Breast Cancer, Insomnia
Conditions
Brief summary
PRIMARY OBJECTIVE(S): To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy. SECONDARY OBJECTIVE(S): * To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy. * To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators
Interventions
BEHAVIORALHealthy Eating Education Learning (HEAL)
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * Diagnosis of Breast Cancer (Stage I-IIIA) * Scheduled for planned cancer treatment (eg, chemotherapy or biologic agents), or treatment is continuing * Has ≥ 6 weeks of cancer treatment (eg, chemotherapy or biologic agents) remaining * ≥ 21 years of age. * Able to understand written and spoken English. * Sleep disturbance of 8 or greater on the ISI, and insomnia that began or got worse with diagnosis of cancer or treatment with chemotherapy (to exclude pre-existing, chronic insomnia). * Karnofsky score ≥ 70
Exclusion criteria
* Have an unstable self-reported medical or psychiatric illness (Axis I - current or within the last 5 years). * Be currently pregnant or nursing * History of substance abuse or meet criteria for current alcohol abuse or dependence * History (self-reported) of sleep apnea or restless leg syndrome (RLS) * Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol * Unable or unwilling to discontinue anxiolytics within 4 hours of education sessions * Irregular heartbeat or arrhythmia (self-reported or in the medical record)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 12 months | The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: * 0 to 7 = No clinically significant insomnia * 8 to14 = Sub-threshold insomnia (mild) * 15 to 21 = Clinical insomnia (moderate severity) * 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Assessment of Depression (CAD) | 12 months | Anxiety and depression will be assessed by administration of the Clinical Assessment of Depression (CAD). The CAD questionnaire is a 50-item survey, with each statement having 4 possible responses (Strongly Disagree to Strongly Agree), scored from 1 to 4, The raw scores are then converted to T-scores. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. The CAD survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CAD scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. |
| Comprehensive Trail Making Test (CTMT) | At baseline, post intervention, 6 months and 12 months | Neuropsychological assessments will be conducted using the Comprehensive Trail Making Test (CTMT), an assessment of simple attention and executive function, consisting of 5 dot-to-dot exercises that increase with complexity and difficulty. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. Overall, higher values indicate better executive functioning, attention, and processing speed. The CTMT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CTMT scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. |
| Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | At baseline, post intervention, 6 months and 12 months | Neuropsychological assessments will be conducted using the Delayed Recall sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score. A higher T scores indicating better memory (recall).A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Delayed Recall was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. |
| Brief Fatigue Inventory (BFI) | 12 months | The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers (No fatigue to As bad as you can imagine), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall BFI scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. |
| Controlled Oral Word Association Test (COWAT) | At baseline, post intervention, 6 months and 12 months | Neuropsychological assessments will be conducted using the Controlled Oral Word Association Test (COWAT), a verbal fluency task that assesses complex cognition. The test value is the the count of words that meet pre-defined criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Adjustments are made to the raw score based on participant age and education level, resulting in a scaled score. Higher scores reflect a better outcome, meaning better cognition and verbal fluency. The COWAT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the COWAT score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. |
| Mobile Cognitive Assessment Battery (MCAB) | At baseline, post intervention, 6 months and 12 months | Cognitive difficulties will be assessed by administration of the Mobile Cognitive Assessment Battery (MCAB), comprised of 3 neuropsychological tests and a self-reported assessment. MCAB measures cognitive flexibility, accuracy, processing speed, working memory and multitasking. The MCAB survey was to be conducted at baseline, post intervention, 6 months, and 12 months. The outcome was to be reported as the mean of the overall MCAB scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. |
| Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | At baseline, post intervention, 6 months and 12 months | Neuropsychological assessments will be conducted using the Verbal Learning and Memory sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score.The higher T scores indicating better memory (recall). A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Verbal Learning and Memory was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Eating Education Learning (HEAL) Control group. Healthy Eating Education Learning (HEAL) | 66 |
| Brief Behavioral Therapy for Insomnia (BBT-I) Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I) | 73 |
| Total | 139 |
Baseline characteristics
| Characteristic | Healthy Eating Education Learning (HEAL) | Brief Behavioral Therapy for Insomnia (BBT-I) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 10 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 63 Participants | 126 Participants |
| Age, Continuous | 49.7 years STANDARD_DEVIATION 10 | 51.1 years STANDARD_DEVIATION 11.5 | 50.4 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 62 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 15 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 40 Participants | 49 Participants | 89 Participants |
| Region of Enrollment United States | 66 participants | 73 participants | 139 participants |
| Sex: Female, Male Female | 66 Participants | 73 Participants | 139 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 3 / 73 |
| other Total, other adverse events | 17 / 66 | 19 / 73 |
| serious Total, serious adverse events | 3 / 66 | 7 / 73 |
Outcome results
Primary
Insomnia Severity Index (ISI)
The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: * 0 to 7 = No clinically significant insomnia * 8 to14 = Sub-threshold insomnia (mild) * 15 to 21 = Clinical insomnia (moderate severity) * 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months.
