Trial Outcomes & Findings for Digital Health Interventions for Obsessive Compulsive Disorder (OCD) (NCT NCT04136626)

NCT ID: NCT04136626

Last Updated: 2024-11-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)

Results posted on

2024-11-25

Participant Flow

Participant milestones

Participant milestones
Measure
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).
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.
Treatment Phase
STARTED
60
60
Treatment Phase
COMPLETED
57
46
Treatment Phase
NOT COMPLETED
3
14
12-month Follow-up
STARTED
57
46
12-month Follow-up
3-month Follow-up
52
41
12-month Follow-up
COMPLETED
49
39
12-month Follow-up
NOT COMPLETED
8
7

Reasons for withdrawal

Reasons for withdrawal
Measure
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).
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.
Treatment Phase
Withdrawal by Subject
1
9
Treatment Phase
Adverse Event
1
0
Treatment Phase
Lost to Follow-up
1
5
12-month Follow-up
Lost to Follow-up
8
7

Baseline Characteristics

One participant in the Health and Well-Being Program group did not provide data for sex at birth.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Perspectives OCD
n=60 Participants
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).
The Health and Well-Being Program
n=60 Participants
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.
Total
n=120 Participants
Total of all reporting groups
Age, Continuous
39.0 years
STANDARD_DEVIATION 14.7 • n=60 Participants
41.1 years
STANDARD_DEVIATION 15.6 • n=60 Participants
40.1 years
STANDARD_DEVIATION 15.1 • n=120 Participants
Sex/Gender, Customized
Woman
47 Participants
n=60 Participants
46 Participants
n=60 Participants
93 Participants
n=120 Participants
Sex/Gender, Customized
Man
10 Participants
n=60 Participants
11 Participants
n=60 Participants
21 Participants
n=120 Participants
Sex/Gender, Customized
Transgender, non-binary, or questioning
3 Participants
n=60 Participants
3 Participants
n=60 Participants
6 Participants
n=120 Participants
Sex: Female, Male
Female
50 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for sex at birth.
48 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for sex at birth.
98 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for sex at birth.
Sex: Female, Male
Male
10 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for sex at birth.
11 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for sex at birth.
21 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for sex at birth.
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=60 Participants
8 Participants
n=60 Participants
11 Participants
n=120 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
57 Participants
n=60 Participants
52 Participants
n=60 Participants
109 Participants
n=120 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=60 Participants
0 Participants
n=60 Participants
0 Participants
n=120 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=60 Participants
1 Participants
n=60 Participants
1 Participants
n=120 Participants
Race (NIH/OMB)
Asian
2 Participants
n=60 Participants
4 Participants
n=60 Participants
6 Participants
n=120 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=60 Participants
1 Participants
n=60 Participants
1 Participants
n=120 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=60 Participants
3 Participants
n=60 Participants
7 Participants
n=120 Participants
Race (NIH/OMB)
White
48 Participants
n=60 Participants
44 Participants
n=60 Participants
92 Participants
n=120 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=60 Participants
4 Participants
n=60 Participants
8 Participants
n=120 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=60 Participants
3 Participants
n=60 Participants
5 Participants
n=120 Participants
Region of Enrollment
United States
60 participants
n=60 Participants
60 participants
n=60 Participants
120 participants
n=120 Participants
Education
High school graduate or less
8 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
5 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
13 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
Education
Technical school / some college
16 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
11 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
27 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
Education
College graduate
21 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
15 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
36 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
Education
Graduate or professional school
15 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
28 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
43 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for education.
Marital status
Single, never married
26 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
23 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
49 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
Marital status
Married
23 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
28 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
51 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
Marital status
Partnered
5 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
3 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
8 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
Marital status
Divorced / separated
5 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
5 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
10 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
Marital status
Widowed
1 Participants
n=60 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
0 Participants
n=59 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
1 Participants
n=119 Participants • One participant in the Health and Well-Being Program group did not provide data for marital status.
Employment
Employed full-time (>= 35 hours per week)
27 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
35 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
62 Participants
n=118 Participants • One participant in each treatment group did not provide data for employment status.
Employment
Employed part-time (< 35 hours per week)
6 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
6 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
12 Participants
n=118 Participants • One participant in each treatment group did not provide data for employment status.
Employment
Student
6 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
6 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
