Clinical effectiveness, cost-effectiveness and process evaluation of group schema therapy for eating disorders: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Eating disorders (EDs), such as (atypical) Anorexia (AN) and Bulimia Nervosa (BN), are difficult to treat, causing socioeconomic impediments. Although enhanced cognitive behavioral therapy (CBT-E) is widely considered clinically effective, it may not be the most beneficial treatment for (atypical) AN and BN patients who do not show a rapid response after the first 4 weeks (8 sessions) of a CBT-E treatment. Alternatively, group schema therapy (GST) may be a valuable treatment for this ED population. Even though GST for EDs has yielded promising preliminary findings, the current body of evidence requires expansion. On top of that, data on cost-effectiveness is lacking. In light of these gaps, we aim to describe a protocol to examine whether GST is more (1) clinically effective and (2) cost-effective than CBT-E for (atypical) AN and BN patients, who do not show a rapid response after the first 4 weeks of treatment. Additionally, we will conduct (3) process evaluations for both treatments. METHODS: Using a multicenter RCT design, 232 Dutch (atypical) AN and BN patients with a CBT-E referral will be recruited from five treatment centers. Clinical effectiveness and cost-effectiveness will be measured before treatment, directly after treatment, at 6 and at 12 months follow-up. In order to rate process evaluation, patient experiences and the degree to which treatments are implemented according to protocol will be measured. In order to assess the quality of life and the achievement of personalized goals, interviews will be conducted at the end of treatment. Data will be analyzed, using a regression-based approach to mixed modelling, multivariate sensitivity analyses and coding trees for qualitative data. We hypothesize GST to be superior to CBT-E in terms of clinical effectiveness and cost-effectiveness for patients who do not show a rapid response to the first 4 weeks of a CBT-E treatment. DISCUSSION: To our knowledge, this is the first study protocol describing a multicenter RCT to explore the three aforementioned objectives. Related risks in performing the study protocol have been outlined. The expected findings may serve as a guide for healthcare stakeholders to optimize ED care trajectories. TRIAL REGISTRATION: clinicaltrials.gov (NCT05812950).

Acting and Feeling Like a Vulnerable Child, an Internalized "Bad" Parent, or a Healthy Person: The Assessment of Schema Modes in Non-Clinical Adolescents.

Schema modes are strong, predominant, momentary (state-like) emotional and cognitive states, and maladaptive coping responses that occur when underlying personality schemas are activated by emotional events. The current study employed the Schema Mode Inventory for Adolescents (SMI-A) to assess such schema modes in a sample of non-clinical adolescents (n = 530). Confirmatory factor analysis revealed that the hypothesized model of the SMI-A with 14 separate schema modes provided a good fit for the data. Reliability coefficients for the various schema modes were all in the adequate to good range. Finally, the validity of the SMI-A was supported by significant and meaningful relations between schema modes on the one hand and early maladaptive schema domains, symptoms of psychopathology, and quality of life on the other. Taken together, the psychometric properties of the SMI-A are promising, and the SMI-A can be considered a viable instrument to assess schema modes in adolescents.

An electronic diary assessment of the effects of distraction and attentional focusing on pain intensity in chronic low back pain patients.

OBJECTIVE: The present study examined the effects of a manipulation of attention to pain (i.e. attentional focusing vs. distraction) on pain intensity in daily life of patients with chronic low back pain. It was hypothesized that attentional focusing would lead to decreased pain intensity in high pain fearful individuals, whereas distraction from pain would be associated with decreased pain intensity in low pain fearful individuals. DESIGN: An experience sampling methodology was used to examine the effects of a manipulation of attention to pain on pain intensity in daily life of pain patients. METHODS: A total number of 38 patients with chronic low back pain participated in this study and carried a palmtop computer for 2 weeks. During this period, patients were 'beeped' 8 times a day to complete diary questions. On certain days, instructions to either attend to or distract from pain were given. RESULTS: Multi-level analyses showed that attentional focusing was not associated with decreased pain intensity in high pain fearful individuals and that distraction did not lead to decreased pain intensity in low pain fearful individuals. The manipulations in isolation neither influenced pain intensity. The manipulation check was generally weak. CONCLUSION: A manipulation of attention to pain in daily life of patients with chronic low back pain proved difficult to accomplish. As the manipulation check was generally unsuccessful, no clear inferences about the underlying theory can be made. Future research within the field of pain treatments (e.g. in vivo exposure) might benefit greatly from electronic diary assessments studies.

Electronic diary assessment of pain-related fear, attention to pain, and pain intensity in chronic low back pain patients.

The present study investigated the relationships between pain-related fear, attention to pain, and pain intensity in daily life in patients with chronic low back pain. An experience sampling methodology was used in which electronic diary data were collected by means of palmtop computers from 40 chronic low back pain patients who were followed for one week. Attention to pain was hypothesized to mediate the relation between pain-related fear and pain intensity. Further, pain-related fear as a trait characteristic was expected to moderate the relation between attention to pain and pain intensity. Multi-level analysis was used for all analyses. Although the tested mediation models yielded statistically significant mediation effects, the sizes of these effects were relatively small and clinically irrelevant. Instead, results suggested that pain-related fear and attention to pain independently predicted pain intensity. No evidence for moderation of the relation between attention to pain and pain intensity by pain-related fear as a trait characteristic was found. Implications of the results from this study are discussed and suggestions for future research are provided.