Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder:Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial

Abstract Background Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the \u201cThe Unified Protocol for Transdiagnostic Treatment of Emotional Disorders\u201d (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. Methods/design The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6\ua0months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. Discussion The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect. Trial registration Clinicaltrials.gov NCT02954731 . Registered 25 October 201

Gold micro-particles for knee osteoarthritis

BACKGROUND: This exploratory study investigates if intra‐articular injected gold microparticles in knee osteoarthritis (KOA) reduce immunomodulatory‐based pain via proteomic changes in the synovial fluid (SF) and serum. METHODS: Thirty patients with moderate KOA were included. Intraarticular injections with 20 mg gold microparticles (72.000 particles, 20–40 µm in diameter) using the patient's synovial fluid (SF) as carrier were performed. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscores for pain, stiffness, and function were assessed at inclusion, 8 weeks and 2 years The PainDetect questionnaire, pain pressure threshold (PPT), temporal summation (TS), and conditioned pain modulation (CPM), and pain diary were assessed at inclusion and 8 weeks. Proteome analysis was performed on SF and blood samples before and after 8 weeks of treatment. RESULTS: A decrease in WOMAC scores (pain (p = 0.0001), stiffness (p = 0.0088), activity (p = 0.0001)), PainDetect (p = 0.0002) and increase in PPT (p = 0.001) and CPM (p = 0.021) and a decrease in TS (p = 0.03) were found after 8 weeks compared to inclusion assessments. At 2 years follow‐up compared to baseline there was a decrease in WOMAC scores (pain (p = 0.0001), stiffness (p = 0.007), activity (p = 0.0001)) and PainDetect (p = 0.0001). In SF, 28 different proteins were downregulated and 11 upregulated (p < 0.05) mainly associated immune response. Similarly, 31 proteins were downregulated and 1 upregulated in serum (p < 0.05) reflecting key immune response and anatomical structure development processes. No adverse effects related to the treatment were recorded. CONCLUSIONS: Gold microparticles injected intra‐articular in KOA joints may provide pain relief and an inflammatory modulatory effect based on proteome changes found in SF and serum. A randomized, controlled, double‐blind study is needed to infer a conclusion. SIGNIFICANCE: This study indicates that intra‐articular gold may provide advantages in clinical practice for managing knee osteoarthritic pain. The use of intraarticular gold can add new knowledge to the treatment of inflammation and pain