Effect of an intensive 3-day social cognitive treatment (can do treatment) on control self-efficacy in patients with relapsing remitting multiple sclerosis and low disability: A single-centre randomized controlled trial.

In patients with chronic disorders, control self-efficacy is the confidence with managing symptoms and coping with the demands of illness. Can do treatment (CDT) is an intensive, 3-day, social cognitive theory-based, multidisciplinary treatment that focuses on identification of stressors, goal setting, exploration of boundaries, and establishment of new boundaries. An uncontrolled study showed that patients with relapsing remitting multiple sclerosis (RRMS) and low-disability had improved control self-efficacy six months after CDT. Hence, in a 6-month, single-centre, randomized (1:1), unmasked, controlled trial in RRMS patients with Expanded Disability Status Scale (EDSS) score ≤4.0, we compared CDT with no intervention and the option to receive CDT after completion of study participation. Follow-up assessments were at one, three and six months. Primary endpoint was control self-efficacy (Multiple Sclerosis Self-Efficacy Scale Control [MSSES-C] (minimum 90, maximum 900) at six months. Secondary endpoints were functional self-efficacy (MSSES-F), participation and autonomy (Impact on Participation and Autonomy questionnaire [IPA]), health-related quality of life (MS Quality of Life-54 Items questionnaire [MSQoL-54]), anxiety, depression (Hospital Anxiety and Depression Scale [HADS]) and coping skills (Utrecht Coping List [UCL]) at six months. Tertiary endpoint was care-related strain on support partners (Caregiver Strain Index) at six months. Of the 158 patients that were included, 79 were assigned to CDT and 79 to the control group. Two CDT patients discontinued treatment prematurely. Sixty-one (77%) control patients chose to receive CDT after study participation. Intention-to-treat ANCOVA analyses were performed with follow-up values as dependent, and condition, baseline values, disease duration and gender as independent variables. The mean (standard deviation [SD]) MSSES-C score in the CDT group vs. control group at baseline was 468 (162) vs. 477 (136), and at six months 578 (166) vs. 540 (135) (p = 0.100). Secondary and tertiary endpoints did not differ between groups, except for the UCL palliative reaction score being slightly higher in the CDT group (p = 0.039). On post hoc analyses the MSSES-C score at one and three months was higher in the CDT vs. control group: 597 (114) vs. 491 (131) (p<0.0001) and 561 (160) vs. 514 (143) (p = 0.018), respectively; and at one month the MSSES-F, IPA Limitations, HADS Anxiety and Depression, and MSQoL-54 Mental and Physical scores were also in favour of the CDT group. We conclude that in low-disability RRMS patients, the intensive 3-day social cognitive theory-based CDT did not improve control self-efficacy at six months follow-up compared to waitlist controls. The absence of a between-group difference at six months relates to a gradual improvement in the control group. In all, this social cognitive theory-based approach for improving self-efficacy needs further investigation before being broadly applied in RRMS patients.

An economic evaluation attached to a single-centre, parallel group, unmasked, randomized controlled trial of a 3-day intensive social cognitive treatment (can do treatment) in patients with relapsing remitting multiple sclerosis and low disability.

Aims: This trial-based economic evaluation (EE) assesses from a societal perspective the cost-effectiveness of an intensive 3-day cognitive theory-based intervention (CDT), compared to care-as-usual, in patients with relapsing remitting multiple sclerosis (RRMS) and low disability (Expanded Disability Status Scale [EDDS] score < 4.0). Materials and methods: The trial of the EE was registered in the Dutch Trial Register: Trial NL5158 (NTR5298). The incremental cost-effectiveness ratio (ICER) was expressed in cost on the Control sub-scale of the Multiple Sclerosis Self-Efficacy Scale (MSSES) and the incremental cost-utility ratio (ICUR) in the cost per Quality Adjusted Life Years (QALY) using the EQ-5D-5L. Bootstrap, sensitivity, and sub-group analyses were performed to determine the robustness of the findings. Results: The two groups of 79 patients were similar in baseline characteristics. The base case ICER is situated in the northeast quadrant (€72 (40.74/€2,948)) due to a higher MSSES Control score and higher societal costs in the CDT group. The ICUR is situated in the northwest (inferior) quadrant due to losses in QALY and higher societal costs for the CDT group (-0.02/€2,948). Overall, bootstrap, sensitivity, and sub-group analyses confirm the base case findings. However, when the SF-6D is used as a study outcome, there is a high probability that the ICUR is situated in the northeast quadrant. Limitations: The relative short follow-up time (6 months) and the unexpected increase in MSSES Control in the control group. Conclusions: When using the EQ-5D-5L to calculate a QALY, CDT is not a cost-effective alternative in comparison to care as usual. However, when using self-efficacy or SF-6D as outcomes, there is a probability that CDT is cost-effective. Based on the current results, CDT for patients with RRMS clearly show its potential. However, an extended follow-up for the economic evaluation is warranted before a final decision on implementation can be made.

Intensive social cognitive treatment (can do treatment) with participation of support partners in persons with relapsing remitting multiple sclerosis: observation of improved self-efficacy, quality of life, anxiety and depression 1 year later.

