Physical and sexual abuse during childhood can have long lasting consequences such as posttraumatic stress disorder (PTSD). Prolonged Exposure (PE) is an established and effective guideline... Show morePhysical and sexual abuse during childhood can have long lasting consequences such as posttraumatic stress disorder (PTSD). Prolonged Exposure (PE) is an established and effective guideline treatment for PTSD. Nevertheless, a considerable number of patients drop out from treatment or do not (completely) recover from PTSD during PE. It has been suggested that patients with PTSD resulting from childhood abuse are specifically at risk for suboptimal treatment outcomes. We carried out a randomized controlled trial with 149 patients with childhood abuse-related PTSD comparing PE with two innovations: intensified PE (iPE) and skills training in affective and interpersonal regulation followed by PE (STAIR+PE). We found that all treatments were safe and resulted in large improvements in PTSD symptoms. iPE and STAIR+PE did not improve treatment outcomes of PE, although iPE led to faster symptom improvements. Not all patients benefitted from the allocated treatment, but we found no contra-indications for the treatments. We found that a combination of patient characteristics was predictive of a larger effect size of PTSD symptom improvement in PE and iPE or STAIR+PE. We conclude that the three forms of exposure therapy were effective treatments for patients with childhood abuse-related PTSD. Show less
Manai, M.; Middendorp, H. van; Veldhuijzen, D.S.; Pol, J.A. van der; Huizinga, T.W.J.; Evers, A.W.M. 2020
Background In pharmacological conditioning associations are formed between the effects of medication and contextual factors related to the medication. Pharmacological conditioning with placebo... Show moreBackground In pharmacological conditioning associations are formed between the effects of medication and contextual factors related to the medication. Pharmacological conditioning with placebo medication can result in comparable treatment effects and reduced side effects compared to regular treatment in various clinical populations, and may be applied to achieve enhanced drug effects. In the current study protocol, pharmacological conditioning is applied to achieve enhanced treatment effects in patients with recent-onset rheumatoid arthritis (RA). The results from this study broaden the knowledge on the potential of pharmacological conditioning and provide a potential innovative treatment option to optimize long-term pharmacological treatment effectiveness for patients with inflammatory conditions, such as recent-onset RA. Methods A multicenter, randomized controlled clinical trial is conducted in patients with recent-onset RA. Participants start on standardized pharmacological treatment for 16 weeks, which consists of methotrexate (MTX) 15 mg/week and a tapered schedule of prednisone 60 mg or 30 mg. After 4 months, participants in clinical remission (based on the rheumatologist's opinion and a targeted score below 1.6 on a 44-joint disease activity score (DAS44)) are randomized to 1 of 2 groups: (1) the control group (C), which continues with a standardized treatment schedule of MTX 15 mg/week or (2) the pharmacological conditioning group (PC), which receives an MTX treatment schedule in alternating high and low dosages. In the case of persistent clinical remission after 8 months, treatment is tapered and discontinued linearly in the C group and variably in the PC group. Both groups receive the same cumulative amount of MTX during each period. Logistic regression analysis is used to compare the proportion of participants with drug-free clinical remission after 12 months between the C group and the PC group. Secondary outcome measures include clinical functioning, laboratory assessments, and self-reported measures after each 4-month period up to 18 months after study start. Discussion The results from this study broaden the knowledge on the potential of pharmacological conditioning and provide a potential innovative treatment option to optimize long-term pharmacological treatment effectiveness in patients with inflammatory conditions, such as recent-onset RA. Show less
Passel, B. van; Danner, U.; Dingemans, A.; Furth, E. van; Sternheim, L.; Elburg, A. van; ... ; Cath, D. 2016