12 Participants
n=118 Participants • One participant in each treatment group did not provide data for employment status.
Employment
Unemployed
11 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
5 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
16 Participants
n=118 Participants • One participant in each treatment group did not provide data for employment status.
Employment
Retired
5 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
2 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
7 Participants
n=118 Participants • One participant in each treatment group did not provide data for employment status.
Employment
Homemaker
4 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
5 Participants
n=59 Participants • One participant in each treatment group did not provide data for employment status.
9 Participants
n=118 Participants • One participant in each treatment group did not provide data for employment status.
Household income
$34,999 or less
21 Participants
n=58 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
19 Participants
n=57 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
40 Participants
n=115 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
Household income
$35,000 - 74,999
13 Participants
n=58 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
21 Participants
n=57 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
34 Participants
n=115 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
Household income
$75,000 - 149,999
20 Participants
n=58 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
12 Participants
n=57 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
32 Participants
n=115 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
Household income
$150,000 or more
4 Participants
n=58 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
5 Participants
n=57 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
9 Participants
n=115 Participants • Five participants did not provide income data (2 in Perspectives OCD, 3 in the Health and Well-Being Program group).
Duration of OCD
23.9 years since onset
STANDARD_DEVIATION 15.3 • n=60 Participants
26.5 years since onset
STANDARD_DEVIATION 16.4 • n=60 Participants
25.2 years since onset
STANDARD_DEVIATION 15.8 • n=120 Participants
Current psychiatric comorbidities
Major depression
9 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
8 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
17 Participants
n=120 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
Current psychiatric comorbidities
Panic disorder
9 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
1 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
10 Participants
n=120 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
Current psychiatric comorbidities
Agoraphobia
3 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
4 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
7 Participants
n=120 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
Current psychiatric comorbidities
Social anxiety disorder
7 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
10 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
17 Participants
n=120 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
Current psychiatric comorbidities
Alcohol use disorder
2 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
5 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
7 Participants
n=120 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
Current psychiatric comorbidities
Binge eating disorder
1 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
2 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
3 Participants
n=120 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
Current psychiatric comorbidities
Generalized anxiety disorder
8 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
11 Participants
n=59 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
19 Participants
n=119 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
Current psychiatric comorbidities
Body dysmorphic disorder
5 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
6 Participants
n=60 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
11 Participants
n=120 Participants • The diagnostic designation for generalized anxiety disorder was accidentally not assessed for one participant in the Health and Well-Being Program group.
Number of comorbid axis I disorders
None
36 Participants
n=60 Participants
33 Participants
n=60 Participants
69 Participants
n=120 Participants
Number of comorbid axis I disorders
1
12 Participants
n=60 Participants
11 Participants
n=60 Participants
23 Participants
n=120 Participants
Number of comorbid axis I disorders
2
6 Participants
n=60 Participants
12 Participants
n=60 Participants
18 Participants
n=120 Participants
Number of comorbid axis I disorders
3 or more
6 Participants
n=60 Participants
4 Participants
n=60 Participants
10 Participants
n=120 Participants
Current psychotropic medication
None
35 Participants
n=60 Participants
37 Participants
n=60 Participants
72 Participants
n=120 Participants
Current psychotropic medication
Selective reuptake inhibitor (SRI)
15 Participants
n=60 Participants
18 Participants
n=60 Participants
33 Participants
n=120 Participants
Current psychotropic medication
Non-SRI antidepressant
5 Participants
n=60 Participants
9 Participants
n=60 Participants
14 Participants
n=120 Participants
Current psychotropic medication
Benzodiazepine
6 Participants
n=60 Participants
1 Participants
n=60 Participants
7 Participants
n=120 Participants
Current psychotropic medication
Antipsychotic
1 Participants
n=60 Participants
0 Participants
n=60 Participants
1 Participants
n=120 Participants
Current psychotropic medication
Other psychotropic medication
10 Participants
n=60 Participants
13 Participants
n=60 Participants
23 Participants
n=120 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Perspectives OCD
n=60 Participants
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).
The Health and Well-Being Program
n=60 Participants
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.
Difference in OCD Symptom Severity at the End of Week 12
Week 0
25.12 score on a scale
Standard Deviation 4.22
23.77 score on a scale
Standard Deviation 4.60
Difference in OCD Symptom Severity at the End of Week 12
Week 6
18.68 score on a scale
Standard Deviation 5.34
20.49 score on a scale
Standard Deviation 5.32
Difference in OCD Symptom Severity at the End of Week 12
Week 12
16.14 score on a scale
Standard Deviation 6.48
18.15 score on a scale
Standard Deviation 5.67

