Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine the effects of different treatment locations using repetitive transcranial magnetic stimulation (rTMS) to treat major depressive disorder.
Currently there is little standardization between rTMS treatment programs as to what is the best way to localize the left dorsolateral prefrontal cortex, which is the FDA-approved treatment location for clinical rTMS for major depressive disorder (MDD). Different targeting methods yield locations that can vary by up to a few centimeters. By comparing different treatment locations and obtaining neurobehavioral, neuroimaging, cognitive, and neuropsychological measures, this study would provide the opportunity to identify the optimal treatment targeting method when using rTMS for major depressive disorder in a clinical setting. This study will specifically be focusing on comparing the two most common targeting methods: a target 5.5cm anterior to the motor strip on the left prefrontal scalp and the F3 target location on the left prefrontal scalp as identified using the 10-20 EEG system nomenclature.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5.5cm Rule Group | Active Comparator | rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing. |
|
| F3 Group | Active Comparator | rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation | Device | Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Patient Health Questionnaire 9-Item Assessment Score | Overall change in total Patient Health Questionnaire 9-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assessment measures depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms. | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
| Percentage Change in Montgomery-Asberg Depression Rating Scale Score | Overall change in total Montgomery-Asberg Depression Rating Scale score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This scale assesses depression severity at baseline. Scores of 8, 17, and 34 are cut-off points for mild, moderate, severe depression, respectively. This 10 item scale is summed to compute a total score, ranging from 0-60. Higher scores indicate more severe clinician-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms. | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
| Percentage Change in General Anxiety Disorder 7-Item Assessment Score | Overall change in total General Anxiety Disorder 7-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assesses anxiety severity as baseline. Scores of 5, 10, and 15 are cut-off points for mild, moderate, and severe anxiety, respectively. All 7 items are summed to compute a total score, ranging from 0-21. Higher scores indicate more severe self-rated anxiety symptoms. Negative change from baseline implies a decrease in anxiety symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment Score Changes | Change in Montreal Cognitive Assessment scores from baseline to final timepoint. Reported here as the mean difference in total Montreal Cognitive Assessment score from baseline to endpoint. Montreal Cognitive Assessment is used a screen for cognitive impairment, calculated by adding the points from each task, which range from 0-30. Higher scores indicate little to no cognitive impairment 26 or above: Normal cognition 18-25: Mild cognitive impairment 10-17: Moderate cognitive impairment Fewer than 10: Severe cognitive impairment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicholas T Trapp, M.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37714408 | Derived | Trapp NT, Pace BD, Neisewander B, Ten Eyck P, Boes AD. A randomized trial comparing beam F3 and 5.5 cm targeting in rTMS treatment of depression demonstrates similar effectiveness. Brain Stimul. 2023 Sep-Oct;16(5):1392-1400. doi: 10.1016/j.brs.2023.09.006. Epub 2023 Sep 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2 subjects withdrew before randomization 12 subjects were excluded due to head circumference >60cm 2 refused randomization 2 subjects were not randomized for an unspecified reason
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 5.5cm Rule Group | rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing. Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments. |
| FG001 | F3 Group | rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system. Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 5.5cm Rule Group | rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing. Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Patient Health Questionnaire 9-Item Assessment Score | Overall change in total Patient Health Questionnaire 9-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assessment measures depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms. | Posted | Mean | Standard Error | percentage of change from baseline | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
|
During the course of TMS treatment (approx. 4-6 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5.5cm Rule Group | rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing. Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicholas Trapp | University of Iowa Hospitals & Clinics | (319) 467-8188 | nicholas-trapp@uiowa.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2019 | Dec 6, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 22, 2019 | Dec 6, 2023 | SAP_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
| Response and Remission Rates on Patient Health Questionnaire 9-Item Assessment | Comparison of the response rate (>50% improvement) and remission rate (score <5) for the Patient Health Questionnaire 9-Item Assessment between the 2 groups post-treatment. | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
| Response and Remission Rates on Montgomery-Asberg Depression Rating Scale | Comparison of the response rate (>50% improvement) and remission rate (score <10) for the MADRS between the 2 groups post-treatment. | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
