Obsessive-Compulsive Disorder
Conditions
Keywords
Obsessive-Compulsive Disorder, OCD, randomized controlled trial, digital health
Brief 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.
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.
Interventions
DEVICEPerspectives OCD
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).
DEVICEThe Health and Well-Being Program
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.
Sponsors
Koa Health B.V.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in OCD Symptom Severity at the End of Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Depression at the End of Week 12 | Baseline (week 0), mid-treatment (week 6), end-of-treatment (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. |
| Difference in Functional Impairment at the End of Week 12 | Week 0, Week 6, and 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. |
| Difference in Quality of Life at the End of Week 12 | Week 0, Week 6, and 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perspectives OCD 12 week Smartphone-delivered CBT for OCD.
Perspectives OCD: The app-delivered 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). | 60 |
| The Health and Well-Being Program 12 week health and well-being education
The Health and Well-Being Program: 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. | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Follow-up | Lost to Follow-up | 8 | 7 |
| Treatment Phase | Adverse Event | 1 | 0 |
| Treatment Phase | Lost to Follow-up | 1 | 5 |
| Treatment Phase | Withdrawal by Subject | 1 | 9 |
Baseline characteristics
| Characteristic | Perspectives OCD | The Health and Well-Being Program | Total |
|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 14.7 | 41.1 years STANDARD_DEVIATION 15.6 | 40.1 years STANDARD_DEVIATION 15.1 |
| Current psychiatric comorbidities Agoraphobia | 3 Participants | 4 Participants | 7 Participants |
| Current psychiatric comorbidities Alcohol use disorder | 2 Participants | 5 Participants | 7 Participants |
| Current psychiatric comorbidities Binge eating disorder | 1 Participants | 2 Participants | 3 Participants |
| Current psychiatric comorbidities Body dysmorphic disorder | 5 Participants | 6 Participants | 11 Participants |
| Current psychiatric comorbidities Generalized anxiety disorder | 8 Participants | 11 Participants | 19 Participants |
| Current psychiatric comorbidities Major depression | 9 Participants | 8 Participants | 17 Participants |
| Current psychiatric comorbidities Panic disorder | 9 Participants | 1 Participants | 10 Participants |
| Current psychiatric comorbidities Social anxiety disorder | 7 Participants | 10 Participants | 17 Participants |
| Current psychotropic medication Antipsychotic | 1 Participants | 0 Participants | 1 Participants |
| Current psychotropic medication Benzodiazepine | 6 Participants | 1 Participants | 7 Participants |
| Current psychotropic medication None | 35 Participants | 37 Participants | 72 Participants |
| Current psychotropic medication Non-SRI antidepressant | 5 Participants | 9 Participants | 14 Participants |
| Current psychotropic medication Other psychotropic medication | 10 Participants | 13 Participants | 23 Participants |
| Current psychotropic medication Selective reuptake inhibitor (SRI) | 15 Participants | 18 Participants | 33 Participants |
| Duration of OCD | 23.9 years since onset STANDARD_DEVIATION 15.3 | 26.5 years since onset STANDARD_DEVIATION 16.4 | 25.2 years since onset STANDARD_DEVIATION 15.8 |
| Education College graduate | 21 Participants | 15 Participants | 36 Participants |
| Education Graduate or professional school | 15 Participants | 28 Participants | 43 Participants |
| Education High school graduate or less | 8 Participants | 5 Participants | 13 Participants |
| Education Technical school / some college | 16 Participants | 11 Participants | 27 Participants |
| Employment Employed full-time (>= 35 hours per week) | 27 Participants | 35 Participants | 62 Participants |
| Employment Employed part-time (< 35 hours per week) | 6 Participants | 6 Participants | 12 Participants |
| Employment Homemaker | 4 Participants | 5 Participants | 9 Participants |
| Employment Retired | 5 Participants | 2 Participants | 7 Participants |
| Employment Student | 6 Participants | 6 Participants | 12 Participants |
| Employment Unemployed | 11 Participants | 5 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 52 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Household income $150,000 or more | 4 Participants | 5 Participants | 9 Participants |
| Household income $34,999 or less | 21 Participants | 19 Participants | 40 Participants |
| Household income $35,000 - 74,999 | 13 Participants | 21 Participants | 34 Participants |
