Towards personalized assessment of fatigue perpetuating factors in patients with chronic fatigue syndrome using ecological momentary assessment: A pilot study.

OBJECTIVE: This study aimed to explore the associations between cognitions, behaviours and affects and fatigue in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), and their relation to reduction of fatigue after cognitive behaviour therapy (CBT). METHODS: In CFS/ME patients, 22 behaviours, cognitions and affects, potentially perpetuating fatigue were registered 5 times a day using ecological momentary assessment (EMA) and an actigraphy. Simultaneous Components Analysis (SCA) was used to identify components of perpetuation, that were tested for their associations with fatigue in multilevel vector autoregressive (VAR) modelling. Fatigue severity was measured pre- and posttreatment with the Checklist Individual Strength. The relationship between perpetuation (the strength and direction of the possible associations between fatigue and the components) and therapy outcome was investigated. RESULTS: 58 patients met inclusion criteria (m age = 36.5; 65.5% female) and data of 50 patients were analysed in the multilevel analysis. Two perpetuating components were found: "psychological discomfort" and "activity". For the total group, both perpetuating components did not predict fatigue on a following time-point. For individual patients the strength and direction of the associations varied. None of the associations between perpetuating components and fatigue significantly predicted treatment outcome. CONCLUSION: Results suggest that there is heterogeneity in perpetuation of fatigue in CFS/ME. Investigating fatigue and perpetuators on an individual rather than group level could lead to new insights.

Short fatigue questionnaire: Screening for severe fatigue.

OBJECTIVE: To determine psychometric properties, a cut-off score for severe fatigue and normative data for the 4-item Short Fatigue Questionnaire (SFQ) derived from the multi-dimensional fatigue questionnaire Checklist Individual Strength (CIS). METHODS: Data of previous studies investigating the prevalence of fatigue in ten chronic conditions (n = 2985) and the general population (n = 2288) was used to determine the internal consistency (Cronbach's alpha) of the SFQ, its relation with other fatigue measures (EORTC QLQ-30 fatigue subscale and digital fatigue diary), a cut-off score for severe fatigue (ROC analysis) and to examine whether the four SFQ items truly measure the same construct. Norms were calculated for ten patient groups and the Dutch general population. RESULTS: Cronbach's alpha of the SFQ were excellent in almost all groups. Pearson's correlations between the SFQ and the EORTC-QLQ-C30 fatigue subscale and a fatigue diary were respectively 0.76 and 0.68. ROC analysis showed an area under the curve of 0.982 (95% CI: 0.979-0.985) and cut-off score of 18 was suggested which showed a good sensitivity (0.984) and specificity (0.826) as well as excellent values for the positive and negative prediction values within all groups using the CIS as golden standard. Factor analysis showed a one factor solution (Eigenvalue: 3.095) with factor loadings of all items on the factor being greater than 0.87. CONCLUSION: The SFQ is an easy to use, reliable and valid instrument to screen for severe fatigue in clinical routine and research.

Implementing guided ICBT for chronic pain and fatigue: A qualitative evaluation among therapists and managers.

INTRODUCTION: Internet-based cognitive behavioural therapy (ICBT) for chronic pain and chronic fatigue syndrome (CFS) has a high potential to increase the number of patients who can receive an evidence based treatment aimed to reduce symptoms and/or disability and to lower burden on (mental) health care. However, implementing a new behaviour-change intervention, and especially an online intervention, has shown to be a challenge. This study aimed to identify factors influencing the implementation process of ICBT for chronic pain and CFS in mental health care. METHODS: A qualitative study using semi-structured interviews with therapists and managers from twelve mental health care clinics was conducted. Questions and analysis were guided by the Consolidated Framework for Implementation Research (CFIR), covering five domains: (1) the implemented intervention, (2) individual characteristics of the users, (3) the inner setting of implementation, (4) the outer setting, and (5) the implementation process. RESULTS: In all five domains important facilitators and barriers were found. Key themes were: (1) the quality of the content, its perceived effectiveness and usability, (2) the attitude, self-efficacy and ability to learn new skills among therapists, and motivation to start online treatment among patients, (3) internal communication within a team, existing workload, and top-down support from the management, (4) availability of reimbursement options and marketing strategies, and (5) involvement of all key stakeholders, steering towards independence of the implementation sites during the process and adequate training of therapists. CONCLUSIONS: This study provides insight in the challenge of implementing ICBT for chronic pain and CFS in daily clinical practice. Several lessons can be learned from the interviews with therapists and managers which can also be more broadly applied to (ICBT) implementation projects in general. Development of practical tools to support the implementation process would be a valuable next step to overcome certain challenges at forehand and to properly prepare for those expected to come along.

