Trial Outcomes & Findings for Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness (NCT NCT02035202)
NCT ID: NCT02035202
Last Updated: 2019-08-13
Results Overview
The BPRS-24 includes 24 items that cover depression, anxiety, mania, suicidality, delusions/hallucinations, and unusual behavior. The BPRS is reliable, valid, and sensitive to change in both bipolar disorder and schizophrenia, and therefore enables the examination of diagnosis as a moderator of treatment effect. Twenty four items are rated on a 1-7 scale from present to severe, and the Total Score will be the primary outcome for analyses. It is clinician rated and the minimum score is 24 and the maximum score is 148 and higher scores reflect worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
255 participants
Primary outcome timeframe
Baseline, 6 weeks, 12 weeks, and 24 weeks
Results posted on
2019-08-13
Participant Flow
Participant milestones
| Measure |
CBT2go
Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.
CBT2go: CBT administered using mobile intervention.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
EMA-only
Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
Standard Care
Participants assigned to this condition will only participate in the assessments.
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
85
|
|
Overall Study
COMPLETED
|
77
|
69
|
83
|
|
Overall Study
NOT COMPLETED
|
8
|
16
|
2
|
Reasons for withdrawal
| Measure |
CBT2go
Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.
CBT2go: CBT administered using mobile intervention.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
EMA-only
Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
Standard Care
Participants assigned to this condition will only participate in the assessments.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
16
|
2
|
Baseline Characteristics
Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness
Baseline characteristics by cohort
| Measure |
CBT2go
n=77 Participants
Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.
CBT2go: CBT administered using mobile intervention.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
EMA-only
n=69 Participants
Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
Standard Care
n=83 Participants
Participants assigned to this condition will only participate in the assessments.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
51.2 YEARS
STANDARD_DEVIATION 11.5 • n=5 Participants
|
49.4 YEARS
STANDARD_DEVIATION 11.1 • n=7 Participants
|
48.1 YEARS
STANDARD_DEVIATION 11.7 • n=5 Participants
|
49.3 YEARS
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
77 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
|
Brief Psychiatric Rating Scale TOTAL
|
43.2 units on a scale
STANDARD_DEVIATION 9.7 • n=5 Participants
|
41.6 units on a scale
STANDARD_DEVIATION 11.5 • n=7 Participants
|
42.0 units on a scale
STANDARD_DEVIATION 10.9 • n=5 Participants
|
42.3 units on a scale
STANDARD_DEVIATION 10.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks, and 24 weeksThe BPRS-24 includes 24 items that cover depression, anxiety, mania, suicidality, delusions/hallucinations, and unusual behavior. The BPRS is reliable, valid, and sensitive to change in both bipolar disorder and schizophrenia, and therefore enables the examination of diagnosis as a moderator of treatment effect. Twenty four items are rated on a 1-7 scale from present to severe, and the Total Score will be the primary outcome for analyses. It is clinician rated and the minimum score is 24 and the maximum score is 148 and higher scores reflect worse outcome.
Outcome measures
| Measure |
CBT2go
n=77 Participants
Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.
CBT2go: CBT administered using mobile intervention.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
EMA-only
n=69 Participants
Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
Standard Care
n=83 Participants
Participants assigned to this condition will only participate in the assessments.
|
|---|---|---|---|
|
Score on the Brief Psychiatric Rating Scale (BPRS)
6 weeks
|
41.0 units on a scale
Standard Deviation 11.1
|
39.6 units on a scale
Standard Deviation 7.7
|
41.0 units on a scale
Standard Deviation 11.3
|
|
Score on the Brief Psychiatric Rating Scale (BPRS)
Baseline
|
43.2 units on a scale
Standard Deviation 9.7
|
41.6 units on a scale
Standard Deviation 11.5
|
42.0 units on a scale
Standard Deviation 10.9
|
|
Score on the Brief Psychiatric Rating Scale (BPRS)
12 weeks
|
39.7 units on a scale
Standard Deviation 11.9
|
38.6 units on a scale
Standard Deviation 9.1
|
41.0 units on a scale
Standard Deviation 11.4
|
|
Score on the Brief Psychiatric Rating Scale (BPRS)
24 Weeks
|
39.7 units on a scale
Standard Deviation 11.9
|
37.6 units on a scale
Standard Deviation 10.1
|
41.1 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: There was missing data due to lack of available informants for the SLOF so that the number analyzed is less than that associated with the other measures
The SLOF is an interviewer rated measure that addresses community function in serious mental illness, utilizing a best estimate approach in which data is integrated from interviewer, informant, and participant responses. The score ranges from 30 to 150. Higher scores equal greater function.
