title: Does Internet-based guided-self-help for depression cause harm? An individual participant data meta-analysis on deterioration rates and its moderators in randomized controlled trials.
abstract: Almost nothing is known about the potential negative effects of Internet-based psychological treatments for depression. This study aims at investigating deterioration and its moderators within randomized trials on Internet-based guided self-help for adult depression, using an individual patient data meta-analyses (IPDMA) approach.
  
  
  
  Studies were identified through systematic searches (PubMed, PsycINFO, EMBASE, Cochrane Library). Deterioration in participants was defined as a significant symptom increase according to the reliable change index (i.e. 7.68 points in the CES-D; 7.63 points in the BDI). Two-step IPDMA procedures, with a random-effects model were used to pool data.
  
  
  
  A total of 18 studies (21 comparisons, 2079 participants) contributed data to the analysis. The risk for a reliable deterioration from baseline to post-treatment was significantly lower in the intervention v. control conditions (3.36 v. 7.60; relative risk 0.47, 95% confidence interval 0.29-0.75). Education moderated effects on deterioration, with patients with low education displaying a higher risk for deterioration than patients with higher education. Deterioration rates for patients with low education did not differ statistically significantly between intervention and control groups. The benefit-risk ratio for patients with low education indicated that 9.38 patients achieve a treatment response for each patient experiencing a symptom deterioration.
  
  
  
  Internet-based guided self-help is associated with a mean reduced risk for a symptom deterioration compared to controls. Treatment and symptom progress of patients with low education should be closely monitored, as some patients might face an increased risk for symptom deterioration. Future studies should examine predictors of deterioration in patients with low education.
authors.affiliation: Friedrich Alexander University Erlangen-Nuremberg,Erlangen,Germany.
authors.forename: D D
authors.initials: DD
authors.lastname: Ebert
authors.affiliation: The Brain and Mind Research Institute,University of Sydney,NSW,Australia.
authors.forename: L
authors.initials: L
authors.lastname: Donkin
authors.affiliation: Department of Behavioural Sciences and Learning,Linköping University,Linköping,Sweden.
authors.forename: G
authors.initials: G
authors.lastname: Andersson
authors.affiliation: Clinical Research Unit for Anxiety and Depression,School of Psychiatry,University of New South WalesatSt Vincent's Hospital,Darlinghurst,NSW,Australia.
authors.forename: G
authors.initials: G
authors.lastname: Andrews
authors.affiliation: Department of Clinical Psychology and Psychotherapy,University of Bern,Bern,Switzerland.
authors.forename: T
authors.initials: T
authors.lastname: Berger
authors.affiliation: Department of Psychology,Stockholm University,Sweden.
authors.forename: P
authors.initials: P
authors.lastname: Carlbring
authors.affiliation: Department of Psychology,Stockholm University,Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Rozenthal
authors.affiliation: Brain and Mind Centre,University of Sydney,Sydney,Australia.
authors.forename: I
authors.initials: I
authors.lastname: Choi
authors.affiliation: Psychologische Hochschule Berlin.
authors.forename: J A C
authors.initials: JA
authors.lastname: Laferton
authors.affiliation: Department of Behavioural Sciences and Learning,Linköping University,Linköping,Sweden.
authors.forename: R
authors.initials: R
authors.lastname: Johansson
authors.affiliation: Department of Clinical,Neuro and Developmental Psychology,VU University Amsterdam,the Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Kleiboer
authors.affiliation: Department of Clinical Psychology,University of Amsterdam,Amsterdam,The Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Lange
authors.affiliation: Leuphana University Lüneburg,Germany.
authors.forename: D
authors.initials: D
authors.lastname: Lehr
authors.affiliation: Leuphana University Lüneburg,Germany.
authors.forename: J A
authors.initials: JA
authors.lastname: Reins
authors.affiliation: Leuphana University Lüneburg,Germany.
authors.forename: B
authors.initials: B
authors.lastname: Funk
authors.affiliation: Clinical Research Unit for Anxiety and Depression,School of Psychiatry,University of New South WalesatSt Vincent's Hospital,Darlinghurst,NSW,Australia.
authors.forename: J
authors.initials: J
authors.lastname: Newby
authors.affiliation: Centre for Emotional Health,Macquarie University,Australia.
authors.forename: S
authors.initials: S
authors.lastname: Perini
authors.affiliation: Department of Clinical,Neuro and Developmental Psychology,VU University Amsterdam,the Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Riper
authors.affiliation: Department of Clinical,Neuro and Developmental Psychology,VU University Amsterdam,the Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Ruwaard
authors.affiliation: Oregon Research Institute,Eugene,Oregon,USA.
authors.forename: L
authors.initials: L
authors.lastname: Sheeber
authors.affiliation: Department of Medical Psychology,VU University Medical Center Amsterdam,The Netherlands.
authors.forename: F J
authors.initials: FJ
authors.lastname: Snoek
authors.affiliation: eCentreClinic and MindSpot Clinic,Department of Psychology,Macquarie University,Australia.
authors.forename: N
authors.initials: N
authors.lastname: Titov
authors.affiliation: Department of Clinical,Neuro and Developmental Psychology,VU University Amsterdam,the Netherlands.
authors.forename: B
authors.initials: B
authors.lastname: Ünlü Ince
authors.affiliation: Department of Medical Psychology,VU University Medical Center Amsterdam,The Netherlands.
authors.forename: K
authors.initials: K
authors.lastname: van Bastelaar
authors.affiliation: Department of Behavioural Sciences and Learning,Linköping University,Linköping,Sweden.
authors.forename: K
authors.initials: K
authors.lastname: Vernmark
authors.affiliation: Department of Clinical,Neuro and Developmental Psychology,VU University Amsterdam,the Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: van Straten
authors.affiliation: Department of Clinical,Neuro and Developmental Psychology,VU University Amsterdam,the Netherlands.
authors.forename: L
authors.initials: L
authors.lastname: Warmerdam
authors.affiliation: School of Psychology,Xavier University,Cincinnati,USA.
authors.forename: N
authors.initials: N
authors.lastname: Salsman
authors.affiliation: Department of Clinical,Neuro and Developmental Psychology,VU University Amsterdam,the Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: Cuijpers
mesh_terms: D003865:Major Depressive Disorder / Q000628:therapy*; D006801:Humans; D020407:Internet; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic; D012648:Self Care / Q000009:adverse effects* / Q000379:methods
keywords: Adverse events; Internet-based guided self-help; depression; deterioration effect; negative effects