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.
COMPLETED
NA
120 participants
Baseline (week 0), mid-treatment (week 6), end-of-treatment (week 12)
2024-11-25
Participant Flow
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
| 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
| 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
| 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
| 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 12Population: 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
| 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 12Population: 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
| 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
The Health and Well-Being Program
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place