Trial Outcomes & Findings for Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment (NCT NCT04364191)
NCT ID: NCT04364191
Last Updated: 2024-05-29
Results Overview
time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
immediately post-intervention (4-5weeks after the start of the intervention)
Results posted on
2024-05-29
Participant Flow
Screened 180 participants
Participant milestones
| Measure |
Intervention Arm
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=13 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=14 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.93 years
STANDARD_DEVIATION 7.13 • n=5 Participants
|
65.31 years
STANDARD_DEVIATION 5.75 • n=7 Participants
|
65.63 years
STANDARD_DEVIATION 6.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
subjective sleep latency
|
41.42 minutes
STANDARD_DEVIATION 33.10 • n=5 Participants
|
46.57 minutes
STANDARD_DEVIATION 27.73 • n=7 Participants
|
44.09 minutes
STANDARD_DEVIATION 29.95 • n=5 Participants
|
|
subjective sleep efficiency
|
70 percentage
STANDARD_DEVIATION 12 • n=5 Participants
|
65 percentage
STANDARD_DEVIATION 11 • n=7 Participants
|
67.90 percentage
STANDARD_DEVIATION 11.94 • n=5 Participants
|
|
subjective total sleep time
|
346.27 minutes
STANDARD_DEVIATION 85.42 • n=5 Participants
|
336.00 minutes
STANDARD_DEVIATION 64.54 • n=7 Participants
|
341.14 minutes
STANDARD_DEVIATION 74.36 • n=5 Participants
|
|
subjective wake after sleep onset
|
44.85 minutes
STANDARD_DEVIATION 28.38 • n=5 Participants
|
46.30 minutes
STANDARD_DEVIATION 40.56 • n=7 Participants
|
45.63 minutes
STANDARD_DEVIATION 34.79 • n=5 Participants
|
|
36-Item Short Form Survey (SF-36)
|
59.23 units on a scale
STANDARD_DEVIATION 34.02 • n=5 Participants
|
58.93 units on a scale
STANDARD_DEVIATION 21.41 • n=7 Participants
|
59.07 units on a scale
STANDARD_DEVIATION 27.63 • n=5 Participants
|
|
Insomnia Severity Index
|
13.23 scores on a scale
STANDARD_DEVIATION 4.17 • n=5 Participants
|
14.5 scores on a scale
STANDARD_DEVIATION 4.80 • n=7 Participants
|
13.89 scores on a scale
STANDARD_DEVIATION 4.47 • n=5 Participants
|
|
Pittsburgh Sleep Quality Index
|
9.85 score on a scale
STANDARD_DEVIATION 2.61 • n=5 Participants
|
10.86 score on a scale
STANDARD_DEVIATION 2.63 • n=7 Participants
|
10.37 score on a scale
STANDARD_DEVIATION 2.62 • n=5 Participants
|
|
Number of Participants who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately post-intervention (4-5weeks after the start of the intervention)time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Sleep Latency
|
28.51 minutes
Standard Deviation 31.18
|
47.06 minutes
Standard Deviation 34.61
|
PRIMARY outcome
Timeframe: 3 months post interventionPopulation: Lost one participant in intervention to follow-up; lost two participants in control arm to follow up and one had missing sleep diary data at follow up
time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=11 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Sleep Latency
|
25.39 minutes
Standard Deviation 27.02
|
35.92 minutes
Standard Deviation 32.44
|
PRIMARY outcome
Timeframe: immediately post-intervention (4-5weeks after the start of the intervention)Population: lost one intervention participant and one control participant to immediate follow up
RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL.
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Health Related Quality of Life (HRQOL)
|
60.83 score on a scale
Standard Deviation 31.10
|
58.08 score on a scale
Standard Deviation 20.97
|
PRIMARY outcome
Timeframe: 3 months post interventionPopulation: Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control group.
RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL.