Time frame: 12 months
Population: T2 (Post intervention): 5 participants were lost to follow up \& didn't complete any measures.~T3 (6 months follow-up): 16 participants did not complete any measures \& were lost to follow up (including 2 deceased).~T4 (12 months follow-up): 14 participants did not complete any measures \& were lost to follow up (including 3 deceased).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Eating Education Learning (HEAL) | Insomnia Severity Index (ISI) | T1 (Baseline) | 13.73 score on a scale | Standard Deviation 5.11 |
| Healthy Eating Education Learning (HEAL) | Insomnia Severity Index (ISI) | T2 (Post intervention) | 11.28 score on a scale | Standard Deviation 5.43 |
| Healthy Eating Education Learning (HEAL) | Insomnia Severity Index (ISI) | T3 (6 months follow-up) | 9.53 score on a scale | Standard Deviation 5.33 |
| Healthy Eating Education Learning (HEAL) | Insomnia Severity Index (ISI) | T4 (12 months follow-up) | 9.51 score on a scale | Standard Deviation 5.35 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Insomnia Severity Index (ISI) | T4 (12 months follow-up) | 8.98 score on a scale | Standard Deviation 4.93 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Insomnia Severity Index (ISI) | T1 (Baseline) | 14.93 score on a scale | Standard Deviation 4.84 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Insomnia Severity Index (ISI) | T3 (6 months follow-up) | 8.87 score on a scale | Standard Deviation 5.87 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Insomnia Severity Index (ISI) | T2 (Post intervention) | 10.16 score on a scale | Standard Deviation 4.31 |
Secondary
Brief Fatigue Inventory (BFI)
The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers (No fatigue to As bad as you can imagine), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall BFI scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time frame: 12 months
Population: T2: 5 participants were lost to follow up \& did not complete any measures. T3: 16 participants did not complete any measures \& were lost to follow up (including 2 deceased).~T4: 14 participants did not complete any measures \& were lost to follow up (including 3 deceased).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Eating Education Learning (HEAL) | Brief Fatigue Inventory (BFI) | T1 (Baseline) | 4.44 score on a scale | Standard Deviation 2.28 |
| Healthy Eating Education Learning (HEAL) | Brief Fatigue Inventory (BFI) | T2 (Post intervention) | 4.32 score on a scale | Standard Deviation 2.2 |
| Healthy Eating Education Learning (HEAL) | Brief Fatigue Inventory (BFI) | T3 (6 months follow-up) | 3.27 score on a scale | Standard Deviation 2.07 |
| Healthy Eating Education Learning (HEAL) | Brief Fatigue Inventory (BFI) | T4 (12 months follow-up) | 3.28 score on a scale | Standard Deviation 2.18 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Brief Fatigue Inventory (BFI) | T4 (12 months follow-up) | 2.80 score on a scale | Standard Deviation 2.09 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Brief Fatigue Inventory (BFI) | T1 (Baseline) | 4.02 score on a scale | Standard Deviation 2.27 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Brief Fatigue Inventory (BFI) | T3 (6 months follow-up) | 3.00 score on a scale | Standard Deviation 2.03 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Brief Fatigue Inventory (BFI) | T2 (Post intervention) | 3.88 score on a scale | Standard Deviation 2.2 |
Secondary
Clinical Assessment of Depression (CAD)
Anxiety and depression will be assessed by administration of the Clinical Assessment of Depression (CAD). The CAD questionnaire is a 50-item survey, with each statement having 4 possible responses (Strongly Disagree to Strongly Agree), scored from 1 to 4, The raw scores are then converted to T-scores. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. The CAD survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CAD scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time frame: 12 months
Population: T2(Post intervention): 6 participants were lost to follow \& did not complete any measures.~T3(6 months follow-up): 19 participants did not complete follow-up study visit \& were lost to follow up (including 2 deceased).~T4(12 months follow-up): 17 participants did not complete follow-up study visit \& were lost to follow up (including 3 deceased).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Eating Education Learning (HEAL) | Clinical Assessment of Depression (CAD) | T1 (Baseline) | 54.38 score on a scale | Standard Deviation 11.86 |
| Healthy Eating Education Learning (HEAL) | Clinical Assessment of Depression (CAD) | T2 (Post intervention) | 53.14 score on a scale | Standard Deviation 11.25 |
| Healthy Eating Education Learning (HEAL) | Clinical Assessment of Depression (CAD) | T3 (6 months follow-up) | 51.15 score on a scale | Standard Deviation 13.13 |
