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| ID | Type | Description | Link |
|---|---|---|---|
| NS32374 |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Merck Sharp & Dohme LLC | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to determine if the addition of preventive medication, behavior migraine management or the combination of preventive medication and behavior migraine management improves the outcome of optimal acute therapy for frequent migraines.
During the 5 week Optimal Acute Therapy (OAT) Run in (Month 1) all participants who met initial inclusion criteria received "optimal" acute therapy (OAT). At the end of the OAT Run-in, participants who continued to meet the migraine severity criteria were stratified by sex and randomized via a computerized randomization procedure to the four added treatments: Beta Blocker Placebo (PL), Beta Blocker (Propranolol LA or Nadolol), Behavioral Migraine Management (BMM) + PL, or BMM + Beta Blocker. Each of the 4 treatment protocols required 4 monthly clinic visits and 3 telephone contacts during the 3 month Treatment/Dose Adjustment Phase (Month 2 to Month 4) where Beta Blocker or PL dose was adjusted and BMM was administered. During the 12 month (Month 5 to Month 16) Evaluation Phase clinic visits were scheduled at Month 5, Month 7, Month 10 (the Primary End Point), Month 13 and Month 16. Treatment conditions were blinded only for the preventive medication (Beta Blocker, Placebo) component, and not for the administration of BMM. Electronic headache diary recordings are obtained for the full 16 months of the trial, including the 12 month evaluation phase, and migraine-related impairments in quality of life are assessed at multiple points over the 16 months of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Optimal Acute Therapy plus Beta Blocker Placebo |
|
| 2 | Active Comparator | Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol) |
|
| 3 | Active Comparator | Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker placebo |
|
| 4 | Active Comparator | Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol or nadolol | Drug | Treatment initiated with 1 capsule (60 mg long acting propranolol hydrochloride) and increased to 3 capsules (180 mg) at week 12 as tolerated. If subject does not tolerate at least 2 capsules (120 mg) of propranolol hydrochloride-LA, and in treating neurologist's judgment are unimproved, subject switched to second medication (nadolol). Participants initially receive a single 40 mg capsule of nadolol and increased to 2 capsules (80 mg) as tolerated. At week 12 dose stabilized at highest tolerated level. In evaluation phase, an increase to 4 capsules of long acting propranolol hydrochloride (240 mg) or 3 capsules of nadolol (120 mg) permitted. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Migraine Episodes Per 30 Days at Month 10. | Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary. | Change from Month 1 to Month 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Migraine Days Per 30 Days at Month 10 | Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary. | Change from Month 1 to Month 10 |
| Change in Quality of Life at Month 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth A Holroyd, Ph.D. | Ohio University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio University | Athens | Ohio | 45701 | United States | ||
| OrthoNeuro, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10759923 | Background | Martin BC, Pathak DS, Sharfman MI, Adelman JU, Taylor F, Kwong WJ, Jhingran P. Validity and reliability of the migraine-specific quality of life questionnaire (MSQ Version 2.1). Headache. 2000 Mar;40(3):204-15. doi: 10.1046/j.1526-4610.2000.00030.x. | |
| 20880898 | Derived | Holroyd KA, Cottrell CK, O'Donnell FJ, Cordingley GE, Drew JB, Carlson BW, Himawan L. Effect of preventive (beta blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial. BMJ. 2010 Sep 29;341:c4871. doi: 10.1136/bmj.c4871. |
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5 week Optimal Acute Therapy (OAT) Run in (M1) precedes random assignment (see detailed design description).
