Trial Outcomes & Findings for Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use (NCT NCT03689179)
NCT ID: NCT03689179
Last Updated: 2024-10-15
Results Overview
Anxiety was measured with the PROMIS Anxiety short-form questionnaire for adults, a self-report, 8-item additive scale that standardizes the distribution of anxiety-related symptoms (T-score) on a population-distribution with a mean of 50 and standard deviation of 10: "During the past 7 days, I felt nervous, anxious, fearful, uneasy, tense, worried, unable to focus on anything other than my anxiety, felt like I needed help with my anxiety" each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
166 participants
Primary outcome timeframe
Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Treatment With Follow-up (Group A)
Group A received access to the full "Time for Living \& Caring" (TLC) intervention for 8 weeks (calendar + coaching + resources), followed by an 8-week maintenance period where they could continue to use the TLC intervention. The TLC intervention turned off after 16 weeks of exposure for all participants.
|
Wait-List Control (Group B)
Group B received 8 weeks of waitlist control (minimal treatment - calendar only) , followed by access to the full "Time for Living \& Caring" (TLC) intervention for an additional 8 weeks (calendar + coaching + resources). The TLC intervention turned off after 16 weeks of exposure for all participants.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
83
|
|
Overall Study
COMPLETED
|
69
|
67
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use
Baseline characteristics by cohort
| Measure |
Treatment With Follow-up (Group A)
n=83 Participants
Group A received access to the full "Time for Living \& Caring" (TLC) intervention for 8 weeks (calendar + coaching + resources), followed by an 8-week maintenance period where they could continue to use the TLC intervention. The TLC intervention turned off after 16 weeks of exposure for all participants.
|
Waitlist Control (Group A)
n=83 Participants
Group B received 8 weeks of waitlist control (minimal treatment - calendar only) , followed by access to the full "Time for Living \& Caring" (TLC) intervention for an additional 8 weeks (calendar + coaching + resources). The TLC intervention turned off after 16 weeks of exposure for all participants.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
61.7 years
STANDARD_DEVIATION 13.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
137 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=99 Participants
|
83 participants
n=107 Participants
|
166 participants
n=206 Participants
|
|
Marital Status
Married
|
65 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Marital Status
Divorced
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Marital Status
Living with Partner
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Marital Status
Never Married
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Marital Status
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Education Completed
Some High School
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Education Completed
High School Graduate
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Education Completed
Some College, Associates Degree, and/or Vocational or Technical School
|
33 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Education Completed
College or University Degree
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Education Completed
Postgraduate or Professional Degree
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Education Completed
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Annual Income
$10,000 to $19,999
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Annual Income
$20,000 to $29,999
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Annual Income
$30,000 to $39,999
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Annual Income
$40,000 to $49,999
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Annual Income
$50,000 to $59,999
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Annual Income
$60,000 to $69,999
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Annual Income
$70,000 to $79,999
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Annual Income
$80,000 to $89,999
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Annual Income
$90,000 to $99,999
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Annual Income
$100,000 to $149,999
|
17 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Annual Income
$150,000 or more
|
4 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Annual Income
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group BPopulation: Three enrolled participants were excluded from this analysis due to missing baseline data (i.e., 163 person out of 166 enrolled have data).If a participant was missing more than 30% of the items (i.e., 2 or more items on the anxiety questionnaire), the scale score was coded as missing. Under these criteria, the full TLC sample has a calculated score for anxiety.
Anxiety was measured with the PROMIS Anxiety short-form questionnaire for adults, a self-report, 8-item additive scale that standardizes the distribution of anxiety-related symptoms (T-score) on a population-distribution with a mean of 50 and standard deviation of 10: "During the past 7 days, I felt nervous, anxious, fearful, uneasy, tense, worried, unable to focus on anything other than my anxiety, felt like I needed help with my anxiety" each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of anxiety.
