Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder

Meister, Richard; Wolff, Alessa von; Mohr, Hannes; Nestoriuc, Yvonne; Härter, Martin; Hölzel, Lars P.; Kriston, Levente

doi:10.1016/j.jclinepi.2015.10.007

Cited by 38 publications

(48 citation statements)

References 59 publications

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“…Consequently, significant limitations refer to the validity of the adverse event assessments. The method of measuring adverse events through an actual interaction of therapist and patient (i.e., the therapist asking the patient about adverse events with a structured checklist including open‐ended items), on the other hand, avoids limitations of other instrument for assessing adverse events during psychotherapeutic interventions that solely focus on either the patients' or the therapists' perspective (Meister, von Wolff, Mohr, Nestoriuc et al, ).…”

Section: Discussionmentioning

confidence: 99%

“…Adverse events during pharmacologic interventions including antidepressants have a long research tradition and are routinely collected in randomized controlled trials (Meister, von Wolff, Mohr, Nestoriuc et al, ). Thus, adverse events during the intake of antidepressants are well understood and are considered in the treatment decision process.…”

Section: Introductionmentioning

confidence: 99%

“…Typical adverse events include gastrointestinal symptoms, weight gain, sexual dysfunctions, or cardiovascular disturbances (Carvalho, Sharma, Brunoni, Vieta, & Fava, ; Meister, von Wolff, Mohr, Härter et al, ). Adverse events during psychotherapy, on the other hand, have been ignored in research and in clinical practice for a long time (Duggan, Parry, McMurran, Davidson, & Dennis, ; Meister, von Wolff, Mohr, Nestoriuc et al, ; Vaughan, Goldstein, Alikakos, Cohen, & Serby, ).…”

Section: Introductionmentioning

confidence: 99%

“…So far, it is no standard to systematically assess adverse events that may occur during randomized controlled psychotherapy trials. Systematic reviews of such randomized controlled psychotherapy trials show that adverse events are either reported unsystematically (in rare cases) or not reported at all (in most cases; Duggan et al, ; Meister, von Wolff, Mohr, Nestoriuc et al, ; Vaughan et al, ). Consequently, there is no randomized controlled trial that allows us to compare the adverse events profiles of different psychotherapies in detail.…”

Section: Introductionmentioning

confidence: 99%

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Adverse events during a disorder‐specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression

et al. 2019

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Objectives A recent trial comparing Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and supportive psychotherapy in chronic depression found CBASP to be more effective in treating depressive symptoms. We aimed to evaluate adverse events that occurred during this trial. Materials and Method A randomized trial of chronically depressed outpatients was performed. The treatment included 32 sessions of CBASP or supportive psychotherapy. Therapists asked patients about adverse events and their intensity in each session using a standardized checklist. We analyzed the mean number of (severe) adverse events per patient up to Session 32 with gamma frailty recurrent event models. Results Two hundred and sixty patients were included in the analyses (66% female, mean age 45 years). Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group. Less adverse events related to suicidal thoughts were reported in the CBASP compared with the supportive psychotherapy group. Conclusions Differences in the adverse events profile may be explained by the treatment elements. Adverse events related to personal and occupational life for example might be considered a necessary and expected yet temporary adverse treatment outcome of an effective CBASP treatment.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Adverse events during a disorder‐specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression

et al. 2019

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“…First, an inpatient setting allows fast reactivity of the medical team in case of poor compliance to the technique or major adverse events (two patients had a clinically significant depressive episode after the onset of SB) [28,29]. Second, a substantial proportion of our patients had AN, psychiatric co-morbidities, and/or a large number of binge episodes at admission.…”

Section: Methodsmentioning

confidence: 99%

The Sequential Binge, a New Therapeutic Approach for Binge Eating: A Pilot Study

Neveu

Barbalat

et al. 2016

PLoS ONE

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Background and ObjectivesA sizeable proportion of patients experiencing binge eating do not respond to cognitive behavioral therapy (CBT). We present the sequential binge (SB), a new behavioral intervention that complements CBT, and preliminary results of its effects. SB breaks up the binge into repeated identical sequences of eating separated by incremental pauses. This pattern of ingestion aims at facilitating boredom toward the ingested foods and at turning cognitive control away from binge food restriction. SB is hypothesized to reduce food intake during the binge and the number of daily binges.MethodsProspective pilot study. Fifteen binging patients with previous unsuccessful intensive CBT were given SB as an adjunct to their treatment and were followed up for 16 weeks from admission. All patients were reassessed 47 weeks on average after discharge.ResultsSB was associated with a 44% relative reduction in the planned food intake (p<0.001), a longer consecutive binge refractory period compared to regular binges (median: 48 hours versus 4 hours, p = 0.002) and an average relative reduction by 26% of binge number the day after each SB (p = 0.004). 47% of patients reached binge abstinence for four consecutive weeks 16 weeks after the first SB.ConclusionThis case series shows promising evidence for the use of SB in patients with refractory binge eating. Further evaluation in a prospective randomized controlled trial would be justified.

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Comparative effectiveness of continuation and maintenance treatments for persistent depressive disorder in adults

Machmutow

Meister

Jansen

et al. 2019

Cochrane Database of Systematic Reviews

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Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder

Cited by 38 publications

References 59 publications

Adverse events during a disorder‐specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression

Adverse events during a disorder‐specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression

The Sequential Binge, a New Therapeutic Approach for Binge Eating: A Pilot Study

Comparative effectiveness of continuation and maintenance treatments for persistent depressive disorder in adults

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