Abstract
Background
There is a growing body of research supporting the potential therapeutic value of the Cognitive Control Training (CCT) for depression, even though more research including a control condition is necessary to investigate its working mechanisms.
Methods
The aim of this randomized, double-blind, placebo-controlled trial was to investigate the adjunctive effects of CCT to treatment-as-usual, compared to a sham-training, in patients with Major Depressive Disorder. Hundred-and-fifteen inpatients were randomly assigned to complete ten sessions of either an active working-memory based CCT (n = 56) or a comparable sham-training (n = 59). Changes in depressive symptoms and rumination were assessed from baseline to post-training, and at 1 year follow-up. Secondary outcome measures included alternative indices of maladaptive emotion regulation strategies, state-rumination in response to a worry induction, a cognitive transfer task and self-reports of work-status and well-being at 1 year follow-up.
Results
Our results show no evidence for short-term beneficial effects of CCT in depressed inpatients when added to TAU.
Conclusion
Although other studies suggest that CCT may hold potential as an add-on intervention for depression, our findings point to the importance of investigating individual differences and conditions predicting training response.
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Notes
It should be noted that the pre-registration wrongly mentioned BDI < 11 as an inclusion criterium. Moreover, we have added the BDI as a primary outcome measure, even though it was listed as a secondary outcome measure in the pre-registration. Based on new insights in the field of cognitive remediation, we also consider depressive symptoms and emotion regulation as primary outcome variables, and changes in rumination as a potential mediator. Finally, after an initial pilot test, it became clear that the burden of the pre-registered original protocol was too high for the patients. Therefore, the Internal Shift Task was replaced by the Random Number Generation task.
Results of the analyses on the RSQ subscale Distraction may be affected by the significant baseline between-group difference on this scale.
We had planned to use both self-judgments and rater-judgments of the intrusions. However, the inter-rater reliability was so low (none to slight or fair agreement for the different phases of the task) that only the self-judgments could be used.
Due to missing data on single items of both subscales, the n of the two subscales differs slightly (Expectancy: Active-Trainingn = 47, Sham-Trainingn = 57, Credibility: Active-Trainingn = 50, Sham-Trainingn = 57).
Due to the small sample-size the analysis of the BDI-II follow-up data was based on, this analysis is not considered reliable.
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Funding
The study was funded by the Behavioural Science Institute of Radboud University. The Salus Clinic Lindow provided the rooms and facilities for conducting the study. Neither funding source had any influence on the design or results of the study.
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Gina R. A. Ferrari, Marie-Anne Vanderhasselt, Mike Rinck, Ineke Demeyer, Rudi De Raedt, Silvia Beisel, Johannes Lindenmeyer and Eni S. Becker declare that they have no conflict of interest.
Ethical Approval
This RCT was pre-registered at the Nederlands Trial Register (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5030). The study received ethical approval from the Ethics Committee of the University of Chemnitz, Germany. All procedures performed in the study involving human participants were in accordance with the ethical standards of the ethics committee, and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Ferrari, G.R.A., Vanderhasselt, MA., Rinck, M. et al. A Cognitive Control Training as Add-On Treatment to Usual Care for Depressed Inpatients. Cogn Ther Res 45, 929–943 (2021). https://doi.org/10.1007/s10608-020-10197-y
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DOI: https://doi.org/10.1007/s10608-020-10197-y
Keywords
- Major depression
- Cognitive control training
- PASAT
- Rumination
- RCT