PMID- 38090772
OWN - NLM
STAT- Publisher
LR  - 20231213
IS  - 1468-4381 (Electronic)
IS  - 1050-3307 (Linking)
DP  - 2023 Dec 13
TI  - Adverse events in psychotherapy randomized controlled trials: A systematic 
      review.
PG  - 1-16
LID - 10.1080/10503307.2023.2286992 [doi]
AB  - Objective: Although evidence for benefits of psychotherapy is substantial, less 
      is known about potential harm. Therefore, we systematically summarized randomized 
      controlled trials (RCTs) to compile evidence-based data on the frequency and 
      characteristics of adverse events (AEs) of psychotherapy. Method: This systematic 
      review of result publications is based on a review of harm consideration in 
      psychotherapy study protocols. Results: On the basis of 115 study protocols, 85 
      RCTs with 126 psychotherapy and 61 control conditions were eligible for 
      inclusion. The sample consisted of 14,420 participants with the most common 
      mental disorders. Harmful events, e.g., AEs, number of individuals with symptom 
      deterioration, were explicitly reported in 60% of the studies. Conceptualization, 
      recording, and reporting of AEs were heterogeneous. For most reported AEs, the 
      association to study treatment remained unclear. Conclusions: Because the AE 
      recording approaches of the individual studies differed substantially, results 
      could only be compared to a limited extent. Consistent with other findings, this 
      review demonstrates that AEs can be expected to affect more than one in ten 
      participants. Serious AEs occurred more than in one in 21 participants in 
      psychotherapy RCTs. To allow a balanced risk/benefit evaluation of psychotherapy, 
      systematic harm monitoring and reporting should become standard in psychotherapy 
      RCTs.
FAU - Klatte, Rahel
AU  - Klatte R
AD  - University Hospital Jena, Institute of Psychosocial Medicine, Psychotherapy and 
      Psychooncology, Jena, Germany.
FAU - Strauss, Bernhard
AU  - Strauss B
AUID- ORCID: 0000-0002-8555-2538
AD  - University Hospital Jena, Institute of Psychosocial Medicine, Psychotherapy and 
      Psychooncology, Jena, Germany.
FAU - Fluckiger, Christoph
AU  - Fluckiger C
AUID- ORCID: 0000-0003-3058-5815
AD  - University of Kassel, Department of Psychology, Kassel, Germany.
FAU - Rosendahl, Jenny
AU  - Rosendahl J
AUID- ORCID: 0000-0001-7535-7571
AD  - University Hospital Jena, Institute of Psychosocial Medicine, Psychotherapy and 
      Psychooncology, Jena, Germany.
LA  - eng
PT  - Journal Article
DEP - 20231213
PL  - England
TA  - Psychother Res
JT  - Psychotherapy research : journal of the Society for Psychotherapy Research
JID - 9110958
SB  - IM
OTO - NOTNLM
OT  - RCT
OT  - adverse events
OT  - harm
OT  - psychotherapy
OT  - systematic review
EDAT- 2023/12/13 18:42
MHDA- 2023/12/13 18:42
CRDT- 2023/12/13 13:17
PHST- 2023/12/13 18:42 [medline]
PHST- 2023/12/13 18:42 [pubmed]
PHST- 2023/12/13 13:17 [entrez]
AID - 10.1080/10503307.2023.2286992 [doi]
PST - aheadofprint
SO  - Psychother Res. 2023 Dec 13:1-16. doi: 10.1080/10503307.2023.2286992.