| Household income $75,000 - 149,999 | 20 Participants | 12 Participants | 32 Participants |
| Marital status Divorced / separated | 5 Participants | 5 Participants | 10 Participants |
| Marital status Married | 23 Participants | 28 Participants | 51 Participants |
| Marital status Partnered | 5 Participants | 3 Participants | 8 Participants |
| Marital status Single, never married | 26 Participants | 23 Participants | 49 Participants |
| Marital status Widowed | 1 Participants | 0 Participants | 1 Participants |
| Number of comorbid axis I disorders 1 | 12 Participants | 11 Participants | 23 Participants |
| Number of comorbid axis I disorders 2 | 6 Participants | 12 Participants | 18 Participants |
| Number of comorbid axis I disorders 3 or more | 6 Participants | 4 Participants | 10 Participants |
| Number of comorbid axis I disorders None | 36 Participants | 33 Participants | 69 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 48 Participants | 44 Participants | 92 Participants |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 50 Participants | 48 Participants | 98 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
| Sex/Gender, Customized Man | 10 Participants | 11 Participants | 21 Participants |
| Sex/Gender, Customized Transgender, non-binary, or questioning | 3 Participants | 3 Participants | 6 Participants |
| Sex/Gender, Customized Woman | 47 Participants | 46 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 23 / 60 | 27 / 60 |
| serious Total, serious adverse events | 1 / 60 | 0 / 60 |
Outcome results
Primary
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.
Time frame: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perspectives OCD | Difference in OCD Symptom Severity at the End of Week 12 | Week 0 | 25.12 score on a scale | Standard Deviation 4.22 |
| Perspectives OCD | Difference in OCD Symptom Severity at the End of Week 12 | Week 6 | 18.68 score on a scale | Standard Deviation 5.34 |
| Perspectives OCD | Difference in OCD Symptom Severity at the End of Week 12 | Week 12 | 16.14 score on a scale | Standard Deviation 6.48 |
| The Health and Well-Being Program | Difference in OCD Symptom Severity at the End of Week 12 | Week 0 | 23.77 score on a scale | Standard Deviation 4.6 |
| The Health and Well-Being Program | Difference in OCD Symptom Severity at the End of Week 12 | Week 6 | 20.49 score on a scale | Standard Deviation 5.32 |
| The Health and Well-Being Program | Difference in OCD Symptom Severity at the End of Week 12 | Week 12 | 18.15 score on a scale | Standard Deviation 5.67 |
Comparison: Null hypothesis: there is no significant difference in Y-BOCS total scores between the treatment groups at endpoint (week 12).p-value: 0.087195% CI: [-4.3977, 0.3027]Mixed Models Analysis
Comparison: Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment Y-BOCS total scores between the treatment groups.p-value: 0.003695% CI: [-5.7394, -1.1376]Mixed Models Analysis
Secondary
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.
Time frame: Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
Population: This was an 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 (see participant flow chart); a few more did not complete self-rated questionnaires after completing clinician-rated assessments (Perspectives OCD: n=1 at week 6, n=4 at week 12; Health and Well-Being Program: n=2 at week 6, n=2 at week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perspectives OCD | Difference in Depression at the End of Week 12 | Week 0 | 8.70 score on a scale | Standard Deviation 4.53 |
| Perspectives OCD | Difference in Depression at the End of Week 12 | Week 6 | 7.23 score on a scale | Standard Deviation 5.1 |
| Perspectives OCD | Difference in Depression at the End of Week 12 | Week 12 | 6.36 score on a scale | Standard Deviation 4.6 |
| The Health and Well-Being Program | Difference in Depression at the End of Week 12 | Week 0 | 8.27 score on a scale | Standard Deviation 4.11 |
| The Health and Well-Being Program | Difference in Depression at the End of Week 12 | Week 6 | 7.00 score on a scale | Standard Deviation 4.2 |
| The Health and Well-Being Program | Difference in Depression at the End of Week 12 | Week 12 | 6.84 score on a scale | Standard Deviation 4.89 |
Comparison: Null hypothesis: there is no significant difference in depression severity (QIDS-SR total scores) between the treatment groups at endpoint (week 12).p-value: 0.361695% CI: [-2.7666, 1.0181]Mixed Models Analysis
Comparison: Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment depression severity (QIDS-SR total scores) between the treatment groups.p-value: 0.197395% CI: [-3.3014, 0.6862]Mixed Models Analysis
Secondary
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.