| Healthy Eating Education Learning (HEAL) | Clinical Assessment of Depression (CAD) | T4 (12 months follow-up) | 49.74 score on a scale | Standard Deviation 12.58 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Clinical Assessment of Depression (CAD) | T4 (12 months follow-up) | 50.60 score on a scale | Standard Deviation 10.66 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Clinical Assessment of Depression (CAD) | T1 (Baseline) | 55.44 score on a scale | Standard Deviation 10.8 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Clinical Assessment of Depression (CAD) | T3 (6 months follow-up) | 51.40 score on a scale | Standard Deviation 10.58 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Clinical Assessment of Depression (CAD) | T2 (Post intervention) | 54.32 score on a scale | Standard Deviation 11.59 |
Secondary
Comprehensive Trail Making Test (CTMT)
Neuropsychological assessments will be conducted using the Comprehensive Trail Making Test (CTMT), an assessment of simple attention and executive function, consisting of 5 dot-to-dot exercises that increase with complexity and difficulty. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. Overall, higher values indicate better executive functioning, attention, and processing speed. The CTMT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CTMT scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time frame: At baseline, post intervention, 6 months and 12 months
Population: T1(Baseline): 1 participant did not complete baseline assessment. T2(Post intervention): Total 7 participants were not analyzed; 6 participants were lost to follow up and 1 participant did not complete this measure T3(6 months follow-up): 19 participants did not complete follow-up (including 2 deceased).~T4(12 months follow-up): 18 participants did not complete follow-up(including 3 deceased).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Eating Education Learning (HEAL) | Comprehensive Trail Making Test (CTMT) | T1 (Baseline) | 44.22 score on a scale | Standard Deviation 7.76 |
| Healthy Eating Education Learning (HEAL) | Comprehensive Trail Making Test (CTMT) | T2 (Post intervention) | 48.68 score on a scale | Standard Deviation 8.79 |
| Healthy Eating Education Learning (HEAL) | Comprehensive Trail Making Test (CTMT) | T3 (6 months follow-up) | 48.68 score on a scale | Standard Deviation 8.29 |
| Healthy Eating Education Learning (HEAL) | Comprehensive Trail Making Test (CTMT) | T4 (12 months follow-up) | 49.26 score on a scale | Standard Deviation 7.86 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Comprehensive Trail Making Test (CTMT) | T4 (12 months follow-up) | 47.92 score on a scale | Standard Deviation 7.56 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Comprehensive Trail Making Test (CTMT) | T1 (Baseline) | 41.44 score on a scale | Standard Deviation 7.98 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Comprehensive Trail Making Test (CTMT) | T3 (6 months follow-up) | 46.53 score on a scale | Standard Deviation 8.33 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Comprehensive Trail Making Test (CTMT) | T2 (Post intervention) | 45.04 score on a scale | Standard Deviation 8.68 |
Secondary
Controlled Oral Word Association Test (COWAT)
Neuropsychological assessments will be conducted using the Controlled Oral Word Association Test (COWAT), a verbal fluency task that assesses complex cognition. The test value is the the count of words that meet pre-defined criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Adjustments are made to the raw score based on participant age and education level, resulting in a scaled score. Higher scores reflect a better outcome, meaning better cognition and verbal fluency. The COWAT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the COWAT score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time frame: At baseline, post intervention, 6 months and 12 months
Population: T2: 6 participants were lost to follow \& did not complete any measures. T3: 18 participants did not complete the 6-month follow-up study visit \& were lost to follow up (including 2 deceased).~T4: 17 participants did not complete the 12-month follow-up study visit \& were lost to follow up (including 3 deceased).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Eating Education Learning (HEAL) | Controlled Oral Word Association Test (COWAT) | T1 (Baseline) | 41.95 score on a scale | Standard Deviation 9.87 |
| Healthy Eating Education Learning (HEAL) | Controlled Oral Word Association Test (COWAT) | T2 (Post intervention) | 42.19 score on a scale | Standard Deviation 11.36 |
| Healthy Eating Education Learning (HEAL) | Controlled Oral Word Association Test (COWAT) | T3 (6 months follow-up) | 45.72 score on a scale | Standard Deviation 11.11 |
| Healthy Eating Education Learning (HEAL) | Controlled Oral Word Association Test (COWAT) | T4 (12 months follow-up) | 44.61 score on a scale | Standard Deviation 10.22 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Controlled Oral Word Association Test (COWAT) | T4 (12 months follow-up) | 42.73 score on a scale | Standard Deviation 11.77 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Controlled Oral Word Association Test (COWAT) | T1 (Baseline) | 39.51 score on a scale | Standard Deviation 11.97 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Controlled Oral Word Association Test (COWAT) | T3 (6 months follow-up) | 43.53 score on a scale | Standard Deviation 12.06 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Controlled Oral Word Association Test (COWAT) | T2 (Post intervention) | 40.43 score on a scale | Standard Deviation 12.36 |
