How to prove that your therapy is effective, even when it is not: a guideline

Cuijpers, Pim; Cristea, Ioana A.

doi:10.1017/s2045796015000864

Cited by 95 publications

(78 citation statements)

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“…They significantly outperformed control conditions in improving depressive symptoms, anxiety symptoms (generalized anxiety and social anxiety), stress levels, general psychiatric distress, quality of life, and positive affect, with effect sizes ranging from g=0.28 to g=0.58. Crucially, these effects were robust even after performing various sensitivity analyses that adjusted for common biasing factors in RCTs, including the type of control condition, trial risk of bias rating, and publication bias.…”

Section: Discussionmentioning

confidence: 94%

The efficacy of app‐supported smartphone interventions for mental health problems: a meta‐analysis of randomized controlled trials

et al. 2019

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Although impressive progress has been made toward developing empirically-supported psychological treatments, the reality remains that a significant proportion of people with mental health problems do not receive these treatments. Finding ways to reduce this treatment gap is crucial. Since app-supported smartphone interventions are touted as a possible solution, access to up-to-date guidance around the evidence base and clinical utility of these interventions is needed. We conducted a meta-analysis of 66 randomized controlled trials of app-supported smartphone interventions for mental health problems. Smartphone interventions significantly outperformed control conditions in improving depressive (g=0.28, n=54) and generalized anxiety (g=0.30, n=39) symptoms, stress levels (g=0.35, n=27), quality of life (g=0.35, n=43), general psychiatric distress (g=0.40, n=12), social anxiety symptoms (g=0.58, n=6), and positive affect (g=0.44, n=6), with most effects being robust even after adjusting for various possible biasing factors (type of control condition, risk of bias rating). Smartphone interventions conferred no significant benefit over control conditions on panic symptoms (g=-0.05, n=3), post-traumatic stress symptoms (g=0.18, n=4), and negative affect (g=-0.08, n=5). Studies that delivered a cognitive behavior therapy (CBT)-based app and offered professional guidance and reminders to engage produced larger effects on multiple outcomes. Smartphone interventions did not differ significantly from active interventions (face-to-face, computerized treatment), although the number of studies was low (n≤13). The efficacy of app-supported smartphone interventions for common mental health problems was thus confirmed. Although mental health apps are not intended to replace professional clinical services, the present findings highlight the potential of apps to serve as a cost-effective, easily accessible, and low intensity intervention for those who cannot receive standard psychological treatment.

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Section: Discussionmentioning

confidence: 94%

The efficacy of app‐supported smartphone interventions for mental health problems: a meta‐analysis of randomized controlled trials

et al. 2019

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“…A third reason why the effects of psychotherapy have been overestimated is that many trials have used waiting list control groups. Although all control conditions in psychotherapy trials have their own problems, the improvement found in patients on waiting lists has been found to be lower than that expected on the basis of spontaneous remission. It has been suggested, therefore, that waiting list is in fact a “nocebo” (the opposite of a placebo; an inert treatment that appears to cause an adverse effect) and that trials using it considerably overestimate the effects of psychological treatments.…”

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confidence: 99%

How effective are cognitive behavior therapies for major depression and anxiety disorders? A meta‐analytic update of the evidence

et al. 2016

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We report the current best estimate of the effects of cognitive behavior therapy (CBT) in the treatment of major depression (MDD), generalized anxiety disorder (GAD), panic disorder (PAD) and social anxiety disorder (SAD), taking into account publication bias, the quality of trials, and the influence of waiting list control groups on the outcomes. In our meta-analyses, we included randomized trials comparing CBT with a control condition (waiting list, care-as-usual or pill placebo) in the acute treatment of MDD, GAD, PAD or SAD, diagnosed on the basis of a structured interview. We found that the overall effects in the 144 included trials (184 comparisons) for all four disorders were large, ranging from g50.75 for MDD to g50.80 for GAD, g50.81 for PAD, and g50.88 for SAD. Publication bias mostly affected the outcomes of CBT in GAD (adjusted g50.59) and MDD (adjusted g50.65), but not those in PAD and SAD. Only 17.4% of the included trials were considered to be high-quality, and this mostly affected the outcomes for PAD (g50.61) and SAD (g50.76). More than 80% of trials in anxiety disorders used waiting list control groups, and the few studies using other control groups pointed at much smaller effect sizes for CBT. We conclude that CBT is probably effective in the treatment of MDD, GAD, PAD and SAD; that the effects are large when the control condition is waiting list, but small to moderate when it is care-as-usual or pill placebo; and that, because of the small number of high-quality trials, these effects are still uncertain and should be considered with caution.Key words: Cognitive behavior therapy, major depression, generalized anxiety disorder, panic disorder, social anxiety disorder, meta-analysis, publication bias, quality of trials, waiting list control groups (World Psychiatry 2016;15:245-258) Every year almost 20% of the general population suffers from a common mental disorder, such as depression or an anxiety disorder 1 . These conditions not only result in personal suffering for patients and their families, but also in huge economic costs, in terms of both work productivity loss and health and social care expenditures 2-6 .Several evidence-based treatments are available for common mental disorders, including pharmacological and psychological interventions. Many patients receive pharmacological treatments, and these numbers are increasing in high-income countries 7 . Psychological treatments are equally effective in the treatment of depression 8 and anxiety disorders [9][10][11] . However, they are less available or accessible 12 , especially in low-and middle-income countries. At the same time, about 75% of patients prefer psychotherapy over the use of medication 13 . The most extensively tested form of psychotherapy is cognitive behavior therapy (CBT). Dozens of trials and several meta-analyses have shown that CBT is effective in treating depression 8,14 and anxiety disorders 9-11 . However, in recent years, it has become clear that the effects of CBT and other psychotherapies have been considerably ...

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“…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].…”

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confidence: 99%

Methodological Recommendations for Trials of Psychological Interventions

Guidi

Brakemeier

Bockting

et al. 2018

Psychother Psychosom

189

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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How to prove that your therapy is effective, even when it is not: a guideline

Abstract: Several methods are available to help you show that your therapy is effective, even when it is not.

Cited by 95 publications

References 50 publications

The efficacy of app‐supported smartphone interventions for mental health problems: a meta‐analysis of randomized controlled trials

The efficacy of app‐supported smartphone interventions for mental health problems: a meta‐analysis of randomized controlled trials

How effective are cognitive behavior therapies for major depression and anxiety disorders? A meta‐analytic update of the evidence

Methodological Recommendations for Trials of Psychological Interventions

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