Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major Depressive Disorder

Berger, Douglas

doi:10.12688/f1000research.6953.1

Cited by 9 publications

(4 citation statements)

References 13 publications

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“…A trial of electro-acupuncture and psychotherapy by Zhu et al (2012) involved a blind data analyst. AsBoutron et al (2008) andBerger (2015) note, it is usually not possible to mask a non-pharmacological…”

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confidence: 99%

Treatment of Internet gaming disorder: An international systematic review and CONSORT evaluation

King

Delfabbro

Wu³

et al. 2017

Clinical Psychology Review

189

157

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Treatment services for Internet gaming disorder are becoming increasingly prevalent worldwide, particularly in East Asia. This international systematic review was designed to appraise the quality standards of the gaming disorder treatment literature, a task previously undertaken by King et al. (2011) prior to the inclusion of Internet gaming disorder in Section III of the DSM-5 and 'Gaming disorder' in the draft ICD-11. The reporting quality of 30 treatment studies conducted from 2007 to 2016 was assessed. Reporting quality was defined according to the 2010 Consolidating Standards of Reporting Trials (CONSORT) statement. The results reaffirmed previous criticisms of these trials, namely: (a) inconsistencies in the definition, diagnosis, and measurement of disordered use; (b) lack of randomization and blinding; (c) lack of controls; and (d) insufficient information on recruitment dates, sample characteristics, and effect sizes. Although cognitive-behavioral therapy has a larger evidence base than other therapies, it remains difficult to make definitive statements on its benefits. Study design quality has not improved over the last decade, indicating a need for greater consistency and standardization in this area. Continuing international efforts to understand the core psychopathology of gaming disorder are vital to developing a model of best practice in treatment.

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confidence: 99%

Treatment of Internet gaming disorder: An international systematic review and CONSORT evaluation

King

Delfabbro

Wu³

et al. 2017

Clinical Psychology Review

189

157

View full text Add to dashboard Cite

show abstract

“…In particular, all primary studies in this meta‐analysis did not perform (or did not report) an appropriate blinding procedure. This is a known issue in psychotherapy research, since RCT on psychotherapy cannot be double‐blinded, and single‐blind studies are rarely performed (Berger, 2015). This aspect should be considered with special attention in future studies, conducted with more rigorous procedures to reduce all possible risks of bias and provide high‐quality evidence.…”

Section: Discussionmentioning

confidence: 99%

The efficacy of telephone‐delivered cognitive behavioral therapy in people with chronic illnesses and mental diseases: A meta‐analysis

et al. 2023

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COVID‐19 pandemic led to an increase of remote treatments, such as telephone‐delivery cognitive behavioral therapy (T‐CBT). To our knowledge, no meta‐analyses studied the effect of T‐CBT in chronic and/or mental illnesses on multiple psychological outcomes. Therefore, our study aims to evaluating the efficacy of T‐CBT compared to other interventions (treatment as usual, TAU, or face‐to‐face CBT). Each effect size (ES) was calculated in Hedges' g and pooled together to produce a mean ES for each outcome (depression, anxiety, mental and physical QoL, worry, coping, and sleep disturbances). The meta‐analysis included 33 studies with a randomized controlled trial design. A large ES was found when comparing the efficacy of T‐CBT against TAU on depression (g = 0.84, p < 0.001), whereas a moderate ES was found on anxiety (g = 0.57; p < 0.001), and a small effect on mental quality of life (g = 0.33, p < 0.001), sleep disturbances (g = 0.37, p = 0.042), coping (g = 0.20, p = 0.016) and worry (g = 0.43, p = 0.001). The meta‐analysis comparing the efficacy of T‐CBT and CBT on depression revealed a not significant pooled ES (g = 0.06, p = 0.466). The results provided evidence that T‐CBT could be to be more effective than TAU conditions in multiple psychological outcomes, and as efficient as face‐to‐face CBT in treating depression.

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“…We do not believe that the relatively high dropout rate had a relevant impact in favor towards iCBIT, since missing values were assumed to be missing-at-random (in the mixed model) or were replaced conservatively. In addition, sensitivity analyses ensured that the effect of iCBIT was not overestimated; (ii) the sample size of the f2f CBIT group was smaller than that of the iCBIT and the placebo groups, since f2f CBIT could only be offered at one single center in Hanover, which limited statistical analyses, since this study was not powered for the key secondary non-inferiority analysis; and (iii) since in general participants in studies investigating psychotherapeutic interventions are actively involved in the therapy [ 39 ], double-blinding was impossible. However, since several precautions were undertaken to keep the raters blind, we believe that our data are not biased by unintentional unblinding of the raters.…”

Section: Discussionmentioning

confidence: 99%

ONLINE-TICS: Internet-Delivered Behavioral Treatment for Patients with Chronic Tic Disorders

Haas

Jakubovski

Kunert

et al. 2022

JCM

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Comprehensive Behavioral Intervention for Tics (CBIT) is considered a first-line therapy for tics. However, availability of CBIT is extremely limited due to a lack of qualified therapists. This study is a multicenter (n = 5), randomized, controlled, observer-blind trial including 161 adult patients with chronic tic disorders (CTD) to provide data on efficacy and safety of an internet-delivered, completely therapist-independent CBIT intervention (iCBIT Minddistrict®) in the treatment of tics compared to placebo and face-to-face (f2f) CBIT. Using a linear mixed model with the change to baseline of Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) as a dependent variable, we found a clear trend towards significance for superiority of iCBIT (n = 67) over placebo (n = 70) (−1.28 (−2.58; 0.01); p = 0.053). In addition, the difference in tic reduction between iCBIT and placebo increased, resulting in a significant difference 3 (−2.25 (−3.75; −0.75), p = 0.003) and 6 months (−2.71 (−4.27; −1.16), p < 0.001) after the end of treatment. Key secondary analysis indicated non-inferiority of iCBIT in comparison to f2f CBIT (n = 24). No safety signals were detected. Although the primary endpoint was narrowly missed, it is strongly suggested that iCBIT is superior compared to placebo. Remarkably, treatment effects of iCBIT even increased over time.

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Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major Depressive Disorder

Cited by 9 publications

References 13 publications

Treatment of Internet gaming disorder: An international systematic review and CONSORT evaluation

Treatment of Internet gaming disorder: An international systematic review and CONSORT evaluation

The efficacy of telephone‐delivered cognitive behavioral therapy in people with chronic illnesses and mental diseases: A meta‐analysis

ONLINE-TICS: Internet-Delivered Behavioral Treatment for Patients with Chronic Tic Disorders

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