Cancer, Insomnia
Conditions
Keywords
surgery, chemotherapy, radiation, Acupuncture, 16-947
Brief summary
The aim of this study is to determine which of two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in cancer survivors. The investigator also wants to study the factors that might impact why someone might prefer or do better in one treatment over the other. Group 1 will get Acupuncture - Acupuncture is an ancient Chinese Technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing. Group 2 will get Cognitive Behavioral Therapy for Insomnia (CBT-I) - CBT-I is a treatment to address behaviors and thoughts that are known to effect problems with sleep.
Interventions
OTHERAcupuncture
OTHERCognitive Behavior Therapy
Sponsors
University of Pennsylvania
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English-speaking, age ≥ 18 years old * A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria are not be restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites. * Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded). * A score \>7 on our primary outcome (the Insomnia Severity Index) * A diagnosis of insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5), per the diagnostic interview. According to this nosology, insomnia is defined as dissatisfaction with sleep quality or quantity characterized by difficulty initiating sleep, maintaining sleep, or early morning awakenings that cause significant distress or impairment in daytime functioning and occur at least three nights per week for at least three months despite adequate opportunity for sleep. * Patients using psychotropic medication (e.g. antidepressants) will remain eligible for study participation provided that the dose was not recently altered (stable over the previous 6-weeks). * Patients using hypnotics or sedatives will be eligible for study participation. Considering the high use of benzodiazepines within the oncology population, past research has included participants who met diagnostic criteria for insomnia, despite the use of benzodiazepines, and included monitoring of medication use.
Exclusion criteria
* Another sleep disorder, other than sleep apnea, that is not adequately treated. * Previous experience with CBT or acupuncture to treat insomnia * Currently participating in another acupuncture trial or a trial to treat insomnia * The presence of another Axis I disorder not in remission * Employment in a job requiring shift work that would impair the ability to establish a regular sleep schedule * Patients who are currently taking oral (not including oral sprays/inhalers) or intravenous corticosteroids as part of treatment for cancer or any other condition will be excluded because of the potential of these drugs to induce insomnia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) at Baseline | At Baseline | The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28. |
| Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks | 8 weeks from baseline | A greater negative value represents improvement in symptoms. The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28. |
| Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks | 20 weeks from baseline | A greater negative value represents improvement in symptoms. The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Consensus Sleep Diary (CSD) Baseline Sleep Onset | Baseline | The Consensus Sleep Diary (CSD) will be used to calculate sleep onset at baseline. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8 | 8 weeks from baseline | A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 8. The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20 | 20 weeks from baseline | A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 20. The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline | Baseline | The Consensus Sleep Diary (CSD) will be used to calculate wake after sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8 | 8 weeks from baseline | A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 8. The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks | 20 weeks from baseline | A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 20. The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Baseline Total Sleep Time | Baseline | The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8 | 8 weeks from baseline | A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 8. The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20 | 20 weeks from baseline | A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 20. The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment. |
| The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline | Baseline | Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. A higher number indicates better sleep efficiency. |
| The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8 | 8 weeks from baseline | A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 8. Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency. |
| The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20 | 20 weeks from baseline | A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 20. Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency. |
| Brief Pain Inventory (BPI) at Baseline | Baseline | Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom. |
| Brief Pain Inventory (BPI) Change From Baseline at Week 8 | 8 weeks from baseline | A greater negative value represents improvement in symptoms. Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom. |
| The Brief Pain Inventory (BPI) Change From Baseline at Week 20 | 20 weeks from baseline | A greater negative value represents improvement in symptoms. Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom. |
| Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline | Baseline | The Multidimensional Fatigue Inventory-Short Form (MFSI-SF) is a 30 item self-report measure. Higher scores indicate more fatigue. A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue. |
| Pittsburgh Sleep Quality Index (PSQI) at Baseline | Baseline | The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21. |
| Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20 | 20 weeks from baseline | A greater negative value represents improvement in symptoms. A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue. |
| Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline | Baseline | This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinicao; and 11-21 clinically significant depression/anxiety. |
| Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8 | 8 weeks from baseline | A greater negative value represents improvement in symptoms. This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety. |
| Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20 | 20 weeks from baseline | A greater negative value represents improvement in symptoms. This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety. |
| Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline | Baseline | This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety. |
| Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8 | 8 weeks from baseline | A greater negative value represents improvement in symptoms. This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety. |
| Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20 | 20 weeks | A greater negative value represents improvement in symptoms. This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety. |
| Global Physical Health Scale (PROMIS® Global 10) at Baseline | Baseline | The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline. |
| Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8 | 8 weeks from baseline | A greater positive value represents improvement in symptoms. The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline. |
| Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20 | 20 weeks from baseline | A greater positive value represents improvement in symptoms. The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline. |
| Global Mental Health Scale (PROMIS® Global 10) at Baseline | Baseline | The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline. |
| Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8 | 8 weeks from baseline | A greater positive value represents improvement in symptoms. The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline. |
| Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20 | 20 weeks from baseline | A greater positive value represents improvement in symptoms. The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline. |
| Treatment Expectancy Scale: Expectancy for CBT-I Treatment | Baseline | A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy. |
| Treatment Expectancy Scale: Expectancy for Acupuncture Treatment | Baseline | A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy. |
| Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8 | 8 weeks from baseline | A greater negative value represents improvement in symptoms. A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue. |
| Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks | 8 weeks from baseline | A greater negative value represents improvement in symptoms. Please note this is the change in score from baseline at 8 weeks. The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21. |
| Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks | 20 weeks from baseline | A greater negative value represents improvement in symptoms. Please note that this is the change in score from baseline to 20 weeks. The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture Group In the acupuncture group, patients will receive ten treatments of acupuncture over eight weeks.
