Trial Outcomes & Findings for Mindfulness and CBT for Sleep (NCT NCT04736056)
NCT ID: NCT04736056
Last Updated: 2024-12-02
Results Overview
Treatment feasibility will be indicated by meeting target study accrual (i.e., 30 participants consented and enrolled for single-arm pilot).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
12 weeks (post-intervention)
Results posted on
2024-12-02
Participant Flow
Participant milestones
| Measure |
Phase 1 Part 1: Focus Group Patients (Months 0-6)
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress. Patients completed a one-time, 60-minute, telehealth focus group to share about their symptoms and impressions of the proposed intervention protocol.
|
Phase 1 Part 1: Focus Group Providers (Months 0-6)
Hematology-oncology providers caring for patients with hematologic cancer. Providers completed a one-time, 60-minute, telehealth focus group to share about common hematologic cancer symptoms and their impressions of the proposed intervention protocol.
|
Phase 1 Part 2: Patient User Testing (Months 6-12)
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in user testing of the proposed intervention protocol prior to the single-arm pilot.
Intervention:
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
Phase 2: Single-Arm Pilot (Months 12-23)
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
5
|
32
|
|
Overall Study
COMPLETED
|
10
|
6
|
3
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Phase 1 Part 1: Focus Group Patients (Months 0-6)
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress. Patients completed a one-time, 60-minute, telehealth focus group to share about their symptoms and impressions of the proposed intervention protocol.
|
Phase 1 Part 1: Focus Group Providers (Months 0-6)
Hematology-oncology providers caring for patients with hematologic cancer. Providers completed a one-time, 60-minute, telehealth focus group to share about common hematologic cancer symptoms and their impressions of the proposed intervention protocol.
|
Phase 1 Part 2: Patient User Testing (Months 6-12)
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in user testing of the proposed intervention protocol prior to the single-arm pilot.
Intervention:
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
Phase 2: Single-Arm Pilot (Months 12-23)
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Mindfulness and CBT for Sleep
Baseline characteristics by cohort
| Measure |
Phase 1 Part 1: Focus Group Patients (Months 0-6)
n=14 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress. Patients completed a one-time, 60-minute, telehealth focus group to share about their symptoms and impressions of the proposed intervention protocol.
|
Phase 1 Part 1: Focus Group Providers (Months 0-6)
n=6 Participants
Hematology-oncology providers caring for patients with hematologic cancer. Providers completed a one-time, 60-minute, telehealth focus group to share about common hematologic cancer symptoms and their impressions of the proposed intervention protocol.
|
Phase 1 Part 2: Patient User Testing (Months 6-12)
n=5 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in user testing of the proposed intervention protocol prior to the single-arm pilot.
Intervention:
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
Phase 2: Single-Arm Pilot (Months 12-23)
n=32 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.86 years
STANDARD_DEVIATION 15.85 • n=5 Participants
|
36.00 years
STANDARD_DEVIATION 10.83 • n=7 Participants
|
36.00 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
50.75 years
STANDARD_DEVIATION 19.64 • n=4 Participants
|
49.39 years
STANDARD_DEVIATION 17.35 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Ethnicity (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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (post-intervention)Population: Individuals who completed phone screening. Only applicable to Phase 2 participants.
Treatment feasibility will be indicated by meeting target study accrual (i.e., 30 participants consented and enrolled for single-arm pilot).
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=79 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot
|
32 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Treatment feasibility will be indicated by less than or equal to 20% study attrition at post-intervention follow-up.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Feasibility as Measured by Study Attrition at Post-intervention Follow-up
|
8.10 percentage of attrition
|
PRIMARY outcome
Timeframe: 12 weeks (post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Adherence will be indicated by at least 80% of the participants completing all 6 intervention sessions.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Feasibility as Measured by Adherence to the Intervention
|
83.80 percentage of participants
|
PRIMARY outcome
Timeframe: 12 weeks (post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants) who completed the intervention protocol.
