Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HD043323 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There is a growing body of literature showing that stressful life events can increase the risk of developing exacerbations and new brain lesions among people with multiple sclerosis. The purpose of this study is to examine the hypothesis that stress management programs can reduce the occurrence of new brain lesions and exacerbations. We will also examine potential immune and neuroendocrine pathways.
MS is a frequently disabling autoimmune disease affecting approximately 350,000 people in the United States. More than two decades of research has consistently shown a relationship between stressful life events (SLEs), in particular non-traumatic family and work stressors, and subsequent clinical exacerbation. Furthermore, we have shown that non-traumatic SLEs increase the risk of the subsequent appearance of new gadolinium enhancing (Gd+) magnetic resonance imaging (MRI) brain lesions, an early marker of MS inflammation and blood-brain barrier (BBB) breakdown. The purpose of this study is to determine the efficacy of cognitive behavioral stress management for MS (CBSM-MS) in reducing the occurrence of new brain lesions in people with relapsing forms of MS. Patients must have a documented new Gd+ MRI brain lesion or clinical exacerbation within the previous 12 months to be enrolled. One hundred and twelve patients will be enrolled for 12 months. Patients will be randomly assigned to either an intensive CBSM-MS program, consisting of 16 individual meetings with a behavioral medicine specialist, or a condensed CBSM-MS program, consisting of a one-day workshop offered after the 10th month of participation. Outcomes include MRI, clinical neurological end-points, and psychosocial functioning. We will also enhance our understanding of mechanisms by examining potential psychosocial, immune, and endocrine mediators of the relationship between SLEs and clinical and neuroimaging markers of MS inflammation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual Stress Management | Experimental | Stress management therapy for multiple sclerosis (SMT-MS) is a manualized, validated, published stress management program designed for patients with MS. Participants met with a therapist for 16 individual 50-minute sessions conducted over 20-24 weeks. The first 6 sessions focused on teaching problem solving skills, relaxation, increasing positive activities, cognitive restructuring, and enhancement of social support. Participants were able to tailor the treatment to meet their needs using optional treatment modules including communication and assertiveness training, fatigue management, anxiety reduction, pain management, management of cognitive problems, insomnia treatment, and management of sexual dysfunction. |
|
| Wait List Control | Other | Wait List Control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluation that were not contaminated by the workshop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual Stress Management | Behavioral | Stress management therapy for multiple sclerosis (SMT-MS) is a manualized, validated, published stress management program designed for patients with MS. Participants met with a therapist for 16 individual 50-minute sessions conducted over 20-24 weeks. The first 6 sessions focused on teaching problem solving skills, relaxation, increasing positive activities, cognitive restructuring, and enhancement of social support. Participants were able to tailor the treatment to meet their needs using optional treatment modules including communication and assertiveness training, fatigue management, anxiety reduction, pain management, management of cognitive problems, insomnia treatment, and management of sexual dysfunction. |
| Measure | Description | Time Frame |
|---|---|---|
| No.of Gd+ Lesions From Week 8 to Week 24 | Gd+ is Gadolinium-enhancing MRI brain lesion, A marker of the opening of the blood-brain barrier and is typically used as a primary endpoints in phase II trials because of its high sensitivity to ongoing MS disease activity and its association with clinical exacerbation. The single value was calculated by summing up the lesions from week 8 to week 24. | week 8 to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| No.of New or Enlarged T2 Lesions From Week 8 to Week 24 | T2-weighted MRI is commonly used in phase II trials to identify more permanent lesions. The single value was calculated by summing up the lesions from week 8 to week 24. | week 8 to week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David C. Mohr, Ph.D. | Northwestern University | Principal Investigator |
| Joyce Ho, PhD | Northwestern University | Study Director |
| David Daikh, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Behavioral Medicine Research Center | San Francisco | California | 94121 | United States | ||