Internet-Based Cognitive Behavioral Therapy for Chronic Fatigue Syndrome Integrated in Routine Clinical Care: Implementation Study.

BACKGROUND: In a clinical trial, internet-based cognitive behavioral therapy (I-CBT) embedded in stepped care was established as noninferior to face-to-face cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS). However, treatment effects observed in clinical trials may not necessarily be retained after implementation. OBJECTIVE: This study aimed to investigate whether stepped care for CFS starting with I-CBT, followed by face-to-face CBT, if needed, was also effective in routine clinical care. Another objective was to explore the role of therapists' attitudes toward electronic health (eHealth) and manualized treatment on treatment outcome. METHODS: I-CBT was implemented in five mental health care centers (MHCs) with nine treatment sites throughout the Netherlands. All patients with CFS were offered I-CBT, followed by face-to-face CBT if still severely fatigued or disabled after I-CBT. Outcomes were the Checklist Individual Strength, physical and social functioning (Short-Form 36), and limitations in daily functioning according to the Work and Social Adjustment Scale. The change scores (pre to post stepped care) were compared with a benchmark: stepped care from a randomized controlled trial (RCT) testing this treatment format. We calculated correlations of therapists' attitudes toward manualized treatment and eHealth with reduction of fatigue severity. RESULTS: Overall, 100 CFS patients were referred to the centers. Of them, 79 started with I-CBT, 20 commenced directly with face-to-face CBT, and one did not start at all. After I-CBT, 48 patients met step-up criteria; of them, 11 stepped up to face-to-face CBT. Increase in physical functioning (score of 13.4), social functioning (20.4), and reduction of limitations (10.3) after stepped care delivered in routine clinical care fell within the benchmarks of the RCT (95% CIs: 12.8-17.6; 25.2-7.8; and 7.4-9.8, respectively). Reduction of fatigue severity in the MHCs was smaller (12.6) than in the RCT (95% CI 13.2-16.5). After I-CBT only, reduction of fatigue severity (13.2) fell within the benchmark of I-CBT alone (95% CI 11.1-14.2). Twenty therapists treated between one and 18 patients. Therapists were divided into two groups: one with the largest median reduction of fatigue and one with the smallest. Patients treated by the first group had a significantly larger reduction of fatigue severity (15.7 vs 9.0; t=2.42; P=.02). There were no (statistically significant) correlations between therapists' attitudes and reduction in fatigue. CONCLUSIONS: This study is one of the first to evaluate stepped care with I-CBT as a first step in routine clinical care. Although fatigue severity and disabilities were reduced, reduction of fatigue severity appeared smaller than in the clinical trial. Further development of the treatment should aim at avoiding dropout and encouraging stepping up after I-CBT with limited results. Median reduction of fatigue severity varied largely between therapists. Further research will help understand the role of therapists' attitudes in treatment outcome.

