Adverse events in psychotherapy randomized controlled trials: A systematic review

Area of Science:

• Psychology
• Psychiatry
• Clinical Trials

Background:

• Evidence for psychotherapy benefits is extensive, but data on potential harm remains limited.
• Adverse events (AEs) in psychotherapy require systematic investigation to ensure patient safety.

Purpose of the Study:

• To systematically summarize randomized controlled trials (RCTs) on psychotherapy.
• To compile evidence-based data on the frequency and characteristics of adverse events (AEs) in psychotherapy.

Main Methods:

• Systematic review of result publications based on a review of harm consideration in psychotherapy study protocols.
• Inclusion of 85 RCTs with 126 psychotherapy and 61 control conditions, involving 14,420 participants with common mental disorders.

Main Results:

• Explicit reporting of harmful events, such as AEs and symptom deterioration, occurred in 60% of the studies.
• AE conceptualization, recording, and reporting methods were heterogeneous across studies, limiting comparability.
• AEs were reported to affect more than 10% of participants, with serious AEs affecting more than 4% in psychotherapy RCTs.

Conclusions:

• Substantial differences in AE recording approaches limit the comparability of study results.
• Consistent harm monitoring and reporting in psychotherapy RCTs are essential for a balanced risk/benefit evaluation.