Acupuncture | 80 |
| CBT-I Group In the CBT-I group, patients will receive seven sessions of CBT-I over eight weeks.
Cognitive Behavior Therapy | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | CBT-I Group | Total | Acupuncture Group |
|---|---|---|---|
| Age, Continuous | 60.7 years | 61.5 years | 62.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 152 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 44 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 113 Participants | 61 Participants |
| Region of Enrollment United States | 80 Participants | 160 Participants | 80 Participants |
| Sex: Female, Male Female | 48 Participants | 91 Participants | 43 Participants |
| Sex: Female, Male Male | 32 Participants | 69 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 10 / 80 | 5 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
Insomnia Severity Index (ISI) at Baseline
The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Time frame: At Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Insomnia Severity Index (ISI) at Baseline | 17.6 score on a scale | Standard Deviation 4.1 |
| CBT-I Group | Insomnia Severity Index (ISI) at Baseline | 18.5 score on a scale | Standard Deviation 4.4 |
Primary
Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks
A greater negative value represents improvement in symptoms. The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks | -8.59 units on a scale |
| CBT-I Group | Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks | -11.12 units on a scale |
Primary
Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks
A greater negative value represents improvement in symptoms. The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks | -8.31 units on a scale |
| CBT-I Group | Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks | -10.91 units on a scale |
Secondary
Brief Pain Inventory (BPI) at Baseline
Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Brief Pain Inventory (BPI) at Baseline | 2.4 units on a scale | Standard Deviation 2.4 |
| CBT-I Group | Brief Pain Inventory (BPI) at Baseline | 2.1 units on a scale | Standard Deviation 2 |
Secondary
Brief Pain Inventory (BPI) Change From Baseline at Week 8
A greater negative value represents improvement in symptoms. Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Brief Pain Inventory (BPI) Change From Baseline at Week 8 | -0.49 units on a scale |
| CBT-I Group | Brief Pain Inventory (BPI) Change From Baseline at Week 8 | 0.00 units on a scale |
Secondary
Global Mental Health Scale (PROMIS® Global 10) at Baseline
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Global Mental Health Scale (PROMIS® Global 10) at Baseline | 45.0 units on a scale | Standard Deviation 8 |
| CBT-I Group | Global Mental Health Scale (PROMIS® Global 10) at Baseline | 44.1 units on a scale | Standard Deviation 8.2 |
Secondary
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
A greater positive value represents improvement in symptoms. The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20 | 4.08 units on a scale |
| CBT-I Group | Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20 | 3.29 units on a scale |
Secondary
Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
A greater positive value represents improvement in symptoms. The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8 | 3.34 units on a scale |
| CBT-I Group | Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8 | 3.39 units on a scale |
Secondary
Global Physical Health Scale (PROMIS® Global 10) at Baseline
The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Global Physical Health Scale (PROMIS® Global 10) at Baseline | 45.2 units on a scale | Standard Deviation 8.4 |
| CBT-I Group | Global Physical Health Scale (PROMIS® Global 10) at Baseline | 43.4 units on a scale | Standard Deviation 8.7 |
Secondary
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20
A greater positive value represents improvement in symptoms. The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20 | 3.29 units on a scale |
| CBT-I Group | Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20 | 4.49 units on a scale |
Secondary
Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8
A greater positive value represents improvement in symptoms. The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8 | 2.19 units on a scale |
| CBT-I Group | Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8 | 3.73 units on a scale |
Secondary
Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline
This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinicao; and 11-21 clinically significant depression/anxiety.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline | 7.8 units on a scale | Standard Deviation 4 |
| CBT-I Group | Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline | 7.8 units on a scale | Standard Deviation 4.3 |
Secondary
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20
A greater negative value represents improvement in symptoms. This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20 | -1.94 units on a scale |
| CBT-I Group | Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20 | -1.83 units on a scale |
Secondary
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8
A greater negative value represents improvement in symptoms. This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8 | -2.21 units on a scale |
| CBT-I Group | Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8 | -1.93 units on a scale |
Secondary
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20
A greater negative value represents improvement in symptoms. This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20 | -0.91 units on a scale |
| CBT-I Group | Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20 | -1.22 units on a scale |
Secondary
Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8
A greater negative value represents improvement in symptoms. This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8 | -1.06 units on a scale |
| CBT-I Group | Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8 | -1.45 units on a scale |
Secondary
Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline
This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline | 4.6 units on a scale | Standard Deviation 3.1 |
| CBT-I Group | Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline | 5.1 units on a scale | Standard Deviation 3.4 |
Secondary
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline
The Multidimensional Fatigue Inventory-Short Form (MFSI-SF) is a 30 item self-report measure. Higher scores indicate more fatigue. A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline | 19.8 units on a scale | Standard Deviation 21.3 |
| CBT-I Group | Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline | 21.9 units on a scale | Standard Deviation 22.3 |
Secondary
