scholarly journals MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Robin J. Murphy ◽  
Rachael L. Sumner ◽  
William Evans ◽  
David Menkes ◽  
Ingo Lambrecht ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Grey Literature ◽  
Treatment Protocol ◽  
Resting State Fmri ◽  
Trial Registration ◽  
Online Forums ◽  
Obsessive Compulsive ◽  
Therapeutic Implications ◽  
Activity Tracker ◽  
Obsessive Compulsive Disorders

Abstract Background Regular ingestion of sub-hallucinogenic doses of psychedelics, referred to as “microdosing”, has gained increasing popularity and attention in the press and in online forums, with reported benefits across multiple cognitive and emotional domains. Rigorously controlled studies to date, however, have been limited in scope and have failed to produce results comparable to those reported in the grey literature. Methods Eighty healthy male participants will receive 14 doses of placebo or 10 μg lysergic acid diethylamide orally every 3rd day over a 6-week treatment protocol. A battery of personality, creativity, mood, cognition, and EEG plasticity measures, as well as resting-state fMRI imaging, will be administered at baseline and at the end of the protocol. Creativity, mood, and plasticity measures will additionally be assessed in the acute phase of the first dose. Daily functioning will be monitored with questionnaires and a wearable sleep and activity tracker. Discussion This study will rigorously examine the claims presented in the microdosing grey literature by pairing a comparable dosing protocol with objective measures. Potential therapeutic implications include future clinical trials to investigate microdosed psychedelics as a standalone treatment or as an augmentation of psychotherapy in the treatment of depression, addiction, eating disorders, obsessive-compulsive disorders, and palliative care. Trial registration ACTRN12621000436875. Registered on 19 February 2021

scholarly journals In a double-blind, randomized and placebo-controlled trial, adjuvant memantine improved symptoms in inpatients suffering from refractory obsessive-compulsive disorders (OCD)

2013 ◽  
Vol 228 (4) ◽  
pp. 633-640 ◽  
Author(s):  
Mohammad Haghighi ◽  
Leila Jahangard ◽  
Hamid Mohammad-Beigi ◽  
Hafez Bajoghli ◽  
Hassan Hafezian ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Obsessive Compulsive Disorders ◽  
Compulsive Disorders

scholarly journals Development of an optimised physiotherapist-led treatment protocol for lateral elbow tendinopathy: a consensus study using an online nominal group technique

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053841
Author(s):  
Marcus Bateman ◽  
Benjamin Saunders ◽  
Chris Littlewood ◽  
Jonathan C Hill
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Treatment Options ◽  
Treatment Protocol ◽  
Nominal Group Technique ◽  
Trial Registration ◽  
Nominal Group ◽  
Lateral Elbow ◽  
Randomised Controlled ◽  
Lateral Elbow Tendinopathy

ObjectivesThere are a wide range of physiotherapy treatment options for people with lateral elbow tendinopathy (LET); however, previous studies have reported inconsistent approaches to treatment and a lack of evidence demonstrating clinical effectiveness. This study aimed to combine the best available research evidence with stakeholder perspectives to develop key components of an optimised physiotherapist-led treatment protocol for testing in a future randomised controlled trial (RCT).DesignOnline consensus groups using nominal group technique (NGT), a systematic approach to building consensus using structured multistage meetings.SettingUK National Health Service (NHS).Participants10 physiotherapists with special interest in LET, 2 physiotherapy service managers and 3 patients who had experienced LET.InterventionsTwo consensus groups were conducted; the first meeting focused on agreeing the types of interventions to be included in the optimised treatment protocol; the second meeting focused on specific details of intervention delivery. Participants were sent an evidence summary of available treatments for LET prior to the first meeting. All treatment options were discussed before anonymous voting and ranking of priority. Consensus for inclusion of each treatment option was set at ≥70% based on OMERACT guidelines. Options with 30%–69% agreement were discussed again, and a second vote was held, allowing for a change of opinion.ResultsThe optimised physiotherapist-led treatment package included: advice and education, exercise therapy and orthotics. Specific components for each of these interventions were also agreed such as: condition-specific advice, health-promotion advice, exercise types, exercise into ‘acceptable’ levels of pain, exercise dosage and type of orthoses. Other treatment options including electrotherapy, acupuncture and manual therapy were excluded.ConclusionAn optimised physiotherapist-led treatment protocol for people with LET was successfully developed using an online NGT consensus approach. This intervention is now ready for testing in a future pilot/feasibility RCT to contribute much needed evidence about the treatment of LET.Trial registration numberThis is the pre-cursor to the OPTimisE Pilot and Feasibility Randomised Controlled Trial. Registration: https://www.isrctn.com/ISRCTN64444585

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

Dysregulation of DNA methylation during development as a potential mechanisms contributing to obsessive compulsive disorders and autism

2019 ◽  
Author(s):  
German I. Todorov ◽  
Karthikeyan Mayilvahanan ◽  
David Ashurov ◽  
Catarina Cunha
Keyword(s):  
Mouse Model ◽  
Autism Spectrum ◽  
Obsessive Compulsive ◽  
Cancer Treatments ◽  
Knock Out ◽  
Treatment Priority ◽  
Underlying Mechanisms ◽  
Knock Out Mice ◽  
Obsessive Compulsive Disorders ◽  
Compulsive Disorders

Autism Spectrum Disorder (ASD) is a pervasive developmental disorder, that is raising at a concerning rate. However, underlying mechanisms are still to be discovered. Obsessions and compulsions are the most debilitating aspect of these disorders (OCD), and they are the treatment priority for patients. SAPAP3 knock out mice present a reliable mouse model for repetitive compulsive behavior and are mechanistically closely related to the ASD mouse model Shank3 on a molecular level and AMPA receptor net effect. The phenotype of SAPAP3 knock out mice is obsessive grooming that leads to self-inflicted lesions by 4 months of age. Recent studies have accumulated evidence, that epigenetic mechanisms are important effectors in psychiatric conditions such as ASD and OCD. Methylation is the most studied mechanism, that recently lead to drug developments for more precise cancer treatments. We injected SAPAP3 mice with an epigenetic demethylation drug RG108 during pregnancy and delayed the onset of the phenotype in the offspring by 4 months. This result gives us clues about possible mechanism involved in OCD and ASD. Additionally, it shows that modulation of methylation mechanisms during development might be explored as a preventative treatment in the cases of high inherited risk of certain mental health conditions.

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