Trial Outcomes & Findings for Stress Management for Patients With Multiple Sclerosis (NCT NCT00147446)
NCT ID: NCT00147446
Last Updated: 2013-09-10
Results Overview
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.
COMPLETED
PHASE2
121 participants
week 8 to week 24
2013-09-10
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
COMPLETED
|
60
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stress Management for Patients With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Stress Management Therapy for Multiple Sclerosis
n=60 Participants
Stress management therapy for multiple sclerosis(SMT-MS)at baseline
|
Wait List Control Condition
n=61 Participants
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
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
42.3 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 9.08 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
61 participants
n=7 Participants
|
121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 8 to week 24Population: 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.
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.
Outcome measures
| Measure |
Stress Management Therapy for Multiple Sclerosis
n=60 Participants
Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
|
Wait List Control Condition
n=61 Participants
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
|
|---|---|---|
|
No.of Gd+ Lesions From Week 8 to Week 24
No. of Gd+ lesions(week 8 to week 24), Gd+ = 0
|
46 participants
|
33 participants
|
|
No.of Gd+ Lesions From Week 8 to Week 24
No. of Gd+ lesions(week 8 to week 24), Gd+ = 1
|
5 participants
|
13 participants
|
|
No.of Gd+ Lesions From Week 8 to Week 24
No. of Gd+ lesions(week 8 to week 24), Gd+ = 2
|
2 participants
|
6 participants
|
|
No.of Gd+ Lesions From Week 8 to Week 24
No. of Gd+ lesions(week 8 to week 24), Gd+ = 3
|
2 participants
|
6 participants
|
|
No.of Gd+ Lesions From Week 8 to Week 24
No. of Gd+ lesions(week 8 to week 24), Gd+ >= 4
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: week 8 to week 24T2-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.
Outcome measures
| Measure |
Stress Management Therapy for Multiple Sclerosis
n=60 Participants
Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
|
Wait List Control Condition
n=61 Participants
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
|
|---|---|---|
|
No.of New or Enlarged T2 Lesions From Week 8 to Week 24
No. of T2 lesions (week 8 to week 24), T2 = 0
|
43 participants
|
26 participants
|
|
No.of New or Enlarged T2 Lesions From Week 8 to Week 24
No. of T2 lesions(week 8 to week 24), T2 = 1
|
8 participants
|
9 participants
|
|
No.of New or Enlarged T2 Lesions From Week 8 to Week 24
No. of T2 lesions(week 8 to week 24), T2 = 2
|
1 participants
|
9 participants
|
|
No.of New or Enlarged T2 Lesions From Week 8 to Week 24
No. of T2 lesions(week 8 to week 24), T2 = 3
|
1 participants
|
7 participants
|
|
No.of New or Enlarged T2 Lesions From Week 8 to Week 24
No. of T2 lesions(week 8 to week 24), T2 >=4
|
7 participants
|
10 participants
|
Adverse Events
Stress Management Therapy for Multiple Sclerosis
Wait List Control Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place