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.

Improved health-related quality of life, participation, and autonomy in patients with treatment-resistant chronic pain after an intensive social cognitive intervention with the participation of support partners.

Despite the availability of various specific treatments, most patients with chronic pain (CP) consider their pain problem as undertreated. Recently, multiple sclerosis (MS) patients who were given an intensive 3-day social cognitive treatment with the participation of support partners experienced lasting improvements in health-related quality of life (HRQoL) and self-efficacy. In this study, a similar intervention was given to treatment-resistant CP patients with stressors, relational problems with support partner, and distress, anxiety or depression. Before and 1, 3, and 6 months after the intervention, patients completed the Euro-Qol 5 Dimensions 5 Levels (EQ-5D-5L) and Impact on Participation and Autonomy (IPA) questionnaires (primary outcomes), and the Survey Of Pain Attitudes (SOPA), the Four-Dimensional Symptom Questionnaire (4DSQ) (distress, depression, anxiety, and somatization), and Visual Analog Scale for pain intensity, whereas the support partners completed the Caregiver Strain Index (CSI) questionnaire. Differences between baseline and post-treatment were tested via paired t-tests (significance level 0.05). Of the 39 patients who were included, 34 (87.2%) completed the 3-day treatment. At 1, 3, and 6 months, improvements were seen in EQ-5D-5L-Index (+40.6%; +22.4%; +31.7%), Health Today (+61.8%; +36.3%; +46.8%), Control attitude (+45.8%; not significant [NS]; +55.0%) and decreases in IPA-Problems (-14.8%; NS; -20.4%), Harm attitude (-18.9%; -15.0%; -17.7%), Distress (-17.7%; -31.8%; -37.1%), and Depression (-37.4%; -31.4%; -35.7%) scores. The CSI score had decreased by -29.0%, -21.4%, and -25.9%, respectively. In conclusion, after an intensive 3-day social cognitive intervention, treatment-resistant CP patients experienced substantial and lasting improvements in HRQoL and in problematic limitations to participation and autonomy, in association with improvements in pain attitudes, depression, and distress. To assess whether this innovative approach may be an effective treatment for this subgroup of CP patients, future randomized controlled studies are needed.

Daily hassles reported by Dutch multiple sclerosis patients.

There is growing evidence for the association between stress and relapse risk in multiple sclerosis (MS). The current study focuses on daily hassles, which by their chronic and accumulating nature can cause considerable psychosocial stress. The main aim was to investigate the frequency, associated distress and type of daily hassles encountered by Dutch MS patients from a large community-based sample. We further examined factors associated with high levels of psychosocial stress. Questionnaires concerning demographics, disease characteristics, physical functioning, daily hassles, fatigue, depression and anxiety were completed by 718 MS patients. Three patients younger than 18 were excluded, resulting in 715 patients. Compared with published norm data, more than 50% of the participants reported a high number of daily hassles (57.5%) and high levels of associated distress (55.7%). Frequently mentioned daily hassles concern personal functioning and social developments. A logistic regression model revealed that being female, being younger, having a higher educational level, using benzodiazepines, exhibiting more symptoms of anxiety, and a higher physical impact of fatigue were all independently associated with high levels of psychosocial stress. Our findings may alert clinicians of the high prevalence and impact of daily hassles in MS and underline the need to incorporate stress and anxiety management strategies in (psycho)therapeutic interventions.