Emma H. Collette

Value of health-related quality of life to predict disability course in multiple sclerosis

Objective: To determine the value of health-related quality of life (HRQoL) to predict change in disability status in patients with multiple sclerosis (MS). Methods: Over a 5-year period, data were collected on HRQoL (Medical Outcomes Study Short Form-36 Health Survey) and disability status (Expanded Disability Status Scale) from a heterogeneous group of 81 Dutch-speaking patients with MS. Results: Multivariate logistic regression analysis showed that HRQoL in the domains of Physical Functioning and Role-Physical Functioning is a significant predictor of change in disability status. Conclusions: A patient’s subjectively perceived health-related quality of life may not be only a clinically and psychosocially meaningful outcome per se but may also be a predictor of objective outcomes such as change in disability status over a substantial period of time.

Effectiveness of cognitive behavioral therapy for the treatment of fatigue in patients with multiple sclerosis: A systematic review and meta-analysis

BACKGROUND Fatigue is a frequently occurring symptom of multiple sclerosis (MS) that limits social participation. OBJECTIVE To systematically determine the short and long-term effects of cognitive behavioral therapy (CBT) for the treatment of MS-related fatigue. DATA SOURCES Pubmed, Cochrane, EMBASE, Psychology and Behavioral Sciences Collection, ERIC, PsychINFO, Cinahl, PsycARTICLES, and relevant trial registers were searched up to February 2016. In addition, references from retrieved articles were examined. STUDY SELECTION Studies were included if participants had MS, fatigue was a primary outcome measure, the intervention was CBT, and the design was a randomized controlled trial. The search was performed by two independent reviewers, three CBT experts determined whether interventions were CBT. DATA EXTRACTION Data on patient and study characteristics and fatigue were systematically extracted using a standardized data extraction form. Two independent reviewers assessed risk of bias using the Cochrane Collaboration risk of bias tool. In the event of disagreement, a third reviewer was consulted. DATA SYNTHESIS Of the 994 identified studies, 4 studies were included in the meta-analysis, comprising 193 CBT-treated patients and 210 patients who underwent a control treatment. Meta-analyses of these studies showed that CBT treatment had a positive short-term effect on fatigue (standardized mean difference [SMD]=-0.47; 95% confidence interval [CI]=-0.88; -0.06; I2=73%). In addition, three studies showed a long-term positive effect of CBT (SMD=-0.30; CI -0.51; -0.08; I2=0%). CONCLUSIONS This review found that the use of CBT for the treatment of fatigue in patients with MS has a moderately positive short-term effect. However, this effect decreases with cessation of treatment.

Feasibility and outcome of a web-based self-help intervention for depressive symptoms in patients with multiple sclerosis: A pilot study

BACKGROUND Depressive symptoms are highly prevalent among patients with multiple sclerosis (MS). Web-based problem solving therapy (PST) is easily accessible and showed to be effective in depressed patients. OBJECTIVES The aims of this pilot study were to examine feasibility and outcome (reduction of depressive symptoms) of an applied web-based PST intervention in MS patients. METHODS Forty-four MS patients with mild to severe depressive symptoms followed a web-based PST intervention. Feasibility was measured by compliance rate and satisfaction scales. The Beck Depression Inventory (BDI-II) was used to measure depressive symptoms before and after the intervention. RESULTS The compliance rate was 52%, and 85% of the patients rated the quality of the intervention as good or excellent. After the intervention, depressive symptoms had significantly decreased (BDI-II change: mean=-3.9, p=0.01, d=0.51 in intention-to-treat analysis; BDI-II change: mean=-9.0, p<0.001, d=1.50 in completers analysis). CONCLUSIONS This study suggests that applied web-based PST is feasible and reduces depressive symptoms in MS patients. Especially MS patients who experience disease-related or other barriers to participate in face-to-face counselling could benefit. However, ways to increase compliance should be considered. A randomized controlled trial is recommended to more extensively investigate effectiveness of this intervention in treating depressive symptoms in MS patients.

Development of a Cognitive Behavioral Group Intervention Programme for Patients with Multiple Sclerosis: An Exploratory Study

A substantial group of patients with multiple sclerosis (MS) has difficulty coping with their disease. Cognitive behavioral group interventions may help these patients cope more effectively with MS. We developed an 8-session group intervention programme for patients recently diagnosed with MS to help them cope more effectively with MS and to overcome negative thoughts and beliefs about the disease to improve health-related quality of life. We tested the feasibility of the group intervention programme and health-related quality of life in a sample of 11 patients recently diagnosed with MS [mean age: 38 (±7.9) yr.; 8 women and 3 men]. All patients were recruited through direct referral by their neurologist or by an MS nurse specialist. The programme was conducted in two small groups of 7 patients each, and each group was led by two psychologists. Cognitive behavioral therapy was an important ingredient in each group session as well as sharing of personal experiences and discussing homework assignments. Each session was formatted the same way but addressed a different MS-specific theme, for example, ‘coping with physical impairments’ or ‘communication with medical staff’. Participants experienced a significant improvement in the health-related quality of life domains of psychological status and vitality, as measured by subscales of Disability and Impact Profile and the Short Form-36 Health Survey. Although further studies are warranted, it appears that a short group intervention programme based on cognitive behavioral techniques for patients with MS might have a positive influence on health-related quality of life.

