Trial Outcomes & Findings for Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being (NCT NCT03506945)
NCT ID: NCT03506945
Last Updated: 2025-10-24
Results Overview
20 item scale measuring Depressive Symptoms. Each item rated on a range of 0-4 and items are summed to create a total score (Range = 0-80). Higher scores denote greater depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
15-months
Results posted on
2025-10-24
Participant Flow
Recruitment centered on community providers and research organizations serving caregivers and persons with dementia, as well as community-based caregiver support groups. Further recruitment occurred via digital and print advertisement.
Participant milestones
| Measure |
Mobile Pleasant Events Program (mPEP)
This arm consists of 12 weeks of behavioral activation therapy delivered via smart phone or smart device (e.g., iPAD).
|
Psychoeducation
This arm consists of 12 weeks of digital psychoeducation consisting of a comprehensive resource guide containing materials on coping with specific caregiver stresses (e.g., developing problem-solving skills; managing care receiver problem behaviors; improving communication).
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
91
|
|
Overall Study
COMPLETED
|
63
|
52
|
|
Overall Study
NOT COMPLETED
|
30
|
39
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
Baseline characteristics by cohort
| Measure |
Mobile Pleasant Events Program (mPEP)
n=93 Participants
This arm consists of 12 weeks of behavioral activation therapy delivered via smart phone or smart device (e.g., iPAD).
|
Psychoeducation
n=91 Participants
This arm consists of 12 weeks of digital psychoeducation consisting of a comprehensive resource guide containing materials on coping with specific caregiver stresses (e.g., developing problem-solving skills; managing care receiver problem behaviors; improving communication).
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
63.8 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Center For Epidemiologic Studies Depression Scale - Revised (CESD-R)
|
19.7 Scores on a Scale
STANDARD_DEVIATION 13.7 • n=5 Participants
|
19.0 Scores on a Scale
STANDARD_DEVIATION 13.2 • n=7 Participants
|
19.4 Scores on a Scale
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Positive Affect
|
28.4 Scores on a Scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
28.4 Scores on a Scale
STANDARD_DEVIATION 6.3 • n=7 Participants
|
28.4 Scores on a Scale
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Negative Affect
|
22.7 Scores on a Scale
STANDARD_DEVIATION 7.5 • n=5 Participants
|
22.1 Scores on a Scale
STANDARD_DEVIATION 6.4 • n=7 Participants
|
22.4 Scores on a Scale
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Quality of Life
|
60.2 Scores on a Scale
STANDARD_DEVIATION 12.4 • n=5 Participants
|
60.3 Scores on a Scale
STANDARD_DEVIATION 11.9 • n=7 Participants
|
60.2 Scores on a Scale
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Systolic Blood Pressure
|
124.8 mmHg
STANDARD_DEVIATION 17.8 • n=5 Participants
|
122.4 mmHg
STANDARD_DEVIATION 17.8 • n=7 Participants
|
123.7 mmHg
STANDARD_DEVIATION 17.8 • n=5 Participants
|
|
Diastolic Blood Pressure
|
78.9 mmHg
STANDARD_DEVIATION 7.8 • n=5 Participants
|
75.8 mmHg
STANDARD_DEVIATION 10.1 • n=7 Participants
|
77.4 mmHg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 15-monthsPopulation: Participants in each group dropped out or were lost to follow-up
20 item scale measuring Depressive Symptoms. Each item rated on a range of 0-4 and items are summed to create a total score (Range = 0-80). Higher scores denote greater depressive symptoms.
Outcome measures
| Measure |
mPEP
n=63 Participants
Behavioral Activation Therapy - Increase engagement in pleasant activities as a mechanism for reducing distress and improving overall well-being. Participants will use an online web tool to select and schedule activities they deem will be rewarding and fulfilling. They will then track their engagement in these activities on a weekly basis.
|
Bibliotherapy
n=52 Participants
Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems.
|
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale--Revised (CESD-R)
|
16.9 Score on a scale
Standard Error 1.6
|
14.9 Score on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 15-monthsPositive and Negative Affect Scale (PANAS). There are 10 items asking about Positive Affect, each item is rated on a range of 1-5. All 10 items are summed to create a total score (Range = 10-50) There are 10 items asking about Negative Affect, each item is rated from 1-5, and items are summed to create an overall score (Range = 10-50). Higher scores denote greater positive and negative affect, respectively.
Outcome measures
| Measure |
mPEP
n=63 Participants
Behavioral Activation Therapy - Increase engagement in pleasant activities as a mechanism for reducing distress and improving overall well-being. Participants will use an online web tool to select and schedule activities they deem will be rewarding and fulfilling. They will then track their engagement in these activities on a weekly basis.
|
Bibliotherapy
n=52 Participants
Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems.
|
|---|---|---|
|
Positive and Negative Affect Scale (PANAS)
Positive Affect
|
30.0 Scores on a scale
Standard Error 0.97
|
29.8 Scores on a scale
Standard Error 0.98
|
|
Positive and Negative Affect Scale (PANAS)
Negative Affect
|
20.4 Scores on a scale
Standard Error 0.95
|
19.5 Scores on a scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: 15-monthsSystolic and Diastolic Blood Pressure
Outcome measures
| Measure |
mPEP
n=63 Participants
Behavioral Activation Therapy - Increase engagement in pleasant activities as a mechanism for reducing distress and improving overall well-being. Participants will use an online web tool to select and schedule activities they deem will be rewarding and fulfilling. They will then track their engagement in these activities on a weekly basis.
|
Bibliotherapy
n=52 Participants
Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems.
|
|---|---|---|
|
Blood Pressure
Systolic Blood Pressure
|
123.4 mmHg
Standard Error 2.1
|
121.3 mmHg
Standard Error 1.9
|
|
Blood Pressure
Diastolic Blood Pressure
|
75.8 mmHg
Standard Error 1.2
|
76.0 mmHg
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 15-monthsPopulation: Participant withdrawal and lost to follow-up
Dementia Quality of Life Scale for Older Family Carers (DQoLOC). Scale consists of 22 items, each item is rated from 1-5. The total range for the scale is 22-110, with higher score indicating greater quality of life.
Outcome measures
| Measure |
mPEP
n=63 Participants
Behavioral Activation Therapy - Increase engagement in pleasant activities as a mechanism for reducing distress and improving overall well-being. Participants will use an online web tool to select and schedule activities they deem will be rewarding and fulfilling. They will then track their engagement in these activities on a weekly basis.
|
Bibliotherapy
n=52 Participants
Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems.
|
|---|---|---|
|
Dementia Quality of Life Scale for Older Family Carers (DQoLOC)
|
63.5 Score on a scale
Standard Error 1.9
|
64.8 Score on a scale
Standard Error 2.0
|
Adverse Events
mPEP
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Bibliotherapy
Serious events: 0 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
mPEP
n=93 participants at risk
Behavioral Activation Therapy - Increase engagement in pleasant activities as a mechanism for reducing distress and improving overall well-being. Participants will use an online web tool to select and schedule activities they deem will be rewarding and fulfilling. They will then track their engagement in these activities on a weekly basis.
|
Bibliotherapy
n=91 participants at risk
Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems.
|
|---|---|---|
|
General disorders
Progression of Dementia
|
12.9%
12/93 • From enrollment until 15 months
Clinical Trials definitions
|
14.3%
13/91 • From enrollment until 15 months
Clinical Trials definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place