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
Source: All – Medical Journals
Internet-Based Cognitive Behavioral Therapy in Stepped Care for Chronic Fatigue Syndrome: Randomized Noninferiority Trial