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N/A N=120 Randomized Single-blind Treatment

Digital Health Interventions for Obsessive Compulsive Disorder (OCD)

Obsessive-Compulsive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT04136626 ↗
Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Nov 2024
Primary outcome: Primary: Difference in OCD Symptom Severity at the End of Week 12 — 25.12; 23.77; 18.68; 20.49 score on a scale — p=0.0871

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Perspectives OCD (Device); The Health and Well-Being Program (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Oct 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Difference in OCD Symptom Severity at the End of Week 12		 25.12; 23.77; 18.68; 20.49; 16.14; 18.15 0.0871
SECONDARY
Difference in Depression at the End of Week 12		 8.70; 8.27; 7.23; 7.00; 6.36; 6.84 0.3616
SECONDARY
Difference in Functional Impairment at the End of Week 12		 20.57; 18.80; 16.04; 16.43; 12.38; 14.98 0.1289
SECONDARY
Difference in Quality of Life at the End of Week 12		 56.63; 59.02; 62.93; 62.54; 66.87; 63.04 0.1796

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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).
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04136626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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