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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills | Behavioral | Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks (post-intervention) |
| 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. | 12 weeks (post-intervention) |
| Feasibility as Measured by Adherence to the Intervention | Adherence will be indicated by at least 80% of the participants completing all 6 intervention sessions. | 12 weeks (post-intervention) |
| 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. | 12 weeks (post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara J Somers, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38597262 | Derived | Fisher HM, Hyland KA, Miller SN, Amaden GH, Diachina A, Ulmer CS, Danforth M, LeBlanc TW, Somers TJ, Keefe FJ. Mindful Night-to-Day: A Pilot Feasibility Trial of a Mindfulness-Based Insomnia and Symptom Management Intervention for Patients with Hematologic Cancer. Behav Sleep Med. 2024 Sep-Oct;22(5):674-696. doi: 10.1080/15402002.2024.2339819. Epub 2024 Apr 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Individuals who completed phone screening. Only applicable to Phase 2 participants. | Posted | Count of Participants | Participants | 12 weeks (post-intervention) |
|
Phase 1 Part 1 (Focus Group Patients and Providers): Consent/Enrollment to Completion of One-Time, 60-Minute Telehealth Focus Group, approximately 1-4 weeks. Phase 1 Part 2 (User Testing) and Phase 2 (Single-Arm Pilot): Consent/Enrollment to Completion of 1-Month Post-Treatment Assessment (A3), an average of 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 Part 1: Focus Group Patients and Providers (Months 0-6) | Patients with hematologic cancer and hematology-oncology providers that consented and enrolled to complete a one-time, 60-minute, telehealth focus group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hannah Fisher, PhD | Duke University | 919-416-3471 | hannah.fisher@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2023 | May 8, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2023 | May 8, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Single Group Assignment
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| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| 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. | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Number | percentage of attrition | 12 weeks (post-intervention) |
|
|
|
| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Number | percentage of participants | 12 weeks (post-intervention) |
|
|
|
| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants) who completed the intervention protocol. | Posted | Count of Participants | Participants | 12 weeks (post-intervention) |
|
|
|
| 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. | Participants that consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 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. | Participants consented and enrolled to complete the intervention (i.e., user testing and single-arm pilot participants). | Posted | Mean | Standard Deviation | score on a scale | 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Phase 1 Part 2: Patient User Testing (Months 6-12) and Phase 2: Single-Arm Pilot (Months 12-23) | 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. | 1 | 37 | 0 | 37 | 0 | 37 |
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Not provided
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| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 1.07 |
| 2-Sided |
| 95 |
| 0.61 |
| 1.51 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.25 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.61 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.50 |
| 2-Sided |
| 95 |
| 0.11 |
| 0.87 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.31 |
| 2-Sided |
| 95 |
| -0.05 |
| 0.68 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.61 |
| 2-Sided |
| 95 |
| 0.22 |
| 1.00 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.47 |
| 2-Sided |
| 95 |
| 0.09 |
| 0.85 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.60 |
| 2-Sided |
| 95 |
| 0.21 |
| 0.99 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.51 |
| 2-Sided |
| 95 |
| 0.12 |
| 0.89 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.66 |
| 2-Sided |
| 95 |
| 0.26 |
| 1.05 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| -0.34 |
| 2-Sided |
| 95 |
| -0.71 |
| 0.03 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| -0.28 |
| 2-Sided |
| 95 |
| -0.64 |
| 0.09 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| 0.09 |
| 2-Sided |
| 95 |
| -0.27 |
| 0.45 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| -0.29 |
| 2-Sided |
| 95 |
| -0.65 |
| 0.08 |
| Other |
| Title | Measurements |
|---|---|
|
| Cohen's d effect size |
| -0.47 |
| 2-Sided |
| 95 |
| -0.85 |
| -0.09 |
| Other |