Hematologic Malignancy
Conditions
Brief summary
Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy. Poor sleep quality can contribute to and perpetuate problems with daytime fatigue, pain, and distress that are common among patients with hematologic cancer. There is a need for behavioral interventions that address insomnia and daytime fatigue, pain, and distress once hematologic cancer patients have returned home after inpatient chemotherapy. Mindfulness-Based Therapy for Insomnia (MBTI) is a new approach to treating insomnia. This group-based intervention combines sleep restriction and stimulus control with mindfulness principles and exercises to reduce worry and promote positive responses to insomnia. To date, MBTI has not been applied to patients with hematologic cancer. If MBTI is to meet the needs of hematologic cancer patients, it must be adapted in several ways. First, because hematologic cancer patients are immunosuppressed, MBTI needs to be adapted for one-to-one delivery. Second, because hematologic cancer patients experience significant daytime fatigue, pain, and distress, MBTI needs to be adapted to include systematic training in coping skills for these symptoms. The investigators propose to develop and pilot test an adapted MBTI (MBTI+) protocol for hematologic cancer patients reporting insomnia, fatigue, pain, and/or distress after inpatient chemotherapy. The study will be conducted in two phases. In Phase I, the study team will use focus groups with hematologic cancer patients and hematology-oncology providers to guide development along with user testing with hematologic cancer patients reporting insomnia and daytime symptoms of fatigue, pain, and/or distress. Phase II will involve a small single-arm pilot to examine the feasibility, acceptability, and examine pre- to post-intervention primary (insomnia) and secondary (fatigue, pain, distress, mindfulness, self-efficacy) outcomes of the MBTI+ protocol. MBTI+ will consist of six, 60- to 75-minute therapy sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.
Interventions
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* an initial or recurrent diagnosis of hematologic malignancy * within 8 weeks of discharge home after inpatient chemotherapy or CAR-T therapy * total score of 8 or greater on the Insomnia Severity Index (ISI) * score of 5 or greater on the MD Anderson Symptom Inventory Scale for worst fatigue, pain, or distress, and report that these symptoms interfered with at least two activities of living (i.e., general activity, mood, work) in the last week at 3 or greater on a 0=Did not interfere to 10=Interfered completely scale * ability to speak and read English, and hearing and vision that allows for completion of sessions and assessments
Exclusion criteria
* reported or suspected cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of \<25 * presence of a serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, treating oncologist or other medical provider that would contraindicate safe participation * expected survival of 6 months or less
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot | 12 weeks (post-intervention) | Treatment feasibility will be indicated by meeting target study accrual (i.e., 30 participants consented and enrolled for single-arm pilot). |
| Feasibility as Measured by Study Attrition at Post-intervention Follow-up | 12 weeks (post-intervention) | Treatment feasibility will be indicated by less than or equal to 20% study attrition at post-intervention follow-up. |
| Feasibility as Measured by Adherence to the Intervention | 12 weeks (post-intervention) | Adherence will be indicated by at least 80% of the participants completing all 6 intervention sessions. |
| Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) | 12 weeks (post-intervention) | 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. |
| Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI) | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS) | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Severity of Somatic Hyperarousal Symptoms | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Severity of Cognitive Hyperarousal Symptoms | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI) | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD) | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | SEMCD scores range from 0 to 10 with higher scores indicating greater self-efficacy for symptom management. |
| Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI) | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF) | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
| Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS) | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 6 |
| 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. | 5 |
| 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. | 32 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Phase 1 Part 1: Focus Group Patients (Months 0-6) | Total | Phase 2: Single-Arm Pilot (Months 12-23) | Phase 1 Part 2: Patient User Testing (Months 6-12) | Phase 1 Part 1: Focus Group Providers (Months 0-6) |
|---|---|---|---|---|---|
| Age, Continuous | 56.86 years STANDARD_DEVIATION 15.85 | 49.39 years STANDARD_DEVIATION 17.35 | 50.75 years STANDARD_DEVIATION 19.64 | 36.00 years STANDARD_DEVIATION 12.27 | 36.00 years STANDARD_DEVIATION 10.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 53 Participants | 28 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 10 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 44 Participants | 26 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 14 Participants | 57 Participants | 32 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Female | 6 Participants | 33 Participants | 17 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 24 Participants | 15 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 1 / 37 |
| other Total, other adverse events | 0 / 20 | 0 / 37 |
| serious Total, serious adverse events | 0 / 20 | 0 / 37 |
Outcome results
Primary
Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Acceptability as Measured by the Client Satisfaction Questionnaire (CSQ) | 29 Participants |
Primary
Feasibility as Measured by Adherence to the Intervention
Adherence will be indicated by at least 80% of the participants completing all 6 intervention sessions.
Time frame: 12 weeks (post-intervention)
Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Feasibility as Measured by Adherence to the Intervention | 83.80 percentage of participants |
Primary
Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot
Treatment feasibility will be indicated by meeting target study accrual (i.e., 30 participants consented and enrolled for single-arm pilot).