Secondary
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall
Neuropsychological assessments will be conducted using the Delayed Recall sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score. A higher T scores indicating better memory (recall).A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Delayed Recall was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time frame: At baseline, post intervention, 6 months and 12 months
Population: T2 (Post intervention): 6 participants were lost to follow up \& did not complete any measures.~T3(6 months follow-up): 18 participants did not complete follow-up study visit (including 2 deceased).~T4(12 months follow-up): 17 participants did not complete follow-up study visit (including 3 deceased).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Eating Education Learning (HEAL) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | T1 (Baseline) | 49.05 score on a scale | Standard Deviation 10.83 |
| Healthy Eating Education Learning (HEAL) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | T2 (Post intervention) | 49.06 score on a scale | Standard Deviation 10.95 |
| Healthy Eating Education Learning (HEAL) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | T3 (6 months follow-up) | 50.70 score on a scale | Standard Deviation 9.78 |
| Healthy Eating Education Learning (HEAL) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | T4 (12 months follow-up) | 52.95 score on a scale | Standard Deviation 8.3 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | T4 (12 months follow-up) | 52.68 score on a scale | Standard Deviation 8.67 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | T1 (Baseline) | 49.42 score on a scale | Standard Deviation 9.58 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | T3 (6 months follow-up) | 51.68 score on a scale | Standard Deviation 9.63 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall | T2 (Post intervention) | 46.96 score on a scale | Standard Deviation 11.05 |
Secondary
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory
Neuropsychological assessments will be conducted using the Verbal Learning and Memory sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score.The higher T scores indicating better memory (recall). A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Verbal Learning and Memory was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time frame: At baseline, post intervention, 6 months and 12 months
Population: T2(Post intervention): 6 participants were lost to follow up \& did not complete any measures.~T3 (6 months follow-up): 18 participants did not complete follow-up visit (including 2 deceased).~T4 (12 months follow-up): 17 participants did not complete follow-up visit (including 3 deceased).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Eating Education Learning (HEAL) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | T1 (Baseline) | 48.94 score on a scale | Standard Deviation 11.45 |
| Healthy Eating Education Learning (HEAL) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | T2 (Post intervention) | 49.44 score on a scale | Standard Deviation 12.27 |
| Healthy Eating Education Learning (HEAL) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | T3 (6 months follow-up) | 53.21 score on a scale | Standard Deviation 10.78 |
| Healthy Eating Education Learning (HEAL) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | T4 (12 months follow-up) | 56.05 score on a scale | Standard Deviation 9.6 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | T4 (12 months follow-up) | 56.93 score on a scale | Standard Deviation 9.99 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | T1 (Baseline) | 50.23 score on a scale | Standard Deviation 11.3 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | T3 (6 months follow-up) | 53.85 score on a scale | Standard Deviation 9.66 |
| Brief Behavioral Therapy for Insomnia (BBT-I) | Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory | T2 (Post intervention) | 50.42 score on a scale | Standard Deviation 11.32 |
Secondary
Mobile Cognitive Assessment Battery (MCAB)
Cognitive difficulties will be assessed by administration of the Mobile Cognitive Assessment Battery (MCAB), comprised of 3 neuropsychological tests and a self-reported assessment. MCAB measures cognitive flexibility, accuracy, processing speed, working memory and multitasking. The MCAB survey was to be conducted at baseline, post intervention, 6 months, and 12 months. The outcome was to be reported as the mean of the overall MCAB scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time frame: At baseline, post intervention, 6 months and 12 months
Population: No analysis. The MCAB analysis was determined to not be a validated measure, and the analysis was not conducted as the scores are not standardized and results do not have meaning at this time.