Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework

Gold, Stefan M.; Enck, Paul; Hasselmann, Helge; Friede, Tim; Hegerl, Ulrich; Mohr, David C.; Otte, Christian

doi:10.1016/s2215-0366(17)30153-0

Cited by 196 publications

(173 citation statements)

References 33 publications

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“…Since CM provides the nonspecific ingredients of the psychotherapeutic approach, significant differences between an experimental treatment and CM are likely to reflect specific ingredients entailed by the experimental approach, unlike what takes place with TAU or WLC. CM should be differentiated from nonspecific factor component control [6], where patients are informed only about treatments available or self-aid options and psychotherapeutic management is missing.…”

Section: Comparison Between Experimental Psychotherapy and Nonspecifimentioning

confidence: 99%

“…The randomized controlled trials (RCT) play the most important role in this process, even though also other forms of investigation may yield valuable information [3][4][5][6][7][8][9]. The methodology for psychological interventions of trials has been discussed in the literature [3,5,6,8,[9][10][11][12][13]. In Psychotherapy and Psychosomatics, specific reference to the selection and design of control conditions has been made [14].…”

mentioning

confidence: 99%

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Methodological Recommendations for Trials of Psychological Interventions

Guidi

Brakemeier

Bockting

et al. 2018

Psychother Psychosom

186

178

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Recent years have seen major developments in psychotherapy research that suggest the need to address critical methodological issues. These recommendations, developed by an international group of researchers, do not replace those for randomized controlled trials, but rather supplement strategies that need to be taken into account when considering psychological treatments. The limitations of traditional taxonomy and assessment methods are outlined, with suggestions for consideration of staging methods. Active psychotherapy control groups are recommended, and adaptive and dismantling study designs offer important opportunities. The treatments that are used, and particularly their specific ingredients, need to be described in detail for both the experimental and the control groups. Assessment should be performed blind before and after treatment and at long-term follow-up. A combination of observer- and self-rated measures is recommended. Side effects of psychotherapy should be evaluated using appropriate methods. Finally, the number of participants who deteriorate after treatment should be noted according to the methods that were used to define response or remission.

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Section: Comparison Between Experimental Psychotherapy and Nonspecifimentioning

confidence: 99%

mentioning

confidence: 99%

Methodological Recommendations for Trials of Psychological Interventions

Guidi

Brakemeier

Bockting

et al. 2018

Psychother Psychosom

186

178

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“…Given limited evidence for effective internet-based fatigue management programmes in MS on one hand and the potential impact such easily scalable approaches would have in clinical care, we feel that the waitlist control group chosen here was appropriate for the current stage of development of our intervention 18. Moreover, there was no indication of a nocebo response in the control group.…”

Section: Discussionmentioning

confidence: 99%

“…A decision framework for appropriate control conditions for clinical trials examining behavioural interventions has recently been published 18. According to this decision framework, participation risk for our patients was low and there is a paucity of evidence from large clinical trials in MS fatigue in general and for the efficacy of online-based therapeutic options for MS-related fatigue in particular.…”

Section: Methodsmentioning

confidence: 99%

“…According to this decision framework, participation risk for our patients was low and there is a paucity of evidence from large clinical trials in MS fatigue in general and for the efficacy of online-based therapeutic options for MS-related fatigue in particular. Thus, a waitlist control group was deemed appropriate for the current stage of development for ELEVIDA 18. Participants randomised to the waitlist control condition were provided with access codes to ELEVIDA after completing the week 24 assessments.…”

Section: Methodsmentioning

confidence: 99%

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Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis

Pöttgen

Moss‐Morris

Wendebourg

et al. 2018

J Neurol Neurosurg Psychiatry

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Evaluation of the Integrated Intervention for Dual Problems and Early Action Among Latino Immigrants With Co-occurring Mental Health and Substance Misuse Symptoms

et al. 2019

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Key Points Question Would a tailored behavioral health intervention reduce substance misuse and mental health symptoms, compared with enhanced usual care, in Latino immigrants with co-occurring mental health and substance misuse symptoms? Findings In this randomized clinical trial from 3 sites of 341 immigrants with co-occurring mental health and substance misuse symptoms, the primary outcome of substance misuse did not change in the intent-to-treat analysis. Patients who received the treatment statistically significantly experienced decreased mental health symptoms, compared with controls under enhanced usual care, and only participants with moderate to severe symptoms who received the intervention statistically significantly reduced their substance misuse. Meaning The intervention did not change drug misuse in a heterogeneous sample but did improve secondary mental health outcomes, a finding that might provide a path for treating Latino immigrants with co-occurring mental health symptoms whose symptoms are in the moderate-to-severe range.

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Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework

Cited by 196 publications

References 33 publications

Methodological Recommendations for Trials of Psychological Interventions

Methodological Recommendations for Trials of Psychological Interventions

Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis

Evaluation of the Integrated Intervention for Dual Problems and Early Action Among Latino Immigrants With Co-occurring Mental Health and Substance Misuse Symptoms

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