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Perspectives OCD
n=60 Participants
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).
The Health and Well-Being Program
n=60 Participants
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.
Difference in Depression at the End of Week 12
Week 0
8.70 score on a scale
Standard Deviation 4.53
8.27 score on a scale
Standard Deviation 4.11
Difference in Depression at the End of Week 12
Week 6
7.23 score on a scale
Standard Deviation 5.10
7.00 score on a scale
Standard Deviation 4.20
Difference in Depression at the End of Week 12
Week 12
6.36 score on a scale
Standard Deviation 4.60
6.84 score on a scale
Standard Deviation 4.89

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
Perspectives OCD
n=60 Participants
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).
The Health and Well-Being Program
n=60 Participants
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.
Difference in Functional Impairment at the End of Week 12
Week 0
20.57 score on a scale
Standard Deviation 8.91
18.80 score on a scale
Standard Deviation 7.70
Difference in Functional Impairment at the End of Week 12
Week 6
16.04 score on a scale
Standard Deviation 9.07
16.43 score on a scale
Standard Deviation 10.84
Difference in Functional Impairment at the End of Week 12
Week 12
12.38 score on a scale
Standard Deviation 8.99
14.98 score on a scale
Standard Deviation 9.97

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure
Perspectives OCD
n=60 Participants
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).
The Health and Well-Being Program
n=60 Participants
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.
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
62.54 percentage of the scale maximum score
Standard Deviation 16.26
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
59.02 percentage of the scale maximum score
Standard Deviation 14.79
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
63.04 percentage of the scale maximum score
Standard Deviation 16.26

Adverse Events

Perspectives OCD

Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths

The Health and Well-Being Program

Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Perspectives OCD
n=60 participants at risk
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).
The Health and Well-Being Program
n=60 participants at risk
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.
Psychiatric disorders
Worsening of mental health resulting in inpatient hospitalization
1.7%
1/60 • Number of events 1 • 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.
0.00%
0/60 • 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.

Other adverse events

Other adverse events
Measure
Perspectives OCD
n=60 participants at risk
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).
The Health and Well-Being Program
n=60 participants at risk
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.
Gastrointestinal disorders
Gastrointestinal problems including diarrhea, norovirus, Crohn's disease, acid reflux
6.7%
4/60 • Number of events 5 • 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.
1.7%
1/60 • Number of events 1 • 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.
Infections and infestations
COVID-19 and/or flu
3.3%
2/60 • Number of events 2 • 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.
10.0%
6/60 • Number of events 6 • 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.
Musculoskeletal and connective tissue disorders
arthritis, leg/foot pain, muscle spasms, muscle tension, herniated disc, tendonitis
3.3%
2/60 • Number of events 2 • 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.
10.0%
6/60 • Number of events 6 • 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.
Psychiatric disorders
increased depression, anxiety, and/or irritability
8.3%
5/60 • Number of events 5 • 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.
10.0%
6/60 • Number of events 7 • 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.
Psychiatric disorders
worsening of OCD symptoms
3.3%
2/60 • Number of events 2 • 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.
6.7%
4/60 • Number of events 4 • 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.
Social circumstances
stress and anxiety due to job, relationships, death of a loved one, or household problems
16.7%
10/60 • Number of events 11 • 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.
11.7%
7/60 • Number of events 10 • 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.

Additional Information

Dr. Sabine Wilhelm, Chief of Psychology

Massachusetts General Hospital

Phone: 617-724-6146

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place