BACKGROUND: In persons with multiple sclerosis (MS) self-efficacy positively affects health-related quality of life (HRQoL) and physical activity. In a previous study we observed that 6 months after an intensive 3-day social cognitive treatment (Can Do treatment) with the participation of support partners, self-efficacy and HRQoL had improved in persons with relapsing remitting MS (RRMS). Given the chronic nature of the disease, it is important to know whether these beneficial changes may last. METHODS: Can Do treatment was given to 60 persons with MS and their support partners. At baseline and 12 months after treatment self-efficacy control, self-efficacy function, physical and mental HRQoL, anxiety, depression and fatigue were assessed via self-report questionnaires. Differences were tested via a paired t test. RESULTS: Of the 57 persons with MS that completed the baseline assessment and the 3-day treatment, 38 filled in the 12th month questionnaires (response rate 66.7 %), 22 with RRMS and 14 with progressive MS. In the RR group self-efficacy control had increased by 20.2 % and physical HRQoL by 15.0 %, and depression and anxiety had decreased by 29.8 and 25.9 %, respectively (all P < 0.05); the changes in mental HRQoL (+17 %) and fatigue (-20 %) failed to be statistically significant (P = 0.087, P = 0.080, respectively). In the progressive group no changes suggestive of improvement were seen. CONCLUSIONS: The findings suggest that a 3-day intensive social cognitive treatment (Can Do treatment) with the participation of support partners may have long lasting beneficial effects on the self-efficacy and HRQoL in persons with RRMS; and that improvements in anxiety and depression, not seen in the 6-month study, may yet develop at 12 months.

An intensive social cognitive program (can do treatment) in people with relapsing remitting multiple sclerosis and low disability: a randomized controlled trial protocol.

BACKGROUND: In people with multiple sclerosis (MS) disabilities and limitations may negatively affect self-efficacy. Lowered self-efficacy has been associated with decreases in health-related quality of life, physical activity and cognitive performance. In an explorative observational study we found that a 3-day intensive social cognitive program (Can Do Treatment [CDT]) with the participation of support partners was followed by substantial increases in self-efficacy control and health-related quality of life 6 months after treatment in those people with MS who had relapsing remitting disease and low disability. METHODS/DESIGN: CDT is a sociologically oriented approach, its goal is to uncover and promote existing capabilities, and the notion "stressor" is the central concept. CDT's components are plenary group sessions, small group sessions, consultations, a theatre evening, and start of the day with a joint activity. The small group sessions form the actual training. Depending on their individual goals the participants join the training groups 'Body', 'Feeling' or 'Life', to work out their aims and to reduce their stressors. The multidisciplinary team includes a psychiatrist, psychiatric nurse, neurologist, specialized MS nurse, physiotherapist, dance therapist, and a person with MS. To evaluate the (cost)effectiveness of CDT in persons with relapsing remitting MS and low disability we perform a single-centre, randomized controlled trial in 140 patients, with or without support partners. The primary outcome is self-efficacy control. The secondary outcomes are self-efficacy function, health-related quality of life, autonomy and participation, anxiety, depression, cost effectiveness and cost utility. The tertiary outcome is care-related strain to support partners. Outcomes are assessed at baseline and at 1, 3 and 6 months after CDT. DISCUSSION: This randomized controlled trial will adequately evaluate the clinical and cost effectiveness of a 3-day intensive social cognitive program in people with relapsing remitting MS and low disability, with self-efficacy control as primary outcome. DUTCH TRIAL REGISTRY: Application number: 22444.

Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study.

BACKGROUND: For persons with multiple sclerosis (MS) it is important to preserve their autonomy, in spite of increasing disability. A major factor mediating autonomy is self-efficacy. According to the social cognitive theory stressors are crucial determinants of self-efficacy, as well as the interaction with partners. METHODS: In an explorative observational study we assessed in 47 persons with MS (PwMS) the effect of an intense, multidisciplinary, 3-day, social cognitive wellness program with the participation of support partners, after 1, 3 and 6 months. PRIMARY OUTCOMES: self-efficacy-control and -function (Multiple Sclerosis Self-Efficacy Scale [MSSES]),limitations to and problems with participation and autonomy (Impact on Participation and Autonomy [IPA] scale). SECONDARY OUTCOMES: health-related quality of life (HRQoL) (MS Quality of Life-54 Items [MSQoL-54] questionnaire), anxiety, depression (Hospital Anxiety and Depression Scale [HADS]), and fatigue (Modified Fatigue Impact Scale-5 Items [MFIS-5]). Disability was measured with the Expanded Disability Status Scale (EDSS). Percentage changes from baseline were tested with T-tests, level of significance 0.05. RESULTS: In the whole group the MSQoL-54 Mental score was increased at 1, 3 and 6 months (+16.0%, +13.2%, +12.2%), and the MSQoL-54 Physical (+10.2%) at 6 months, with no changes in other outcomes. The relapsing remitting (RR) subgroup (n = 20) had at 6 months an increase in the MSSES-Control score (+24.8%) and in the MSQoL54 Mental and Physical scores (+22.3%, +17.6%). Progressive patients (n = 22) only showed an increase in the MSQoL-54 Mental score (+11.5%) at 1 month. In the low-disability (EDSS < 4.0) subgroup the MSSES-Control score was increased (+23.8%) at 6 months, and the IPA-Limitations and -Problems scores decreased at 3 months (-6.1%, -8.8%); the MSQoL-54 Mental score had increased at 1, 3 and 6 months (+19.3%, +21.5%, +19.3%). In the high-disability (EDSS > =4.0) subgroup no significant changes occurred. CONCLUSIONS: Results from this observational study suggest that 6 months after an intense, 3-day, multidisciplinary, social cognitive wellness program with support partners, PwMS with a RR course or low disability may experience an improved self-efficacy-control and HRQoL.