keywords: Obsessive-Compulsive Disorder, OCD, randomized controlled trial, digital health
Medical subject headings: Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Perspectives OCDDevice
The app-delivered cognitive behavioral therapy (CBT) in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work) and behavioral skills (e.g., exposure and response prevention).
The Health and Well-Being ProgramDevice
The website includes 12 modules related to general health and well-being (e.g., sleep and nutrition). Each module contains educational information and questions about an indvidual's experience with the given topic.

Study groups in NCT04136626
Study group	Role	What they receive
Perspectives OCD	Experimental	12 week Smartphone-delivered cognitive behavioral therapy (CBT) for OCD. Receives: Device: Perspectives OCD
The Health and Well-Being Program	Active comparator	12 week health and well-being education Receives: Device: The Health and Well-Being Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in OCD Symptom Severity at the End of Week 12
Symptom severity for OCD was measured with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range 0 to 40). Higher scores indicate more severe OCD symptoms.
Measured: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)

Secondary outcomes (3)

Difference in Depression at the End of Week 12
The Quick Inventory of Depressive Symptomatology (Self-report; QIDS-SR) is a self-report measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Total scores range from 0 to 27 with higher scores indicating greater depression severity. The measure is a well-validated, sensitive measure of symptom severity in depression.
Measured: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
Difference in Functional Impairment at the End of Week 12
Functional impairment was assessed using the Work and Social Adjustment Scale (WSAS). This scale uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in a person's ability to function in terms of work, home management, leisure activities. Total scores total range from 0-40, where higher scores indicate greater impairment.
Measured: Week 0, Week 6, and Week 12
Difference in Quality of Life at the End of Week 12
The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100), with higher scores indicating greater quality of life).
Measured: Week 0, Week 6, and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 202125 Oct 2024

First posted23 Oct 2019
Study start26 Jul 2021
Primary completion6 Oct 2023
Study completion25 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
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: Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04136626
Sponsor's protocol ID: 2018P001669
Status last verified: Nov 2024
First submitted: 17 Oct 2019
Last updated: 25 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Wilhelm S, Greenberg JL, Jacoby RJ, Weingarden H, Hoeppner SS, Klare D, Snorrason I, Jaroszewski AC, McCoy TH, Harrison O. A randomized clinical trial of app cognitive behavior therapy vs. HealthWatch for obsessive compulsive disorder. NPJ Digit Med. 2025 Dec 15;8(1):800. doi: 10.1038/s41746-025-02230-9.
PubMed 41398456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obsessive-Compulsive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Digital Health Interventions for Obsessive Compulsive Disorder: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04136626
Acronym / sponsor ID: 2018P001669
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder, OCD, randomized controlled trial, digital health
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Koa Health B.V.
Study start: 26 Jul 2021 (actual)
Primary completion: 6 Oct 2023 (actual)
Study completion: 25 Oct 2024 (actual)
First posted: 23 Oct 2019 (actual)
Results: Posted 25 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Perspectives OCD	Experimental	Device: Perspectives OCD12 week Smartphone-delivered cognitive behavioral therapy (CBT) for OCD.
The Health and Well-Being Program	Active comparator	Device: The Health and Well-Being Program12 week health and well-being education

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

At least 18 years of age
Current diagnosis of primary obsessive compulsive disorder (OCD), based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Mini International Neuropsychiatric Interview (MINI)
Currently living in the United States

Key exclusion criteria (11 listed)

Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
Past participation in ≥4 sessions of cognitive behavioral therapy (CBT) for OCD
Past use of a CBT for OCD app
Current severe substance use disorder
Lifetime bipolar disorder or psychosis

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
Perspectives OCDThe app-delivered cognitive behavioral therapy (CBT) in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work) and behavioral skills (e.g., exposure and response prevention).	Device	Perspectives OCD
The Health and Well-Being ProgramThe website includes 12 modules related to general health and well-being (e.g., sleep and nutrition). Each module contains educational information and questions about an indvidual's experience with the given topic.	Device	The Health and Well-Being Program

Primary outcome

Difference in OCD Symptom Severity at the End of Week 12
Time frame: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
Symptom severity for OCD was measured with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the gold-standard, semi-structured clinician-administered assessment of OCD severity. It contains 10 items ranging from 0 to 4, which are summed to generate a total score (range 0 to 40). Higher scores indicate more severe OCD symptoms.

3 secondary outcomes

Difference in Depression at the End of Week 12
Time frame: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
Difference in Functional Impairment at the End of Week 12
Time frame: Week 0, Week 6, and Week 12
Difference in Quality of Life at the End of Week 12
Time frame: Week 0, Week 6, and Week 12

Results and safety

Results posted to the registry on 25 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Perspectives OCD	60	57
The Health and Well-Being Program	60	46

Primary outcome: Difference in OCD Symptom Severity at the End of Week 12

Time frame: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12). Mean (Standard Deviation). Unit: score on a scale

Measure	Perspectives OCD n = 60	The Health and Well-Being Program n = 60
Week 0	25.12 (4.22)	23.77 (4.60)
Week 6	18.68 (5.34)	20.49 (5.32)
Week 12	16.14 (6.48)	18.15 (5.67)

Perspectives OCD vs The Health and Well-Being Program: Mean Difference (Final Values): -2.0475 (95% CI -4.3977 to 0.3027), p = 0.0871, Mixed Models Analysis
Perspectives OCD vs The Health and Well-Being Program: Difference in the amount of change: -3.4385 (95% CI -5.7394 to -1.1376), p = 0.0036, Mixed Models Analysis

Population analysed: Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 6) or end-of-treatment (week 12) assessments.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected every 6 weeks after the baseline visit, during the mid-treatment assessment visit (week 6) and the post-treatment visit (week 12). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 6 weeks prior).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Perspectives OCD	1 of 60 (1.7%)	23 of 60 (38.3%)	0 of 60
The Health and Well-Being Program	0 of 60 (0%)	27 of 60 (45%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41398456Wilhelm S, Greenberg JL, Jacoby RJ, Weingarden H, Hoeppner SS, Klare D, Snorrason I, Jaroszewski AC, McCoy TH, Harrison O. A randomized clinical trial of app cognitive behavior therapy vs. HealthWatch for obsessive compulsive disorder. NPJ Digit Med. 2025 Dec 15;8(1):800. doi: 10.1038/s41746-025-02230-9.

Related trials for Obsessive-Compulsive Disorder

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
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Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
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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.

Sabine Wilhelm, Ph.D. principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Perspectives OCD and The Health and Well-Being Program in people with Obsessive-Compulsive Disorder, run by Massachusetts General 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 3 inclusion and 11 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 25 Nov 2024. 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?

Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Difference in OCD Symptom Severity at the End of Week 12 (time frame: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)). 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 NCT04136626, 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 25 Nov 2024.