Clinical assessment of emotions in patients with cancer: Diagnostic accuracy compared with two reference standards.

BACKGROUND: Previous research has suggested that clinical assessment of emotions in patients with cancer is suboptimal. However, it is a possibility that well-trained and experienced doctors and nurses do recognize emotions but that they do not evaluate all emotions as necessitating professional mental health care. This implies that the sensitivity of clinical assessment should be tested against the need for professional mental health care as reference standard, instead of emotional distress. We hypothesized that the observed sensitivity of clinical assessment of emotions would be higher when tested against need for professional mental health care as reference standard, compared with emotional distress as reference standard. PATIENTS AND METHODS: A consecutive series of patients starting with chemotherapy were recruited during their routine clinical care, at a department of medical oncology. Clinical assessment of emotions by medical oncologists and nurses was derived from the patient file. Emotional distress and need for professional mental health care were assessed using the Distress Thermometer and Problem List. RESULTS: Clinical assessment resulted in notes on emotions in 42.2% of the patient files with 36.2% of patients experiencing emotional distress and 10.8% expressing a need for professional mental health care (N = 185). As expected, the sensitivity of clinical assessment of emotions was higher with the reference standard "need for professional mental health care" compared with "emotional distress" (P < .001). For specificity, equivalent results were obtained with the two reference standards (P = .63). CONCLUSIONS: Clinical assessment of emotions in patients with cancer may be more accurate than previously concluded.

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.

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.

Enhancing quality of life and mastery of informal caregivers of high-grade glioma patients: a randomized controlled trial.

High-grade gliomas (HGG) are serious primary brain tumors that may prevent the patient from functioning normally in social, emotional and cognitive respect. Often the partner's role will convert to that of informal caregiver. Consequently, they may experience significant stress and reductions in caregiver mastery, negatively affecting their health-related quality of life (HRQOL). We aimed at (1) determining factors that impact HRQOL and mastery of caregivers of HGG patients, and (2) investigate if a structured intervention consisting of psychoeducation and cognitive behavioral therapy leads to improvements in the mental component of HRQOL and mastery of caregivers. Fifty-six patient-caregiver dyads were randomly assigned to the intervention group or the care as usual group. The intervention program consisted of six one-hour sessions with a psychologist. Participants completed questionnaires concerning their perceptions of the patients' HRQOL (SF-36), neurological functioning (BN20), and cognitive functioning (MOS), and concerning their own HRQOL (SF-36) and feelings of caregiver mastery (CMS) both at baseline (i.e. before randomization) and every 2 months thereafter until 8 months later, five times in total. Patients' HRQOL and neurological functioning were found to be related to HRQOL and feelings of mastery of the informal caregiver at baseline. The intervention helped caregivers in maintaining a stable level of HRQOL and improved feelings of mastery over an 8 month period. Our findings suggest that informal caregivers can benefit from a psychological intervention as it is a helpful tool in maintaining a stable level of mental functioning and caregiver mastery.

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

BACKGROUND: Depression 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/DESIGN: Here, 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. DISCUSSION: If 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 REGISTRATION: The Dutch Cochrane Center, NTR2772.

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 Parkinson's 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.

BACKGROUND: The 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/DESIGN: This 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. DISCUSSION: Because 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 REGISTRATION: ClinicalTrials.gov identifier: NCT02054845. Date of registration: 30 January 2014.

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.

A computer-based screening method for distress in patients with multiple sclerosis: a feasibility study.

BACKGROUND: In multiple sclerosis (MS) patients, symptoms of anxiety, depression, pain, and cognitive impairment are highly prevalent and contribute to lower wellbeing. As these physical and psychological symptoms of distress often stay unnoticed, regular screening could offer possibilities to identify and refer impaired patients to appropriate care. OBJECTIVE: The aim of our study was to pilot a new computer-based method in 43 MS patients to efficiently screen for a variety of psychological and physical symptoms of distress. METHODS: Data on feasibility and psychological and physical distress (anxiety, depression, fatigue, physical disability, cognitive functioning) were collected via a touch screen computer. Referral to psychosocial care and rehabilitation was retrospectively checked. RESULTS: The results demonstrated that most patients (35/40, 88%) considered the screening meaningful and the system easily usable (37/40, 93%). Average completion time of the screening was below 8 minutes. Many patients (35/40, 88%) had elevated distress levels, of whom the majority was referred. CONCLUSIONS: These findings imply that computer-based screening for MS-related distress incorporated in clinical care is feasible and aids to identify psychological or physical needs. A randomized controlled trial with follow-up should address whether this screening method could be more effective than routine care, and whether it can improve costs and efficiency of care.

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.