Outcome measures
| Measure |
Treatment With Follow-up (Group A)
n=83 Participants
Group A will receive access to the full "Time for Living \& Caring" (TLC) intervention for 16 weeks, with a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
Wait-List / Control Treatment With Follow-up (Group B)
n=80 Participants
After the initial 8-week orientation period where Group B will receive 8 weeks of waitlist (limited treatment) control, followed by full access to the "Time for Living \& Caring" (TLC) intervention for 8 weeks. They will also receive a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
|---|---|---|
|
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
T0 - baseline, Pre-Intervention
|
55.51 T-score
Interval 53.48 to 57.53
|
53.93 T-score
Interval 51.95 to 55.9
|
|
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
T4
|
56.75 T-score
Interval 54.65 to 58.86
|
57.35 T-score
Interval 55.5 to 59.21
|
|
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
T8
|
56.39 T-score
Interval 54.38 to 58.4
|
56.99 T-score
Interval 55.38 to 58.59
|
|
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
T12
|
56.92 T-score
Interval 54.76 to 59.09
|
54.20 T-score
Interval 52.53 to 55.86
|
|
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
T16 - Post Intervention
|
56.54 T-score
Interval 54.24 to 58.85
|
52.75 T-score
Interval 50.75 to 54.75
|
|
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
T20 - Follow-up
|
58.15 T-score
Interval 55.79 to 60.52
|
55.73 T-score
Interval 53.69 to 57.77
|
PRIMARY outcome
Timeframe: Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group BPopulation: Three enrolled participants were excluded from analysis due to missing baseline data.
Self-report multi-item index (24 items; range 0-96). Lower scores indicate lower levels of caregiver burden. Higher scores indicate higher levels of perceived burden associated with caregiving tasks.
Outcome measures
| Measure |
Treatment With Follow-up (Group A)
n=83 Participants
Group A will receive access to the full "Time for Living \& Caring" (TLC) intervention for 16 weeks, with a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
Wait-List / Control Treatment With Follow-up (Group B)
n=80 Participants
After the initial 8-week orientation period where Group B will receive 8 weeks of waitlist (limited treatment) control, followed by full access to the "Time for Living \& Caring" (TLC) intervention for 8 weeks. They will also receive a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
|---|---|---|
|
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
T0 - Baseline
|
45.94 score on a scale
Interval 42.22 to 49.65
|
46.10 score on a scale
Interval 42.4 to 49.79
|
|
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
T4
|
45.33 score on a scale
Interval 41.39 to 49.27
|
43.22 score on a scale
Interval 40.5 to 45.95
|
|
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
T8 - mid intervention
|
45.02 score on a scale
Interval 41.37 to 48.66
|
43.37 score on a scale
Interval 40.16 to 46.58
|
|
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
T12
|
45.72 score on a scale
Interval 41.66 to 49.78
|
40.80 score on a scale
Interval 37.65 to 43.94
|
|
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
T16 - Post intervention
|
49.91 score on a scale
Interval 45.57 to 54.26
|
42.05 score on a scale
Interval 38.31 to 45.79
|
|
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
T20 - follow up
|
50.09 score on a scale
Interval 45.47 to 54.71
|
43.23 score on a scale
Interval 40.01 to 46.46
|
SECONDARY outcome
Timeframe: Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group BPopulation: Three enrolled participants were excluded from this analysis due to missing baseline data.
Participants were asked to self-report number of hours they typically receive respite in a typical week. The following survey question and description were asked to all participants "On average, how many hours of respite do you get in a typical week? These would be hours that you can completely turn-off your caregiving responsibilities, while the needs and safety of your family member are not your primary responsibility."
Outcome measures
| Measure |
Treatment With Follow-up (Group A)
n=83 Participants
Group A will receive access to the full "Time for Living \& Caring" (TLC) intervention for 16 weeks, with a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
Wait-List / Control Treatment With Follow-up (Group B)
n=80 Participants
After the initial 8-week orientation period where Group B will receive 8 weeks of waitlist (limited treatment) control, followed by full access to the "Time for Living \& Caring" (TLC) intervention for 8 weeks. They will also receive a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
|---|---|---|
|
Respite Time-Use (in Hours Per Week)
Pre Intervention
|
8.77 number of hours (self-reported)
Standard Deviation 8.89
|
7.81 number of hours (self-reported)
Standard Deviation 11.01
|
|
Respite Time-Use (in Hours Per Week)
Post Intervention
|
13.44 number of hours (self-reported)
Standard Deviation 12.64
|
13.11 number of hours (self-reported)
Standard Deviation 10.82
|
SECONDARY outcome
Timeframe: Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group BPopulation: Three enrolled participants were excluded from this analysis due to missing baseline data.
