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Clinical competency

Neutral, unbiased facilitation

The facilitator must minimize bias in how assessments are administered and in how participant responses are handled. This is important because the trial is open-label and relies heavily on patient-reported outcomes.

Primary clinical guidelineModern clinical

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Guidelines

3

Courses

0

Providers

0

Protocols

2

Classification

Protocol families

Source quality

Protocol paperSOP / guidebookTrial supplement

Also known as

Avoid conflicts of interest and biasObjective, neutral interviewing

Across the manuals

The manuals converge on the need for neutrality and reduced bias in assessment contexts. Across the extracts, the common thread is that facilitators and therapists are expected to avoid influencing participant responses, to keep assessments objective, and to preserve the reliability of data, especially where self-report or structured interviews are central. They also share an emphasis on consistency in how assessments are delivered and recorded, with attention to accurate documentation and a stable assessment environment. The sources differ in where they place the main risk of bias. The ketamine trial extract focuses on open-label assessment procedures, including avoiding influence on questionnaire answers, keeping patient-rated and clinician-rated assessments independent, using a neutral self-report setting, and keeping visits consistent. The MAPP2 synopsis is more specific about interview technique, recommending scripted, verbatim administration, a neutral stance in CAPS-5 and related interviews, and avoiding excessive clinical rapport during screening and primary outcome assessments. The MDMA manual differs again by framing bias mainly as a conflict-of-interest and dual-relationship issue, including pre-existing relationships, personal relationships with therapy providers, reassignment when objectivity is impaired, and sponsor notification when conflicts arise.

Synthesised from the linked source documents; refreshed as the library updates.

Linked sources

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Linked guidelines (3)

  • A Manual for Adherence Ratings of MDMA-Assisted Therapy for Treatment of Posttraumatic Stress Disorder

    MDMAEvidence score: 90

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