Outpatient clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | OAT + Placebo (PL) | Optimal Acute Therapy plus Beta Blocker Placebo |
| FG001 | OAT + Beta Blocker (Beta-B) | Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol) |
| FG002 | OAT + BMM + PL | Optimal Acute Therapy plus Behavioral Migraine Management plus placebo |
| FG003 | OAT + BMM + Beta-B | Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 1: Optimal Acute Therapy Run in |
|
| ||||||||||||||||||
| Month 2- 4: Treatment Period |
| |||||||||||||||||||
| Months 5 - 10: Evaluation Period I |
| |||||||||||||||||||
| Months 11- 16: Evaluation Period II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OAT + Placebo (PL) | Optimal Acute Therapy plus Beta Blocker Placebo |
| BG001 | OAT + Beta Blocker (Beta-B) | Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Number of Migraine Episodes Per 30 Days at Month 10. | Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary. | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Posted | Mean | 95% Confidence Interval | Number of Migraine episodes | Change from Month 1 to Month 10 |
|
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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 | OAT + Placebo (PL) at Month 5 | Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/ Nadolol)Placebo. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or Other side effect at Month 5 following dose adjustment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
No side effect reached the 5% reporting threshold at either the Month 10 or the Month 16 assessment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Holroyd | Ohio University | (740) 593-1085 | holroyd@ohio.edu |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D009248 | Nadolol |
| D001521 | Behavior Therapy |
| D018170 | Sumatriptan |
| C093622 | rizatriptan |
| D008787 | Metoclopramide |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo control | Drug | Placebo |
|
| Behavioral Migraine Management (BMM) | Behavioral | Session 1: Overview of the pathophysiology of migraine; introduce muscle stretching, deep breathing, PMR, imagery; Session 2: Development trigger management strategy; Use early warning signs as a cue to use behavioral migraine management and acute medication; Session 3:(a) continue with "basic" migraine management skills if these skills have not been mastered;(b) introduce cognitive-behavioral stress-management, if stress is a salient migraine trigger;(c) introduce thermal biofeedback ("hand warming") training with a portable home thermal biofeedback device, if stress is not a notable migraine trigger. Session 4: Review problems using various behavioral migraine management skills; Prepare written migraine management plan; Relapse prevention addressed |
|
|
| Optimal Acute Therapy | Drug | This acute therapy protocol emphasized treatment with a 5-HT1B/D-agonist or triptan. Nonsteroidal anti-inflammatory (NSAID; ibuprofen) and anti-emetic (metoclopramide) medication could be added as needed. The choice of triptans (rizatriptan®, sumatriptan®), the route(s) of triptan administration (oral, nasal spray, subcutaneous injection), and the addition of a NSAID, or anti-emetic were tailored to participant preference, treatment history and acute therapy response. Individualized handouts and a phone call (week 3) of the OAT Run-in were used to help participants evaluate and optimize their acute therapy. |
|
|
Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment. |
| Change from Month 1 to Month 10 |
| Change in Number of Migraine Episodes Per 30 Days at Month 16. | Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary. | Change from Month 1 to Month 16 |
| Change in the Number of Migraine Days Per 30 Days at Month 16 | Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary. | Change form Month 1 to Month 16 |
| Change in Quality of Life at Month 16 | Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment. | Change from Month 1 to Month 16 |
| Westerville |
| Ohio |
| 43081 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | OAT + BMM + PL | Optimal Acute Therapy plus Behavioral Migraine Management plus placebo |
| BG003 | OAT + BMM + Beta-B | Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | OAT + BMM + PL | Optimal Acute Therapy plus Behavioral Migraine Management plus placebo |
| OG003 | OAT + BMM + Beta-B | Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol) |
|
|
|
| Secondary | Change in the Number of Migraine Days Per 30 Days at Month 10 | Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary. | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Posted | Mean | 95% Confidence Interval | Number of days | Change from Month 1 to Month 10 |
|
|
|
|
| Secondary | Change in Quality of Life at Month 10 | Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment. | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Change from Month 1 to Month 10 |
|
|
|
|
| Secondary | Change in Number of Migraine Episodes Per 30 Days at Month 16. | Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary. | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Posted | Mean | 95% Confidence Interval | Number of Migraine Episodes | Change from Month 1 to Month 16 |
|
|
|
|
| Secondary | Change in the Number of Migraine Days Per 30 Days at Month 16 | Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary. | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Posted | Mean | 95% Confidence Interval | Number of Days | Change form Month 1 to Month 16 |
|
|
|
|
| Secondary | Change in Quality of Life at Month 16 | Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment. | Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Change from Month 1 to Month 16 |