Outcome measures
| Measure |
CBT2go
n=71 Participants
Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.
CBT2go: CBT administered using mobile intervention.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
EMA-only
n=61 Participants
Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
Standard Care
n=73 Participants
Participants assigned to this condition will only participate in the assessments.
|
|---|---|---|---|
|
SPECIFIC LEVEL OF FUNCTION (SLOF)
Baseline
|
126.9 units on a scale
Standard Deviation 15.2
|
128.4 units on a scale
Standard Deviation 15.51
|
126.9 units on a scale
Standard Deviation 16.1
|
|
SPECIFIC LEVEL OF FUNCTION (SLOF)
12 weeks
|
129.1 units on a scale
Standard Deviation 15.8
|
127.8 units on a scale
Standard Deviation 16.1
|
123.4 units on a scale
Standard Deviation 15.8
|
|
SPECIFIC LEVEL OF FUNCTION (SLOF)
24 Weeks
|
130.0 units on a scale
Standard Deviation 16.9
|
128.7 units on a scale
Standard Deviation 16.3
|
123.3 units on a scale
Standard Deviation 18.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, mid-point (6 weeks), at post-treatment (12 weeks), 24 week follow upThe DAS is a 40-item self-report subscale indexing maladaptive attitudes, particularly one's ability to perform tasks and one's need for approval from others. The DAS consists of 40 items and each item consists of a statement and each is rated on a 7-point Likert scale (7 = fully agree; 1 = fully disagree). Ten items are reverse coded (items: 2, 6, 12, 17, 24, 29, 30, 35, 37 and 40). The total score is the sum of the 40-items and the range of scores is 40-280, with higher scores indicating more dysfunctional attitudes.
Outcome measures
| Measure |
CBT2go
n=75 Participants
Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.
CBT2go: CBT administered using mobile intervention.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
EMA-only
n=62 Participants
Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
Standard Care
n=74 Participants
Participants assigned to this condition will only participate in the assessments.
|
|---|---|---|---|
|
Dysfunctional Attitudes Scale (DAS)
Baseline
|
49.9 units on a scale
Standard Deviation 18.8
|
49.9 units on a scale
Standard Deviation 18.2
|
49.3 units on a scale
Standard Deviation 17.8
|
|
Dysfunctional Attitudes Scale (DAS)
6 weels
|
47.8 units on a scale
Standard Deviation 19.0
|
49.9 units on a scale
Standard Deviation 18.0
|
49.6 units on a scale
Standard Deviation 15.4
|
|
Dysfunctional Attitudes Scale (DAS)
12 weeks
|
47.0 units on a scale
Standard Deviation 18.3
|
46.0 units on a scale
Standard Deviation 17.4
|
51.3 units on a scale
Standard Deviation 18.9
|
|
Dysfunctional Attitudes Scale (DAS)
24 weeks
|
45.2 units on a scale
Standard Deviation 19.0
|
48.0 units on a scale
Standard Deviation 19
|
48.6 units on a scale
Standard Deviation 16.4
|
Adverse Events
CBT2go
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
EMA-only
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBT2go
n=85 participants at risk
Participants assigned to this condition will attend one session with a therapist to identify cognitive and behavioral strategies around four areas: 1) mood/psychotic symptoms, 2) medication adherence, 3) socialization, and 4) relapse prevention. Subsequently they will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks, and they will receive personalized cognitive and behavioral strategies linked to their momentary responses with bi-monthly telephone support.
CBT2go: CBT administered using mobile intervention.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
EMA-only
n=85 participants at risk
Participants assigned to this condition will answer questions on a mobile device (smartphone) 3 times per day for 12 weeks but will not receive personalized cognitive and behavioral strategies.
Smartphone: A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
|
Standard Care
n=85 participants at risk
Participants assigned to this condition will only participate in the assessments.
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization
|
11.8%
10/85 • Number of events 10 • 6 months
Adverse event: Any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Serious Adverse Event: Any AE that results in any of the following outcomes: * Death * Life-threatening event requiring inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity
|
14.1%
12/85 • Number of events 12 • 6 months
Adverse event: Any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Serious Adverse Event: Any AE that results in any of the following outcomes: * Death * Life-threatening event requiring inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity
|
10.6%
9/85 • Number of events 9 • 6 months
Adverse event: Any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Serious Adverse Event: Any AE that results in any of the following outcomes: * Death * Life-threatening event requiring inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place