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#rct

6 posts5 participants1 post today
Public
Jan R. Boehnke

Trigg et al discussed conceptualisations of meaningful between-group differences:
rdcu.be/ehHdD

A comment by Kevin Weinfurt advances the discussion w 4 points
rdcu.be/ehHfS

#RCT #Estimand #HRQL

From the abstract:

(1) rather than “between-group difference,” specify the level at which you wish to infer a treatment effect: population or individual;

(2) points of reference may be different for interpreting individual- and population-level treatment effect estimates;
...

rdcu.beConceptualizing meaningful between-group difference in change over time: a demonstration of possible viewpoints
Public
Jan R. Boehnke

Mirjam Stieger (Lucerne Uni) and I are invited to present
"Contemporary #Evaluation of Interventions: Mobile, Digital, and Pragmatic"
at @unibern
bbs.unibe.ch/training/summer_c

This is the annual Summer Course of the Doctoral Program Brain and Behavioral Sciences, and comprises a mixture of keynotes, masterclasses, hidden curriculum etc.

I am very much looking forward to it, and also very honoured to be invited once again to Bern to train #ECRs!

Doctoral Program Brain and Behavioral SciencesSummer Course 2025
#RCT#EvaluationResearch#ResearchDesign
Public
Susi Arnott

Love this work! #Placebos more effective when patients aware. Would #rct double-blind protocols also have an impact? #MedSci
ebm.bmj.com/content/early/2025

BMJ Evidence-Based Medicine · Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trialObjective To investigate the efficacy and safety of open-label placebos (OLP) in premenstrual syndrome (PMS). Design Randomised controlled trial. Setting Switzerland, 2018–2020. Participants 150 women (18–45 years of age) with PMS or premenstrual dysphoric disorder. Intervention Random assignment (1:1:1) to treatment as usual (TAU), OLP without treatment rationale (OLP–), or OLP with treatment rationale (OLP+). OLP consisted of two placebo pills per day for 6 weeks. Main outcome measures Primary outcomes were PMS symptom intensity and interference between groups across three menstrual cycles (MC1–MC3); adverse events (ie, safety) were measured at weeks 3 and 6 after the start of the intervention. Secondary outcomes were psychological and somatic subscales of PMS symptom intensity, and adherence. Results From 2 August 2018 to 3 December 2020, 150 women were randomly allocated to TAU (n=50), OLP– (n=50), and OLP+ (n=50), of whom 145 (96.7%) completed trial participation. Groups differed in symptom intensity (F(4)=4.419, p=0.002, r2=0.16) and interference (F(4)=3.159, p=0.014, r2=0.13) across three MCs. Mean symptom intensity at MC3 was lower for OLP+ compared to TAU (b=–9.97, SE=2.85, t(412)=3.50, p<0.001, d=0.90) and to OLP– (b=–6.10, SE=2.89, t(411)=2.11, p=0.036, d=0.55), but OLP– and TAU did not differ (b=–3.87, SE=2.87, t(411)=1.35, p=0.177, d=0.35). Mean interference at MC3 was lower for OLP+ compared to TAU (b=–1.23, SE=0.54, t(443)=2.30, p=0.022, d=0.55) and to OLP– (b=–1.10, SE=0.54, t(442)=2.02, p=0.044, d=0.48), but OLP– and TAU did not differ (b=–0.14, SE=0.54, t(442)=0.26, p=0.799, d=0.06). Four non-serious adverse events were reported in OLP– (n=1) and OLP+ (n=3). Improvement in psychological and somatic symptom intensity was comparable to primary outcomes. Adherence to the OLP intervention was high (93.18±18.95%), with no difference between groups. Conclusions The results of our clinical trial indicate that OLP provided with a treatment rationale is an effective, safe, and acceptable treatment for PMS. Trial registration ClinicalTrials.gov [NCT03547661][1] (submitted 2 May 2018). Data are available in a public, open access repository. Meta-data is openly accessible on the data repository Harvard Dataverse. Upon reasonable request, relevant anonymised participant-level data will be made available. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03547661&atom=%2Febmed%2Fearly%2F2025%2F03%2F05%2Fbmjebm-2024-112875.atom
Public
Jan R. Boehnke

56th International Meeting of the Society for Psychotherapy Research in Krakow, Poland, 25-28th June.

Conference theme:
"Psychotherapy Research-Practice Integration: Who Are the Voices We Need to Hear?"

Continuing training events around #RCT methods started with the SPR #Dundee Methods Workshop (2021), I'll offer a primer for planning randomised studies of psychotherapeutic interventions.

Other #conference workshops & registration here:
psychotherapyresearch.org/page

Screenshots from the conference registration page, at the top noting the conference topic and dates; at the bottom presenting an abstract for a workshop. Jan Boehnke A primer for planning randomised studies of psychotherapeutic interventions Studies involving randomisation are an integral part of strategies for the evaluation of (causal) effects of therapeutic strategies and interventions. This workshop will present the key elements and practical steps for planning, developing, conducting, and reporting randomised studies of psychological interventions. The core logic and statistical arguments for an experimental study of a psychological intervention will be briefly revisited to clarify when an experimental study (and which type of such a study) is indicated. The main part of the workshop will focus on how to plan, design, and report such a study, including formal requirements to conduct a high quality study (e.g., trial registrations, ethical requirements). We will discuss the use of international guidelines as well as how and when to prepare protocols, statistical analysis plans, and/or registered reports. The workshop is built around the experience from multiple published trials by the presenter and is planned for Q&A phases to tailor the content to the audience. The aim of the workshop is to provide participants with the tools to assess published randomised studies of psycho-social interventions and the steps and resources needed to develop their own study.
#PsychotherapyResearch#Hybrid
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