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=12 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Health Related Quality of Life (HRQOL)
|
55.83 score on a scale
Standard Deviation 29.99
|
54.58 score on a scale
Standard Deviation 22.71
|
SECONDARY outcome
Timeframe: immediately post intervention (4-5weeks after the start of the intervention)Population: lost one intervention participant and one control participant to immediate follow up
time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Wake After Sleep Onset (WASO)
|
29.57 minutes
Standard Deviation 33.70
|
37.25 minutes
Standard Deviation 32.49
|
SECONDARY outcome
Timeframe: 3 months post interventionPopulation: Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control group.
time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=12 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Wake After Sleep Onset (WASO)
|
29.30 minutes
Standard Deviation 33.06
|
35.21 minutes
Standard Deviation 43.57
|
SECONDARY outcome
Timeframe: immediately post interventionPopulation: lost one intervention participant and one control participant to immediate follow up
Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Total Sleep Time (TST)
|
368.78 minutes
Standard Deviation 90.03
|
361.43 minutes
Standard Deviation 70.86
|
SECONDARY outcome
Timeframe: 3 months post interventionPopulation: Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control
Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=12 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Total Sleep Time (TST)
|
381.38 minutes
Standard Deviation 70.46
|
340.38 minutes
Standard Deviation 90.11
|
SECONDARY outcome
Timeframe: immediately post interventionPopulation: lost one intervention participant and one control participant to immediate follow up
Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Sleep Efficiency (SE)
|
77 percentage of time asleep
Standard Deviation 12
|
68 percentage of time asleep
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 3 months post interventionPopulation: Lost one participant to immediate follow-up in intervention group and one to immediate follow-up in control and one at 3 mo follow up in control group.
Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=12 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Sleep Efficiency (SE)
|
77 percentage of time spent asleep
Standard Deviation 13
|
66 percentage of time spent asleep
Standard Deviation 17
|
SECONDARY outcome
Timeframe: immediately post interventionmeasured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Self- Reported Insomnia Symptoms
|
12 score on a scale
Standard Deviation 10.67
|
12.5 score on a scale
Standard Deviation 4.75
|
SECONDARY outcome
Timeframe: 3 months post interventionmeasured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=12 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Self- Reported Insomnia Symptoms
|
9.42 score on a scale
Standard Deviation 4.21
|
11.83 score on a scale
Standard Deviation 4.86
|
SECONDARY outcome
Timeframe: immediately post interventionmeasured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Self-reported Sleep Quality
|
8.83 score on a scale
Standard Deviation 2.68
|
10.29 score on a scale
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: 3 months post interventionmeasured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=12 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Self-reported Sleep Quality
|
8.5 score on a scale
Standard Deviation 2.68
|
10.17 score on a scale
Standard Deviation 1.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately post interventionSystemic inflammatory markers will be assayed using dried blood spots (DBS). DBS provides an easy to obtain, transport, and analyze blood source. Our Translational Core Laboratory utilizes a matrix independent platform (Mesoscale Discovery, Rockville MD), to support the assay of DBS for systemic inflammatory markers. Participants who have trouble with the finger prick will be provided with verbal assistance at sample pick-up while the researcher maintains physical distance. The outcome measure used for this study will be number of participants who complete the dried blood spot sample, as a measure of feasibility.
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis
|
10 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months post interventionSystemic inflammatory markers will be assayed using dried blood spots (DBS). DBS provides an easy to obtain, transport, and analyze blood source. Our Translational Core Laboratory utilizes a matrix independent platform (Mesoscale Discovery, Rockville MD), to support the assay of DBS for systemic inflammatory markers. Participants who have trouble with the finger prick will be provided with verbal assistance at sample pick-up while the researcher maintains physical distance.
Outcome measures
| Measure |
Intervention Arm
n=12 Participants
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Multicomponent Behavioral Sleep Intervention for Insomnia: The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
|
Control Arm
n=13 Participants
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Active Control: The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
|
|---|---|---|
|
Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis
|
8 Participants
|
6 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Arm
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