Time frame: 12 weeks (post-intervention)
Population: Individuals who completed phone screening. Only applicable to Phase 2 participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot | 32 Participants |
Primary
Feasibility as Measured by Study Attrition at Post-intervention Follow-up
Treatment feasibility will be indicated by less than or equal to 20% study attrition at post-intervention follow-up.
Time frame: 12 weeks (post-intervention)
Population: Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Feasibility as Measured by Study Attrition at Post-intervention Follow-up | 8.10 percentage of attrition |
Primary
Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI) | 0 weeks | 13.45 score on a scale | Standard Deviation 6.19 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI) | 12 weeks | 6.26 score on a scale | Standard Deviation 4.46 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI) | 16 weeks | 6.07 score on a scale | Standard Deviation 3.99 |
Comparison: 0 to 12 weeks95% CI: [0.73, 1.66]
Comparison: 0 to 16 weeks95% CI: [0.61, 1.51]
Secondary
Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI) | 0 weeks | 4.18 score on a scale | Standard Deviation 2.49 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI) | 12 weeks | 2.70 score on a scale | Standard Deviation 2.55 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI) | 16 weeks | 3.09 score on a scale | Standard Deviation 2.44 |
Comparison: 0 to 12 weeks95% CI: [0.38, 1.18]
Comparison: 0 to 16 weeks95% CI: [0.11, 0.87]
Secondary
Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI) | 0 weeks | 4.48 score on a scale | Standard Deviation 1.97 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI) | 12 weeks | 3.69 score on a scale | Standard Deviation 2.03 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI) | 16 weeks | 4.06 score on a scale | Standard Deviation 2.32 |
Comparison: 0 to 12 weeks95% CI: [-0.02, 0.71]
Comparison: 0 to 16 weeks95% CI: [-0.12, 0.61]
Secondary
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
Comparison: 0 to 12 weeks95% CI: [-0.71, 0.01]
Comparison: 0 to 16 weeks95% CI: [-0.65, 0.08]
Secondary
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
95% CI: [-0.45, 0.26]
Comparison: 0 to 16 weeks95% CI: [-0.27, 0.45]
Secondary
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
Comparison: 0 to 12 weeks95% CI: [-0.35, 0.35]
Comparison: 0 to 16 weeks95% CI: [-0.64, 0.09]
Secondary
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing | 0 weeks | 36.29 score on a scale | Standard Deviation 9 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
Comparison: 0 to 12 weeks95% CI: [-0.76, -0.03]
Comparison: 0 to 16 weeks95% CI: [-0.71, 0.03]
Secondary
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
Comparison: 0 to 12 weeks95% CI: [-0.04, 0.68]
Comparison: 0 to 16 weeks95% CI: [0.22, 1]
Secondary
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
Comparison: 0 to 12 weeks95% CI: [-0.13, 0.58]
Comparison: 0 to 16 weeks95% CI: [-0.05, 0.68]
Secondary
Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)
SEMCD scores range from 0 to 10 with higher scores indicating greater self-efficacy for symptom management.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
Comparison: 0 to 12 weeks95% CI: [-0.7, 0.03]
Comparison: 0 to 16 weeks95% CI: [-0.85, -0.09]
Secondary
Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
Comparison: 0 to 12 weeks95% CI: [0.01, 0.74]
Comparison: 0 to 16 weeks95% CI: [0.09, 0.85]
Secondary
Severity of Cognitive Hyperarousal Symptoms
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Severity of Cognitive Hyperarousal Symptoms | 0 weeks | 18.61 score on a scale | Standard Deviation 7.16 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Severity of Cognitive Hyperarousal Symptoms | 12 weeks | 15.13 score on a scale | Standard Deviation 5.48 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Severity of Cognitive Hyperarousal Symptoms | 16 weeks | 15.40 score on a scale | Standard Deviation 6.73 |
Comparison: 0 to 12 weeks95% CI: [0.47, 1.3]
Comparison: 0 to 16 weeks95% CI: [0.26, 1.05]
Secondary
Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
| Phase 2: Single-Arm Pilot (Months 12-23) | 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 |
Comparison: 0 to 12 weeks95% CI: [-0.07, 0.65]
95% CI: [0.21, 0.99]
Secondary
Severity of Somatic Hyperarousal Symptoms
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2: Single-Arm Pilot (Months 12-23) | Severity of Somatic Hyperarousal Symptoms | 0 weeks | 14.42 score on a scale | Standard Deviation 5.89 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Severity of Somatic Hyperarousal Symptoms | 12 weeks | 11.65 score on a scale | Standard Deviation 3.08 |
| Phase 2: Single-Arm Pilot (Months 12-23) | Severity of Somatic Hyperarousal Symptoms | 16 weeks | 11.90 score on a scale | Standard Deviation 3.99 |
Comparison: 0 to 12 weeks95% CI: [0.16, 0.91]
Comparison: 0 to 16 weeks95% CI: [0.12, 0.89]