Self-report single item measure, assessing partcipants' perceived level of satisfaction with their respite time and time use. Respondents were asked about their level of agreement with the following statement: "I am happy with what I choose to do during my respite time". Responses were recorded on a five-point Likert scale with strongly disagree=1 and strongly agree 5. This variable is dichotomized, showing the count (and percentage) of the sample that responded with "agree" or "stongly agree." This self-report assessment was only collected at baseline (pre-intervention) and at time 16 (post-intervention)
Outcome measures
| Measure |
Treatment With Follow-up (Group A)
n=83 Participants
Group A will receive access to the full "Time for Living \& Caring" (TLC) intervention for 16 weeks, with a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
Wait-List / Control Treatment With Follow-up (Group B)
n=80 Participants
After the initial 8-week orientation period where Group B will receive 8 weeks of waitlist (limited treatment) control, followed by full access to the "Time for Living \& Caring" (TLC) intervention for 8 weeks. They will also receive a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
|---|---|---|
|
Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement "I am Happy With What I Choose to do During Respite"
Pre Intervention (baseline, week 1)
|
38 Participants
|
34 Participants
|
|
Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement "I am Happy With What I Choose to do During Respite"
Post Intervention (week 16)
|
61 Participants
|
59 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group BPopulation: Three enrolled participants were excluded from this analysis due to missing baseline data. If a participant was missing more than 30% of the items (i.e., 2 or more items on the depression questionnaire), the scale score was coded as missing. Under these criteria, the full TLC sample has a calculated score for depression.
Self-report multi-item index (8-items, additive), with higher scores indicating greater presence and frequency of depressive symptoms; scores are standardized to a distribution of depression-related symptoms on a population-distribution with a mean of 50 and standard deviation of 10 (T-score). Participants self-reported to the following survey questions: "During the past 7 days, I felt worthless, helpless, depressed, hopeless, like a failure, unhappy, that I had nothing to look forward to, that nothing could cheer me up," each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of depressive symptoms.
Outcome measures
| Measure |
Treatment With Follow-up (Group A)
n=83 Participants
Group A will receive access to the full "Time for Living \& Caring" (TLC) intervention for 16 weeks, with a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
Wait-List / Control Treatment With Follow-up (Group B)
n=80 Participants
After the initial 8-week orientation period where Group B will receive 8 weeks of waitlist (limited treatment) control, followed by full access to the "Time for Living \& Caring" (TLC) intervention for 8 weeks. They will also receive a 4-week follow-up at Week 20 of the study.
Time for Living and Caring (TLC): "Time for Living \& Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: a "virtual coaching" module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.
|
|---|---|---|
|
Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"
T0 - preintervention
|
54.34 T-score
Interval 52.76 to 55.92
|
53.92 T-score
Interval 52.22 to 55.61
|
|
Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"
T4
|
55.81 T-score
Interval 54.21 to 57.41
|
55.18 T-score
Interval 53.61 to 56.74
|
|
Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"
T8 - mid intervention
|
54.68 T-score
Interval 52.81 to 56.55
|
54.38 T-score
Interval 52.76 to 56.0
|
|
Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"
T12
|
55.73 T-score
Interval 53.88 to 57.58
|
53.19 T-score
Interval 51.75 to 54.63
|
|
Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"
T16 - post-intervention
|
54.75 T-score
Interval 52.86 to 56.64
|
52.52 T-score
Interval 50.65 to 54.39
|
|
Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"
T20 - follow-up
|
56.25 T-score
Interval 54.43 to 58.05
|
53.85 T-score
Interval 52.08 to 55.62
|
Adverse Events
Treatment With Follow-up (Group A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Wait-List Control w/Treatment (Group B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place