TY - JOUR
T1 - 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
T2 - A single-centre randomized controlled trial
AU - Jongen, Peter Joseph
AU - van Mastrigt, Ghislaine A
AU - Heerings, Marco
AU - Visser, Leo H
AU - Ruimschotel, Rob P
AU - Hussaarts, Astrid
AU - Duyverman, Lotte
AU - Valkenburg-Vissers, Joyce
AU - Cornelissen, Job
AU - Bos, Michel
AU - van Droffelaar, Maarten
AU - Donders, Rogier
N1 - Funding Information:
The study was initiated, funded and co-executed by the National Multiple Sclerosis Foundation Rotterdam, the Netherlands. The funder provided support in the form of payments to the MS4 Research Institute, Nijmegen, the Netherlands (PJJ, GAvM, RD) and salaries for the authors MH, LHV, RPR, AH, LD, JVV, JC, MB and MvD. The funder did not have any additional role in the study design, data analysis, interpretation of results, decision to publish or preparation of the manuscript. The funder had a role in the recruitment (AH) and screening (MH) of patients, and in the data collection (MH). MS4 Research Institute, Nijmegen, the Netherlands, was commissioned and paid by NMSF, Rotterdam, the Netherlands. The researcher performing the analyses (GAvM) and the statisticians (RD, assigning statistician) were commissioned and paid by MS4 Research Institute, Nijmegen, the Netherlands. The specific roles of the authors are articulated in the Author contributions? section. RPR is co-owner of PsyToBe, Rotterdam, the Netherlands; at the time of the study AH was employed by the NMSF, Rotterdam, the Netherlands, and was thereafter employed by PsyToBe, Rotterdam, the Netherlands; LD is employed by PsyToBe, Rotterdam, the Netherlands; JVV is employed by Fysiotherapie Maaspoort,?s-Hertogenbosch, the Netherlands; JC is owner of Dansjobs, Landsmeer, the Netherlands; at the time of the study MvD was employed by the NMSF, Rotterdam, the Netherlands.
Publisher Copyright:
© 2019 Jongen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2019/10/10
Y1 - 2019/10/10
N2 - 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.
AB - 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.
KW - Adult
KW - Case-Control Studies
KW - Cognitive Behavioral Therapy
KW - Disability Evaluation
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Intention to Treat Analysis
KW - Male
KW - Multiple Sclerosis, Relapsing-Remitting/therapy
KW - Self Efficacy
KW - ANXIETY
KW - VALIDATION
KW - AUTONOMY
KW - PHYSICAL-ACTIVITY
KW - PEOPLE
KW - QUALITY-OF-LIFE
KW - INTERVENTION
KW - PARTICIPATION
U2 - 10.1371/journal.pone.0223482
DO - 10.1371/journal.pone.0223482
M3 - Article
C2 - 31600271
SN - 1932-6203
VL - 14
JO - PLOS ONE
JF - PLOS ONE
IS - 10
M1 - e0223482
ER -