Acceptability will be indicated by at least 80% of participants who completed the intervention protocol reporting satisfaction with the protocol on the CSQ (i.e., mean of at least 3 out of 4). The CSQ is a 10 item self-report measure with item responses ranging from 1 to 4, with higher scores indicating greater satisfaction. All 10 items were averaged to obtain a mean score (range: 1 - 4). The number of participants with a mean CSQ score of at least 3 out of 4 was tabulated and then converted to a percentage of patients.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=31 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
|
29 Participants
|
PRIMARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants that consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Scores on the ISI range from 0 to 28 with higher scores indicating more severe insomnia symptoms.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)
0 weeks
|
13.45 score on a scale
Standard Deviation 6.19
|
|
Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)
12 weeks
|
6.26 score on a scale
Standard Deviation 4.46
|
|
Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)
16 weeks
|
6.07 score on a scale
Standard Deviation 3.99
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Fatigue symptoms will be assessed using the 11-item Fatigue Symptom Inventory (FSI). Four items measure fatigue severity. Seven items measure fatigue interference. Scores on the FSI for fatigue severity and interference range from 0 to 10 with higher scores indicating higher fatigue severity and interference.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
0 weeks
|
4.48 score on a scale
Standard Deviation 1.97
|
|
Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
12 weeks
|
3.69 score on a scale
Standard Deviation 2.03
|
|
Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
16 weeks
|
4.06 score on a scale
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Fatigue symptoms will be assessed using the 11-item Fatigue Symptom Inventory (FSI). Four items measure fatigue severity. Seven items measure fatigue interference. Scores on the FSI for fatigue severity and interference range from 0 to 10 with higher scores indicating higher fatigue severity and interference.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)
0 weeks
|
4.18 score on a scale
Standard Deviation 2.49
|
|
Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)
12 weeks
|
2.70 score on a scale
Standard Deviation 2.55
|
|
Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)
16 weeks
|
3.09 score on a scale
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Pain symptoms will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF). Four items measure pain severity. Scores on the BPI-SF for pain severity range from 0 to 10 with higher scores indicating higher pain severity.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
0 weeks
|
2.59 score on a scale
Standard Deviation 2.19
|
|
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
12 weeks
|
2.13 score on a scale
Standard Deviation 2.01
|
|
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
16 weeks
|
1.79 score on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Pain symptoms will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF). Seven items measure pain interference. Scores on the BPI-SF for pain interference range from 0 to 10 with higher scores indicating higher pain interference.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
0 weeks
|
3.35 score on a scale
Standard Deviation 3.18
|
|
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
12 weeks
|
2.57 score on a scale
Standard Deviation 2.87
|
|
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
16 weeks
|
1.85 score on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Anxiety symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS). Seven items measure severity of anxiety symptoms. Scores for anxiety symptom severity range from 0 to 21 with higher scores indicating more severe anxiety.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
0 weeks
|
6.65 score on a scale
Standard Deviation 4.22
|
|
Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
12 weeks
|
5.55 score on a scale
Standard Deviation 4.08
|
|
Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
16 weeks
|
5.47 score on a scale
Standard Deviation 4.33
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Depressive symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS). Seven items measure severity of depressive symptoms. Scores for depressive symptom severity range from 0 to 21 with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
0 weeks
|
6.61 score on a scale
Standard Deviation 4.26
|
|
Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
12 weeks
|
5.74 score on a scale
Standard Deviation 4.67
|
|
Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
16 weeks
|
5.20 score on a scale
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Hyperarousal symptoms will be measured using the 16-item Pre-Sleep Arousal Scale (PSAS). Eight items measure severity of somatic hyperarousal symptoms. Scores for somatic hyperarousal symptom severity range from 8 to 40 with higher scores indicating worse somatic hyperarousal severity.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Severity of Somatic Hyperarousal Symptoms
0 weeks
|
14.42 score on a scale
Standard Deviation 5.89
|
|
Severity of Somatic Hyperarousal Symptoms
12 weeks
|
11.65 score on a scale
Standard Deviation 3.08
|
|
Severity of Somatic Hyperarousal Symptoms
16 weeks
|
11.90 score on a scale
Standard Deviation 3.99
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Hyperarousal symptoms will be measured using the 16-item Pre-Sleep Arousal Scale (PSAS). Eight items measure severity of cognitive hyperarousal symptoms. Scores for cognitive hyperarousal symptom severity range from 8 to 40 with higher scores indicating worse cognitive hyperarousal severity.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Severity of Cognitive Hyperarousal Symptoms
0 weeks
|
18.61 score on a scale
Standard Deviation 7.16
|
|
Severity of Cognitive Hyperarousal Symptoms
12 weeks
|
15.13 score on a scale
Standard Deviation 5.48
|
|
Severity of Cognitive Hyperarousal Symptoms
16 weeks
|
15.40 score on a scale
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Observing (range: 12-60) is measured by 12 items. Higher scores indicate higher levels of observing skills.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing
0 weeks
|
36.29 score on a scale
Standard Deviation 9.00
|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing
12 weeks
|
39.23 score on a scale
Standard Deviation 8.46
|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing
16 weeks
|
39.37 score on a scale
Standard Deviation 9.32
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Describing (range: 8-40) is measured by eight items. Higher scores indicate higher levels of describing skills.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing
16 weeks
|
29.70 score on a scale
Standard Deviation 5.68
|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing
0 weeks
|
28.74 score on a scale
Standard Deviation 5.85
|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing
12 weeks
|
28.74 score on a scale
Standard Deviation 5.68
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Acting with awareness (range: 10-50) is measured by ten items. Higher scores indicate higher levels of acting with awareness skills.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness
0 weeks
|
32.32 score on a scale
Standard Deviation 5.78
|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness
12 weeks
|
32.77 score on a scale
Standard Deviation 5.52
|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness
16 weeks
|
31.57 score on a scale
Standard Deviation 5.46
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Accepting is measured by nine items (range: 9-45). Higher scores indicate higher levels of accepting skills.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement
0 weeks
|
32.00 score on a scale
Standard Deviation 8.43
|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement
12 weeks
|
34.29 score on a scale
Standard Deviation 5.72
|
|
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement
16 weeks
|
33.77 score on a scale
Standard Deviation 8.16
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
SEMCD scores range from 0 to 10 with higher scores indicating greater self-efficacy for symptom management.
Outcome measures
| Measure |
Phase 2: Single-Arm Pilot (Months 12-23)
n=37 Participants
Patients with hematologic cancer endorsing insomnia symptoms, and symptoms of fatigue, pain, and/or distress participated in a single-arm pilot trial.
Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)
The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills: Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
|
|---|---|
|
Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)
16 weeks
|
6.90 score on a scale
Standard Deviation 1.91
|
|
Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)
0 weeks
|
6.05 score on a scale
Standard Deviation 2.17
|
|
Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)
12 weeks
|
6.88 score on a scale
Standard Deviation 1.82
|
Adverse Events
Phase 1 Part 1: Focus Group Patients and Providers (Months 0-6)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Part 2: Patient User Testing (Months 6-12) and Phase 2: Single-Arm Pilot (Months 12-23)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 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