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Background: Mindfulness has been applied to improve cancer care by enhancing psychological well-being. However, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening functional brain connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast cancer patients after chemotherapy., Methods/design: The present study is a three-arm, parallel-group, randomized controlled trial with assessments at baseline, 1 to 3 weeks after the intervention and at 3 months' follow-up. One hundred and twenty breast cancer patients who ended treatment a minimum of 6 months and a maximum of 5 years before, and who have cognitive complaints, will be enrolled. They will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group (n = 40), (2) an active control condition based on physical training (n = 40), or (3) a treatment as usual (TAU) control group (n = 40). Both the mindfulness-based intervention and the active control condition consist of four group sessions (3 h for the mindfulness condition and 2 h for the physical training) spread over 8 weeks. The primary outcomes will be cognitive symptoms as measured by the Cognitive Failure Questionnaire and changes in functional brain connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness, quality of life; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging and (4) measures of inflammation., Discussion: The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer., Trial Registration: ClinicalTrials.gov, ID: NCT03736460. Retrospectively registered on 8 November 2018.

Background: Depression is a debilitating mental health problem that tends to run a chronic, recurrent course. Even when effectively treated, relapse and recurrence rates remain high. Accordingly, interventions need to focus not only on symptom reduction, but also on reducing the risk of relapse by targeting depression-related disturbances that persist into remission. We are addressing this need by investigating the efficacy, acceptability and feasibility of a MEmory Specificity Training (MEST) programme, which directly targets an enduring cognitive marker of depression - reduced autobiographical memory specificity. Promising pilot data suggest that training memory specificity ameliorates this disturbance and reduces depressive symptoms. A larger, controlled trial is now needed to examine the efficacy of MEST. This trial compares MEST to an education and support (ES) group, with an embedded mechanism study., Methods/design: In a single blind, parallel cluster randomised controlled trial, 60 depressed individuals meeting diagnostic criteria for a current major depressive episode will be recruited from the community and clinical services. Using a block randomisation procedure, groups of 5 to 8 participants will receive five weekly sessions of MEST (n = 30) or education and support (n = 30). Participants will be assessed immediately post-treatment, and at 3- and 6-months post-treatment (MEST group only for 6-month follow-up). Depressive symptoms at 3-month follow-up will be the primary outcome. Secondary outcomes will be change in depressive status and memory specificity at post-treatment and 3-months. The 6-month follow-up of the MEST group will allow us to examine whether treatment gains are maintained. An explanatory question will examine variables mediating improvement in depression symptoms post-treatment and at 3-month follow-up., Discussion: This trial will allow us to investigate the efficacy of MEST, whether treatment gains are maintained, and the mechanisms of change. Evidence will be gathered regarding whether this treatment is feasible and acceptable as a low-intensity intervention. If efficacy can be demonstrated, the results will support MEST as a treatment for depression and provide the foundation for a definitive trial., Trial Registration: NCT01882452 (ClinicalTrials.gov), registered on 18 June 2013.