Internet-Based Cognitive Behavioral Therapy in Stepped Care for Chronic Fatigue Syndrome: Randomized Noninferiority Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (I-CBT) leads to a reduction of fatigue severity and disability in adults with chronic fatigue syndrome (CFS). However, not all patients profit and it remains unclear how I-CBT is best embedded in the care of CFS patients. OBJECTIVE: This study aimed to compare the efficacy of stepped care, using therapist-assisted I-CBT, followed by face-to-face (f2f) cognitive behavioral therapy (CBT) when needed, with f2f CBT (treatment as usual [TAU]) on fatigue severity. The secondary aim was to investigate treatment efficiency. METHODS: A total of 363 CFS patients were randomized to 1 of the 3 treatment arms (n=121). There were 2 stepped care conditions that differed in the therapists' feedback during I-CBT: prescheduled or on-demand. When still severely fatigued or disabled after I-CBT, the patients were offered f2f CBT. Noninferiority of both stepped care conditions to TAU was tested using analysis of covariance. The primary outcome was fatigue severity (Checklist Individual Strength). Disabilities (Sickness Impact Profile -8), physical functioning (Medical Outcomes Survey Short Form-36), psychological distress (Symptom Checklist-90), and proportion of patients with clinically significant improvement in fatigue were the secondary outcomes. The amount of invested therapist time was compared between stepped care and TAU. Exploratory comparisons were made between the stepped care conditions of invested therapist time and proportion of patients who continued with f2f CBT. RESULTS: Noninferiority was indicated, as the upper boundary of the one-sided 98.75% CI of the difference in the change in fatigue severity between both forms of stepped care and TAU were below the noninferiority margin of 5.2 (4.25 and 3.81, respectively). The between-group differences on the secondary outcomes were also not significant (P=.11 to P=.79). Both stepped care formats required less therapist time than TAU (median 8 hours, 9 minutes and 7 hours, 25 minutes in stepped care vs 12 hours in TAU; P<.001). The difference in therapist time between both stepped care formats was not significant. Approximately half of the patients meeting step-up criteria for f2f CBT after I-CBT did not continue. CONCLUSIONS: Stepped care, including I-CBT followed by f2f CBT when indicated, is noninferior to TAU of f2f CBT and requires less therapist time. I-CBT for CFS can be used as a first step in stepped care. TRIAL REGISTRATION: Nederlands Trial Register NTR4809; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4809 (Archived by WebCite at http://www.webcitation.org/74SWkw1V5).

Testing the efficacy of web-based cognitive behavioural therapy for adult patients with chronic fatigue syndrome (CBIT): study protocol for a randomized controlled trial.

BACKGROUND: Cognitive behavioural therapy (CBT) is an effective treatment for fatigue and disabilities in patients with chronic fatigue syndrome (CFS). However, treatment capacity is limited. Providing web-based CBT and tailoring the amount of contact with the therapist to the individual needs of the patient may increase the efficiency of the intervention. Web-based CBT for adolescents with CFS has proven to be effective in reducing fatigue and increasing school attendance. In the proposed study the efficacy of a web-based CBT intervention for adult patients with CFS will be explored. Two different formats of web-based CBT will be tested. In the first format named protocol driven feedback, patients report on their progress and receive feedback from a therapist according to a preset schedule. In the second format named support on demand, feedback and support of the therapist is only given when patients ask for it. The primary objective of the study is to determine the efficacy of a web-based CBT intervention on fatigue severity. METHOD/DESIGN: A randomized clinical trial will be conducted. Two-hundred-forty adults who have been diagnosed with CFS according to the US Centers for Disease Control and Prevention (CDC) consensus criteria will be recruited and randomized to one of three conditions: web-based CBT with protocol driven feedback, web-based CBT with support on demand, or wait list. Feedback will be delivered by therapists specialized in CBT for CFS. Each of the web-based CBT interventions will be compared to a wait list condition with respect to its effect on the primary outcome measure; fatigue severity. Secondary outcome measures are level of disability, physical functioning, psychological distress, and the proportion of patients with clinical significant improvement in fatigue severity. Outcomes will be assessed at baseline and six months post randomization. The web-based CBT formats will be compared with respect to the time therapists need to deliver the intervention. DISCUSSION: As far as we know this is the first randomized controlled trial (RCT) that evaluates the efficacy of a web-based CBT intervention for adult patients with CFS. TRIAL REGISTRATION: NTR4013.