Time frame: Week 0, Week 6, and Week 12
Population: This was an 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 (see participant flow chart); a few more did not complete self-rated questionnaires after completing clinician-rated assessments (Perspectives OCD: n=1 at week 6, n=4 at week 12; Health and Well-Being Program: n=1 at baseline, n=2 at week 6, n=1 at week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perspectives OCD | Difference in Functional Impairment at the End of Week 12 | Week 0 | 20.57 score on a scale | Standard Deviation 8.91 |
| Perspectives OCD | Difference in Functional Impairment at the End of Week 12 | Week 6 | 16.04 score on a scale | Standard Deviation 9.07 |
| Perspectives OCD | Difference in Functional Impairment at the End of Week 12 | Week 12 | 12.38 score on a scale | Standard Deviation 8.99 |
| The Health and Well-Being Program | Difference in Functional Impairment at the End of Week 12 | Week 0 | 18.80 score on a scale | Standard Deviation 7.7 |
| The Health and Well-Being Program | Difference in Functional Impairment at the End of Week 12 | Week 6 | 16.43 score on a scale | Standard Deviation 10.84 |
| The Health and Well-Being Program | Difference in Functional Impairment at the End of Week 12 | Week 12 | 14.98 score on a scale | Standard Deviation 9.97 |
Comparison: Null hypothesis: there is no significant difference in functional impairment (WSAS total scores) between the treatment groups at endpoint (week 12).p-value: 0.128995% CI: [-6.4246, 0.8262]Mixed Models Analysis
Comparison: Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment functional impairment (WSAS total scores) between the treatment groups.p-value: 0.013795% CI: [-8.1939, -0.9468]Mixed Models Analysis
Secondary
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).
Time frame: Week 0, Week 6, and Week 12
Population: This was an 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 (see participant flow chart); a few more did not complete self-rated questionnaires after completing clinician-rated assessments (Perspectives OCD: n=1 at week 6, n=4 at week 12; Health and Well-Being Program: n=1 at baseline, n=2 at week 6, n=1 at week 12).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Perspectives OCD | Difference in Quality of Life at the End of Week 12 | Week 6 | 62.93 percentage of the scale maximum score | Standard Deviation 15.79 |
| Perspectives OCD | Difference in Quality of Life at the End of Week 12 | Week 0 | 56.63 percentage of the scale maximum score | Standard Deviation 15.12 |
| Perspectives OCD | Difference in Quality of Life at the End of Week 12 | Week 12 | 66.87 percentage of the scale maximum score | Standard Deviation 16.82 |
| The Health and Well-Being Program | Difference in Quality of Life at the End of Week 12 | Week 0 | 59.02 percentage of the scale maximum score | Standard Deviation 14.79 |
| The Health and Well-Being Program | Difference in Quality of Life at the End of Week 12 | Week 6 | 62.54 percentage of the scale maximum score | Standard Deviation 16.26 |
| The Health and Well-Being Program | Difference in Quality of Life at the End of Week 12 | Week 12 | 63.04 percentage of the scale maximum score | Standard Deviation 16.26 |
Comparison: Null hypothesis: there is no significant difference in quality of life (Q-LES-Q-SF percentage scores) between the treatment groups at endpoint (week 12).p-value: 0.179695% CI: [-2.0543, 10.8448]Mixed Models Analysis
Comparison: Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment quality of life (Q-LES-Q-SF percentage scores) between the treatment groups.p-value: 0.0495% CI: [0.314, 13.2785]Mixed Models Analysis