| Response Rates on General Anxiety Disorder 7-Item Assessment | Comparison of the response rate (>50% improvement) for the General Anxiety Disorder 7-Item Assessment between the 2 groups post-treatment. | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
| Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
| Emotion Measures | T Score Changes in National Institutes of Health Toolbox Emotional Battery A T score of 50 corresponds to the population mean. Scores may range from 20-80 with a standard deviation of 10. Higher T scores indicate a higher endorsement of each domain. Here, we present changes in mean score from pre-treatment to post-treatment. In that way, a positive value represents a decrease in average T score, and vice versa. | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
| BG001 | F3 Group | rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system. Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Comorbidities | Number | participants |
|
| Psychiatric Medications | Number of participants that self-reported medication trials in the reported categories in the current major depressive episode | Count of Participants | Participants |
|
| Number of Medication Trials | Count of self-reported medication trials that either were not tolerable or did not reduce severity of symptoms in the current major depressive episode | Mean | Standard Deviation | medications |
|
| Patient Health Questionnaire 9-Item Assessment | This assesses depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. | Mean | Standard Deviation | total score |
|
| General Anxiety Disorder 7-Item Assessment | This assesses anxiety severity as baseline. Scores of 5, 10, and 15 are cut-off points for mild, moderate, and severe anxiety, respectively. All 7 items are summed to compute a total score, ranging from 0-21. Higher scores indicate more severe self-rated anxiety symptoms. | Mean | Standard Deviation | total score |
|
| Montgomery-Asberg Depression Rating Scale | This assesses depression severity at baseline. Scores of 8, 17, and 34 are cut-off points for mild, moderate, severe depression, respectively. This 10 item scale is summed to compute a total score, ranging from 0-60. Higher scores indicate more severe clinician-rated depressive symptoms. | Mean | Standard Deviation | total score |
|
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
| OG001 | F3 Group | rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system. Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments. |
|
|
|
| Primary | Percentage Change in Montgomery-Asberg Depression Rating Scale Score | Overall change in total Montgomery-Asberg Depression Rating Scale score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This scale assesses depression severity at baseline. Scores of 8, 17, and 34 are cut-off points for mild, moderate, severe depression, respectively. This 10 item scale is summed to compute a total score, ranging from 0-60. Higher scores indicate more severe clinician-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms. | Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size. | Posted | Mean | Standard Error | percentage of change from baseline | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
|
|
|
|
| Primary | Percentage Change in General Anxiety Disorder 7-Item Assessment Score | Overall change in total General Anxiety Disorder 7-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assesses anxiety severity as baseline. Scores of 5, 10, and 15 are cut-off points for mild, moderate, and severe anxiety, respectively. All 7 items are summed to compute a total score, ranging from 0-21. Higher scores indicate more severe self-rated anxiety symptoms. Negative change from baseline implies a decrease in anxiety symptoms. | Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size. | Posted | Mean | Standard Error | percentage change from baseline | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
|
|
|
|
| Primary | Response and Remission Rates on Patient Health Questionnaire 9-Item Assessment | Comparison of the response rate (>50% improvement) and remission rate (score <5) for the Patient Health Questionnaire 9-Item Assessment between the 2 groups post-treatment. | Posted | Number | percentage of participants | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
|
|
|
|
| Primary | Response and Remission Rates on Montgomery-Asberg Depression Rating Scale | Comparison of the response rate (>50% improvement) and remission rate (score <10) for the MADRS between the 2 groups post-treatment. | Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size. | Posted | Number | percentage of participants | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
|
|
|
|
| Primary | Response Rates on General Anxiety Disorder 7-Item Assessment | Comparison of the response rate (>50% improvement) for the General Anxiety Disorder 7-Item Assessment between the 2 groups post-treatment. | Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size. | Posted | Number | percentage of participants | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
|
|
|
|
| Secondary | Montreal Cognitive Assessment Score Changes | Change in Montreal Cognitive Assessment scores from baseline to final timepoint. Reported here as the mean difference in total Montreal Cognitive Assessment score from baseline to endpoint. Montreal Cognitive Assessment is used a screen for cognitive impairment, calculated by adding the points from each task, which range from 0-30. Higher scores indicate little to no cognitive impairment 26 or above: Normal cognition 18-25: Mild cognitive impairment 10-17: Moderate cognitive impairment Fewer than 10: Severe cognitive impairment | Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size. | Posted | Mean | Standard Deviation | score on a scale | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
|
|
|
|