Internet-based self-help treatment for depression in multiple sclerosis: study protocol of a randomized controlled trial

BackgroundDepression in MS patients is frequent but often not treated adequately. An important underlying factor may be physical limitations that preclude face-to-face contact. Internet-based treatment showed to be effective for depressive symptoms in general and could thus be a promising tool for treatment in MS.Methods/designHere, we present a study protocol to investigate the effectiveness of a 5 week Internet-based self-help problem solving treatment (PST) for depressive symptoms in MS patients in a randomized controlled trial. We aim to include 166 MS patients with moderate to severe depressive symptoms who will be randomly assigned to an Internet-based intervention (with or without supportive text-messages) or waiting list control group. The primary outcome is the change in depressive symptoms defined by a change in the sum score on the Beck Depression Inventory (BDI-II). Secondary outcomes will include measures of anxiety, fatigue, cognitive functioning, physical and psychological impact of MS, quality of life, problem solving skills, social support, mastery, satisfaction and compliance rate. Assessments will take place at baseline (T0), within a week after the intervention (T1), at four months (T2) and at ten months follow-up (T3: only the intervention group). The control group will be measured at the same moments in time. Analysis will be based on the intention-to-treat principle.DiscussionIf shown to be effective, Internet-based PST will offer new possibilities to reach and treat MS patients with depressive symptoms and to improve the quality of care.Trial RegistrationThe Dutch Cochrane Center, NTR2772

Cognitive behavioral therapy positively affects fatigue in patients with multiple sclerosis: Results of a randomized controlled trial

Background: Fatigue is a common symptom in multiple sclerosis (MS) and often restricts societal participation. Cognitive behavioral therapy (CBT) may alleviate MS-related fatigue, but evidence in literature is inconclusive. Objective: To evaluate the effectiveness of CBT to improve MS-related fatigue and participation. Methods: In a multi-center, assessor-masked, randomized controlled trial, participants with severe MS-related fatigue were assigned to CBT or control treatment. CBT consisted of 12 individual sessions with a psychologist trained in CBT, the control treatment consisted of three consultations with a MS nurse, both delivered over 16 weeks. Assessments were at baseline, 8, 16 (i.e. post-intervention), 26, and 52 weeks post-baseline. Primary outcomes were the Checklist Individual Strength-fatigue subscale (CIS20r fatigue) and the Impact on Participation and Autonomy questionnaire (IPA). Data were analyzed according to the intention-to-treat principle, using mixed-model analysis. Results: Between 2011 and 2014, 91 patients were randomized (CBT: n = 44; control: n = 47). Between-group analysis showed a positive post-intervention effect for CBT on CIS20r fatigue (T16: −6.7 (95% confidence interval (CI) = −10.7; −2.7) points) that diminished during follow-up (T52: 0.5 (95% CI = −3.6; 4.4)). No clinically relevant effects were found on societal participation. Conclusion: Severe MS-related fatigue can be reduced effectively with CBT in the short term. More research is needed on how to maintain this effect over the long term.

Body awareness training in the treatment of wearing-off related anxiety in patients with Parkinson's disease : Results from a pilot randomized controlled trial

BACKGROUND In Parkinsons disease (PD) patients, fluctuations in symptoms commonly occur after many years of dopamine replacement therapy. The so-called wearing-off phenomenon exists of both motor and non-motor symptoms, such as rigidity and anxiety. Current treatment options are limited and an integrated approach is needed to address the complex interactions between motor and non-motor symptoms. Since wearing-off is eventually inevitable, treatment needs to focus on coping, acceptance and self-efficacy. We developed the body awareness training, named BEWARE, combining physical therapy with acceptance and commitment therapy to help PD patients deal better with wearing-off related anxiety (WRA). METHODS This was an investigator-blinded randomized controlled trial. Forty PD patients with WRA were randomly assigned to the BEWARE or to the treatment as usual (TAU) condition. Assessments were performed prior to and immediately after the treatment period, and at 3-months follow up. The primary outcome was self-efficacy, secondary outcomes focused on mobility, daily functioning, anxiety, depression and quality of life. RESULTS There was no significant improvement in self-efficacy in the BEWARE treatment condition when compared to TAU. However, standing balance and emotional wellbeing showed a significant improvement, and feelings of stigmatization showed a trend-significant decrease in the BEWARE condition. CONCLUSIONS We consider the BEWARE training to be a promising therapeutic approach to address WRA. Improvement points from the participants included 1) less frequent but longer therapy sessions; 2) active involvement of caregivers; and 3) the development of a supportive workbook. The optimized treatment protocol needs further evaluation in a phase III RCT. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02054845.

BEWARE: Body awareness training in the treatment of wearing-off related anxiety in patients with Parkinson's disease: study protocol for a randomized controlled trial.

