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| Name | Class |
|---|---|
| Koa Health B.V. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perspectives OCD | Experimental | 12 week Smartphone-delivered cognitive behavioral therapy (CBT) for OCD. |
|
| The Health and Well-Being Program | Active Comparator | 12 week health and well-being education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perspectives OCD | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Wilhelm, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41398456 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
| |||||||||||||||||||||
| 12-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | The Health and Well-Being Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12) |
|
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).
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of mental health resulting in inpatient hospitalization | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal problems including diarrhea, norovirus, Crohn's disease, acid reflux | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sabine Wilhelm, Chief of Psychology | Massachusetts General Hospital | 617-724-6146 | swilhelm@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2022 | Oct 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| The Health and Well-Being Program | Device | 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. |
|
| 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. | 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). | Week 0, Week 6, and Week 12 |
| Lost to Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Gender identity, self-reported | Count of Participants | Participants |
|
| Sex: Female, Male | One participant in the Health and Well-Being Program group did not provide data for sex at birth. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | One participant in the Health and Well-Being Program group did not provide data for education. | Count of Participants | Participants |
|
| Marital status | One participant in the Health and Well-Being Program group did not provide data for marital status. | Count of Participants | Participants |
|
| Employment | One participant in each treatment group did not provide data for employment status. | Count of Participants | Participants |
|
| Household income | Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group). | Count of Participants | Participants |
|
| Duration of OCD | Mean | Standard Deviation | years since onset |
|
| Current psychiatric comorbidities | Clinician-assessed, based on the Miniature Neuropsychiatric Interview (MINI) | The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group. | Count of Participants | Participants |
|
| Number of comorbid axis I disorders | We used the Mini International Neuropsychiatric Interview (M.I.N.I., English Version 7.0.2) to assess the most common psychiatric disorders and suicidality. The MINI was designed as a brief structured diagnostic interview to meet the need for a short but accurate structured psychiatric interview for clinical trials and studies. The MINI is a relatively short, structured clinical interview with very precise questions about psychological problems which require a yes or no answer from participants. In our study, the MINI was administered by trained clinicians. | Count of Participants | Participants |
|
| Current psychotropic medication | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12) |
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 6, and Week 12 |
|
|
|
|
| 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). | 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). | Posted | Mean | Standard Deviation | percentage of the scale maximum score | Week 0, Week 6, and Week 12 |
|
|
|
|
| 0 |
| 60 |
| 1 |
| 60 |
| 23 |
| 60 |
| EG001 | 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. | 0 | 60 | 0 | 60 | 27 | 60 |
| COVID-19 and/or flu | Infections and infestations | Non-systematic Assessment |
|
| arthritis, leg/foot pain, muscle spasms, muscle tension, herniated disc, tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| increased depression, anxiety, and/or irritability | Psychiatric disorders | Non-systematic Assessment |
|
| worsening of OCD symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| stress and anxiety due to job, relationships, death of a loved one, or household problems | Social circumstances | Non-systematic Assessment |
|
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| College graduate |
|
| Graduate or professional school |
|
| Partnered |
|
| Divorced / separated |
|
| Widowed |
|
| Student |
|
| Unemployed |
|
| Retired |
|
| Homemaker |
|
| $75,000 - 149,999 |
|
| $150,000 or more |
|
| 2 |
|
| 3 or more |
|
| Week 6 |
|
|
| Week 12 |
|
|
| Superiority |
| 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. | Mixed Models Analysis | Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure. | 0.1973 | The a priori threshold for statistical significance was alpha=.05. | Difference in the amount of change | -1.3076 | 2-Sided | 95 | -3.3014 | 0.6862 | The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time). | Superiority |
| Week 6 |
|
|
| Week 12 |
|
|
| Superiority |
| 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. | Mixed Models Analysis | Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure. | 0.0137 | The a priori threshold for statistical significance was alpha=.05. | Difference in the amount of change | -4.5704 | 2-Sided | 95 | -8.1939 | -0.9468 | The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time). | Superiority |
| Week 6 |
|
|
| Week 12 |
|
|
| Superiority |
| 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. | Mixed Models Analysis | Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure. | 0.0400 | The a priori threshold for statistical significance was alpha=.05. | Difference in the amount of change | 6.7962 | 2-Sided | 95 | 0.3140 | 13.2785 | The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time). | Superiority |