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20
A greater negative value represents improvement in symptoms. A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20 | -12.20 score on MFSI-F |
| CBT-I Group | Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20 | -11.19 score on MFSI-F |
Secondary
Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8
A greater negative value represents improvement in symptoms. A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8 | -10.82 units on a scale |
| CBT-I Group | Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8 | -12.48 units on a scale |
Secondary
Pittsburgh Sleep Quality Index (PSQI) at Baseline
The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Pittsburgh Sleep Quality Index (PSQI) at Baseline | 11.8 units on a scale | Standard Deviation 3.2 |
| CBT-I Group | Pittsburgh Sleep Quality Index (PSQI) at Baseline | 12.1 units on a scale | Standard Deviation 3.7 |
Secondary
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks
A greater negative value represents improvement in symptoms. Please note this is the change in score from baseline at 8 weeks. The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks | -4.39 units on a scale |
| CBT-I Group | Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks | -5.90 units on a scale |
Secondary
Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks
A greater negative value represents improvement in symptoms. Please note that this is the change in score from baseline to 20 weeks. The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks | -4.62 units on a scale |
| CBT-I Group | Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks | -5.84 units on a scale |
Secondary
The Brief Pain Inventory (BPI) Change From Baseline at Week 20
A greater negative value represents improvement in symptoms. Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Brief Pain Inventory (BPI) Change From Baseline at Week 20 | -0.46 units on a scale |
| CBT-I Group | The Brief Pain Inventory (BPI) Change From Baseline at Week 20 | -0.35 units on a scale |
Secondary
The Consensus Sleep Diary (CSD) Baseline Sleep Onset
The Consensus Sleep Diary (CSD) will be used to calculate sleep onset at baseline. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Baseline Sleep Onset | 32.1 minutes | Standard Deviation 29.3 |
| CBT-I Group | The Consensus Sleep Diary (CSD) Baseline Sleep Onset | 47.1 minutes | Standard Deviation 62.1 |
Secondary
The Consensus Sleep Diary (CSD) Baseline Total Sleep Time
The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Baseline Total Sleep Time | 346.1 minutes | Standard Deviation 82.1 |
| CBT-I Group | The Consensus Sleep Diary (CSD) Baseline Total Sleep Time | 340.8 minutes | Standard Deviation 99.2 |
Secondary
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline
The Consensus Sleep Diary (CSD) will be used to calculate wake after sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline | 58.0 minutes | Standard Error 38.8 |
| CBT-I Group | The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline | 53.6 minutes | Standard Error 42.1 |
Secondary
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks
A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 20. The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks | -22.01 minutes |
| CBT-I Group | The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks | -29.51 minutes |
Secondary
The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8
A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 8. The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8 | -26.89 minutes |
| CBT-I Group | The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8 | -35.83 minutes |
Secondary
The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline
Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. A higher number indicates better sleep efficiency.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline | 73.2 percentage of efficiency | Standard Deviation 13.5 |
| CBT-I Group | The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline | 72.1 percentage of efficiency | Standard Deviation 18.3 |
Secondary
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20
A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 20. Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20 | 0.10 percentage change |
| CBT-I Group | The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20 | 0.13 percentage change |
Secondary
The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8
A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 8. Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8 | 0.11 percentage change |
| CBT-I Group | The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8 | 0.16 percentage change |
Secondary
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20
A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 20. The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20 | -10.91 minutes |
| CBT-I Group | The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20 | -24.37 minutes |
Secondary
The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8
A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 8. The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8 | -10.80 minutes |
| CBT-I Group | The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8 | -27.13 minutes |
Secondary
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20
A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 20. The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: 20 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20 | 50.71 minutes |
| CBT-I Group | The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20 | 45.23 minutes |
Secondary
The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8
A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 8. The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.
Time frame: 8 weeks from baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture Group | The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8 | 61.81 minutes |
| CBT-I Group | The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8 | 35.01 minutes |
Secondary
Treatment Expectancy Scale: Expectancy for Acupuncture Treatment
A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Treatment Expectancy Scale: Expectancy for Acupuncture Treatment | 13.3 units on a scale | Standard Deviation 4 |
| CBT-I Group | Treatment Expectancy Scale: Expectancy for Acupuncture Treatment | 13.2 units on a scale | Standard Deviation 3.2 |
Secondary
Treatment Expectancy Scale: Expectancy for CBT-I Treatment
A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture Group | Treatment Expectancy Scale: Expectancy for CBT-I Treatment | 12.8 units on a scale | Standard Deviation 3.5 |
| CBT-I Group | Treatment Expectancy Scale: Expectancy for CBT-I Treatment | 13.2 units on a scale | Standard Deviation 2.9 |