| Northwestern University, Department of Preventive Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22786596 | Background | Mohr DC, Lovera J, Brown T, Cohen B, Neylan T, Henry R, Siddique J, Jin L, Daikh D, Pelletier D. A randomized trial of stress management for the prevention of new brain lesions in MS. Neurology. 2012 Jul 31;79(5):412-9. doi: 10.1212/WNL.0b013e3182616ff9. Epub 2012 Jul 11. | |
| 23680407 | Derived | Burns MN, Nawacki E, Kwasny MJ, Pelletier D, Mohr DC. Do positive or negative stressful events predict the development of new brain lesions in people with multiple sclerosis? Psychol Med. 2014 Jan;44(2):349-59. doi: 10.1017/S0033291713000755. Epub 2013 May 17. |
Not provided
Not provided
Not provided
Participants were enrolled at MS specialty clinics at three sites in the United States (University of California San Francisco California (UCSF), Evergreen Hospital Medical Center in Seattle Washington and the Feinberg School of Medicine at Northwestern University in Chicago Illinois) and through local chapters of the National MS Society.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stress Management Therapy for Mulitple Sclerosis | Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up. |
| FG001 | Wait List Control Condition | Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stress Management Therapy for Multiple Sclerosis | Stress management therapy for multiple sclerosis(SMT-MS)at baseline |
| BG001 | Wait List Control Condition | Wait list control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop |
| 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 | No.of Gd+ Lesions From Week 8 to Week 24 | Gd+ is Gadolinium-enhancing MRI brain lesion, A marker of the opening of the blood-brain barrier and is typically used as a primary endpoints in phase II trials because of its high sensitivity to ongoing MS disease activity and its association with clinical exacerbation. The single value was calculated by summing up the lesions from week 8 to week 24. | A total of 121 patients with relapsing forms of MS were randomized to SMT-MS or WLC. Participants were enrolled at MS specialty clinics at 3 sites in the United States (UCSF; Evergreen Hospital Medical Center, and the Feinberg School of Medicine at Northwestern University, Chicago, Illinois) and through local chapters of the National MS Society. | Posted | Number | participants | week 8 to week 24 |
|
Not provided
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 | Stress Management Therapy for Multiple Sclerosis | Stress management therapy for MS(SMT-MS, provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up. |
Not provided
Not provided
we caution that it is premature to make specific clinical recommendations regarding the use of SMT-MS to manage MS disease-related activity. Future work should identify, refine, and optimize the active ingredients in this behavioral intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David C. Mohr | Northwestern University | 312-503-3128 | m.lisetteluistro@northwestern.edu |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Wait List Control | Other | Wait List Control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluation that were not contaminated by the workshop. |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| MS Center at Evergreen Medical Center | Kirkland | Washington | 98034 | United States |
| 23197840 | Derived | Burns MN, Nawacki E, Siddique J, Pelletier D, Mohr DC. Prospective examination of anxiety and depression before and during confirmed and pseudoexacerbations in patients with multiple sclerosis. Psychosom Med. 2013 Jan;75(1):76-82. doi: 10.1097/PSY.0b013e3182757b2b. Epub 2012 Nov 28. |
| BG002 | 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 |
|
| OG001 | Wait List Control Condition | Wait list control(WLC) provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop |
|
|
|
| Secondary | No.of New or Enlarged T2 Lesions From Week 8 to Week 24 | T2-weighted MRI is commonly used in phase II trials to identify more permanent lesions. The single value was calculated by summing up the lesions from week 8 to week 24. | Posted | Number | participants | week 8 to week 24 |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Wait List Control Condition | Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop | 0 | 61 | 0 | 61 |
Not provided
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| No. of T2 lesions(week 8 to week 24), T2 = 2 |
|
| No. of T2 lesions(week 8 to week 24), T2 = 3 |
|
| No. of T2 lesions(week 8 to week 24), T2 >=4 |
|
It was hypothesized that significantly greater numbers of participants receiving SMT-MS remained free of new T2 lesions during the treatment, compared to control condition participants.
| Logistic Regression |
| 0.006 |
| Odds Ratio (OR) |
| 3.07 |
| 2-Sided |
| 95 |
| 1.38 |
| 6.81 |
| No |
| Superiority or Other |