BackgroundThe wearing-off phenomenon in patients with Parkinson’s disease (PD) is a complication of prolonged levodopa usage. During this phenomenon, motor symptoms such as rigidity and freezing re-emerge. This is often accompanied by non-motor symptoms, including anxiety, the so-called wearing-off related anxiety (WRA). Current treatment options are limited and typically focus on either the physical or mental aspects of wearing-off. An integrated approach seems warranted in order to optimally address the complex reciprocal interactions between these aspects. Also, because wearing-off is eventually inescapable, treatment needs to focus on coping, acceptance, and self-efficacy. We therefore developed an integrated body awareness intervention, combining principles from physical therapy with acceptance and commitment therapy to teach patients to deal with WRA. This study will investigate whether this new intervention, named BEWARE, is more effective than treatment as usual in increasing self-efficacy.Methods/DesignThis is a single-blinded randomized controlled trial in 36 PD patients who experience WRA. Subjects will be recruited from the outpatient clinic for movement disorders of the VU University Medical Center. After providing written informed consent, patients will be randomly assigned to an experimental (BEWARE) or treatment-as-usual (physical therapy) group. Clinical assessments will be performed prior to the intervention, directly after the 6-week intervention period, and at 3-month naturalistic follow-up by a blinded investigator not involved in the study. The primary outcome measure is self-efficacy, and secondary outcomes focus on mobility, daily functioning, anxiety, and quality of life.DiscussionBecause wearing-off is an inevitable consequence of levodopa therapy and current treatment options are insufficient, a multidisciplinary intervention that addresses both physical and mental aspects of wearing-off in PD may foster additional benefits for treating WRA in PD patients over mono-disciplinary care alone.Trial registrationClinicalTrials.gov identifier: NCT02054845. Date of registration: 30 January 2014.

Real-Time Assessment of Fatigue in Patients With Multiple Sclerosis: How Does It Relate to Commonly Used Self-Report Fatigue Questionnaires?

OBJECTIVES (1) To assess real-time patterns of fatigue; (2) to assess the association between a real-time fatigue score and 3 commonly used questionnaires (Checklist Individual Strength [CIS] fatigue subscale, Modified Fatigue Impact Scale (MFIS), and Fatigue Severity Scale [FSS]); and (3) to establish factors that confound the association between the real-time fatigue score and the conventional fatigue questionnaires in patients with multiple sclerosis (MS). DESIGN Cross-sectional study. SETTING MS-specialized outpatient facility. PARTICIPANTS Ambulant patients with MS (N=165) experiencing severe self-reported fatigue. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES A real-time fatigue score was assessed by sending participants 4 text messages on a particular day (How fatigued do you feel at this moment?; score range, 0-10). Latent class growth mixed modeling was used to determine diurnal patterns of fatigue. Regression analyses were used to assess the association between the mean real-time fatigue score and the CIS fatigue subscale, MFIS, and FSS. Significant associations were tested for candidate confounders (eg, disease severity, work status, sleepiness). RESULTS Four significantly different fatigue profiles were identified by the real-time fatigue score, namely a stable high (n=79), increasing (n=57), stable low (n=16), and decreasing (n=13). The conventional questionnaires correlated poorly (r<.300) with the real-time fatigue score. The Epworth Sleepiness Scale significantly reduced the regression coefficient between the real-time fatigue score and conventional questionnaires, ranging from 15.4% to 35%. CONCLUSIONS Perceived fatigue showed 4 different diurnal patterns in patients with MS. Severity of sleepiness is an important confounder to take into account in the assessment of fatigue.

Internet-based treatment for depression in multiple sclerosis: a randomized controlled trial.

Background: Depression in multiple sclerosis (MS) patients is common but may stay untreated. Physical limitations impede face-to-face treatment. Internet-based treatment is therefore a promising tool for treating depression in MS. Objectives: To investigate effectiveness of a guided Internet-based problem-solving treatment (IPST) for depressed MS patients. Methods: MS patients with moderate or severe depressive symptoms were randomly assigned to IPST or a wait list control. Primary outcome was the change in depressive symptoms defined by a change in sum score on the Beck Depression Inventory Second Edition (BDI-II). Assessments took place at baseline (T0), within a week after the intervention (T1), and at 4 months follow-up (T2). Analyses were based on the intention-to-treat principle. Results: A total of 171 patients were randomized to IPST (n = 85) or a wait list control (n = 86). T1 was completed by 152 (89%) and T2 by 131 patients (77%). The IPST group and wait list control showed large significant improvements in depressive symptoms, but no differences were found between groups at T1 (d = 0.23; 95% confidence interval (CI) = (−4.03, 1.08); p = 0.259) and T2 (d = 0.01; 95% CI = (−2.80, 2.98); p = 0.953). Conclusion: We found no indication that IPST for MS patients with moderate or severe depression is effective in reducing depressive symptoms compared to a waiting list. Large improvements in the wait list control were unexpected and are discussed.