|
|
|
|
| 0 |
| 55 |
| 3 |
| EG001 | OAT + Beta-Blocker at Month 5 | Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/Nadolol. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect assessed after dose adjustment(Month 5). | 0 | 53 | 7 |
| EG002 | OAT + BMM + PL at Month 5 | Optimal Acute Therapy + Behavioral Migraine Management(BMM) + Beta-Blocker(Propranolol/Nadolol) Placebo. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect)as assessed after dose adjustment(Month 5). | 0 | 55 | 2 |
| EG003 | OAT + BMM + Beta-Blocker at Month 5 | Optimal Acute Therapy (OAT)+ Behavioral Migraine Management (BMM)+ Beta-Blocker(Propranolol/Nadolol). Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side effect) assessed after dose adjustment(Month 5). | 0 | 69 | 2 |
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| D009422 | Nervous System Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D010666 | Phenylpropionates |
| No |
| Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 122. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 2.0 | Standard Deviation | 1.03 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 122. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 1.5 | Standard Deviation | 1.12 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 122. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 2.1 | Standard Deviation | 1.26 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 106. | > .02 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.5 | Standard Deviation | 1.20 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 108. | >.79 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.1 | Standard Deviation | 1.35 | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | >.02 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.6 | Standard Deviation | 1.43 | 95 | No | Superiority or Other |
| No |
| Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 108. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 1.5 | Standard Deviation | 2.18 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 122. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 6.0 | Standard Deviation | 2.41 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 106. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 1.4 | Standard Deviation | 1.67 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 120. | <.001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 5.9 | Standard Deviation | 2.03 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 122. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 4.5 | Standard Deviation | 1.83 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 106. | >.87 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.1 | Standard Deviation | 2.38 | 95 | No | Superiority or Other |
Post-test contrast. Mean difference in change. |
| t-test, 2 sided |
Degrees of freedom = 1 and 106. |
| > .83 |
Bonferoni adjusted critical value p = .0083. |
| Mean Difference (Net) |
| 0.0 |
| Standard Deviation |
| 0.79 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 108. | > .05 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.2 | Standard Deviation | 0.67 | 2-Sided | 95 | No | Superiority or Other |
| Significant post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 122. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 1.1 | Standard Deviation | 0.86 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 120. | <.001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 1.3 | Standard Deviation | 0.95 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 106. | > .20 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.2 | Standard Deviation | 0.89 | 2-Sided | 95 | No | Superiority or Other |
Post-test contrast. Mean difference in change. |
| t-test, 2 sided |
Degrees of freedom = 1 and 120. |
| <.001 |
Bonferoni adjusted critical value p = .0083. |
| Mean Difference (Net) |
| 1.6 |
| Standard Deviation |
| 1.96 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 122. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 2.0 | Standard Deviation | 1.69 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 106. | >.04 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.6 | Standard Deviation | 1.69 | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 108. | >0.33 | Bonerfoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.2 | Standard Deviation | 1.34 | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 106. | >0.21 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.2 | Standard Deviation | 1.68 | 95 | No | Superiority or Other |
Post-test contrast. Mean difference in change. |
| t-test, 2 sided |
Degrees of freedom = 1 and 122. |
| < .001 |
Bonferoni adjusted critical value p = .0083. |
| Mean Difference (Net) |
| 6.7 |
| Standard Deviation |
| 3.29 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 122. | < .001 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 5.6 | Standard Deviation | 2.99 | 2-Sided | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 106. | >0.56 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.3 | Standard Deviation | 2.85 | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 108. | >0.08 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 0.8 | Standard Deviation | 2.45 | 95 | No | Superiority or Other |
| Post-test contrast. Mean difference in change. | t-test, 2 sided | Degrees of freedom = 1 and 106. | >0.03 | Bonferoni adjusted critical value p = .0083. | Mean Difference (Net) | 1.1 | Standard Deviation | 2.83 | 95 | No | Superiority or Other |