| Secondary | Emotion Measures | T Score Changes in National Institutes of Health Toolbox Emotional Battery A T score of 50 corresponds to the population mean. Scores may range from 20-80 with a standard deviation of 10. Higher T scores indicate a higher endorsement of each domain. Here, we present changes in mean score from pre-treatment to post-treatment. In that way, a positive value represents a decrease in average T score, and vice versa. | Only a subset of participants completed this task, so total sample size is much smaller. | Posted | Mean | Standard Deviation | T Score | Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later. |
|
|
|
|
| Post-Hoc | Patient Health Questionnaire 9-Item Assessment Linear Mixed Effects Model | An exploratory analysis to investigate between-group differences in trajectory of improvement as measured by group by time interactions. This assessment measures depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms. | All randomized participants were included in this analysis. Weekly timepoints have different ns due to dropouts and/or missing data. | Posted | Mean | Standard Deviation | mean PHQ-9 total score | Baseline to Weeks 1 through 6, assessed weekly |
|
|
|
|
| Post-Hoc | Montgomery-Asberg Depression Rating Scale Linear Mixed Effects Model | An exploratory analysis to investigate between-group differences in trajectory of improvement as measured by group by time interactions. This scale assesses depression severity at baseline. Scores of 8, 17, and 34 are cut-off points for mild, moderate, severe depression, respectively. This 10 item scale is summed to compute a total score, ranging from 0-60. Higher scores indicate more severe clinician-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms. | All randomized participants were included in this analysis. Weekly timepoints have different ns due to dropouts and/or missing data. | Posted | Mean | Standard Deviation | mean MADRS total score | Baseline to biweekly timepoints |
|
|
|
|
| Post-Hoc | General Anxiety Disorder 7-Item Assessment Linear Mixed Effects Model | An exploratory analysis to investigate between-group differences in trajectory of improvement as measured by group by time interactions. This assesses anxiety severity as baseline. Scores of 5, 10, and 15 are cut-off points for mild, moderate, and severe anxiety, respectively. All 7 items are summed to compute a total score, ranging from 0-21. Higher scores indicate more severe self-rated anxiety symptoms. Negative change from baseline implies a decrease in anxiety symptoms. | All randomized participants were included in this analysis. Weekly timepoints have different ns due to dropouts and/or missing data. | Posted | Mean | Standard Deviation | mean GAD-7 total score | Baseline to weekly timepoints |
|
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | F3 Group | rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system. Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments. | 0 | 58 | 0 | 58 | 0 | 58 |
Not provided
Not provided
Not provided
| D001519 |
| Behavior |
| The null hypothesis of this study was that there would be no differences between targets across all measures. A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized. | Chi-squared | 0.888 | p value for remission rate | Other |
| The null hypothesis of this study was that there would be no differences between targets across all measures. A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized. | Chi-squared | p value for remission rates | 0.911 | Other |
| Meaning & Purpose |
|
| Emotional Support |
|
| Instrumental Support |
|
| Friendship |
|
| Loneliness |
|
| Perceived Rejection |
|
| Perceived Hostility |
|
| Self-Efficacy |
|
| Perceived Stress |
|
| Fear-Affect |
|
| Fear-Somatic Arousal |
|
| Sadness |
|
| Anger-Affect |
|
| Anger-Hostility |
|
| Anger-Physical Aggression |
|
| Negative Affect |
|
| Social Satisfaction |
|
| Psychological Well Being |
|
The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, General Life Satisfaction.
| t-test, 2 sided |
| .024 |
| Other |
comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Meaning & Purpose. | t-test, 2 sided | .439 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Emotional Support. | t-test, 2 sided | .025 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Instrumental Support. | t-test, 2 sided | .007 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Friendship. | t-test, 2 sided | .014 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Loneliness. | t-test, 2 sided | .398 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Rejection. | t-test, 2 sided | .064 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Hostility. | t-test, 2 sided | .368 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Self-Efficacy. | t-test, 2 sided | .504 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Stress. | t-test, 2 sided | .371 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Affect. | t-test, 2 sided | .438 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Somatic Arousal. | t-test, 2 sided | .096 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Sadness. | t-test, 2 sided | .132 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Affect. | t-test, 2 sided | .951 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Hostility. | t-test, 2 sided | .852 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Physical Aggression. | t-test, 2 sided | .083 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Negative Affect. | t-test, 2 sided | .391 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Social Satisfaction. | t-test, 2 sided | .014 | Other | comparative effectiveness trial |
| The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Psychological Well Being. | t-test, 2 sided | .109 | Other | comparative effectiveness trial |
| Week 1 |
|
|
| Week 2 |
|
|
| Week 3 |
|
|
| Week 4 |
|
|
| Week 5 |
|
|
| Week 6 |
|
|
| Week 2-3 Follow-up |
|
|
| Week 4-5 Follow-up |
|
|
| Week 6-7 Follow-up |
|
|
| Week 1 |
|
|
| Week 2 |
|
|
| Week 3 |
|
|
| Week 4 |
|
|
| Week 5 |
|
|
| Week 6 |
|
|