A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol.

BACKGROUND: Already a major health concern, late-life depression (LLD) is expected to form an increasing problem in the aging population. Moreover, despite current treatments, LLD is associated with a poor long-term prognosis and high rate of chronicity. Treatment provision and treatment accordingly warrant improvement, where add-on treatments might contribute to the efficacy of conventional therapies. Although it is known that impaired cognitive control contributes to LDD, it is not targeted sufficiently by current interventions. Research on cognitive control training (CCT) shows promising results on depressive symptoms, cognitive performance, and overall functioning. However, further research is needed to determine the long-term effects of CCT on LLD, its cost-effectiveness, and mechanisms of change. METHODS: In the current multicenter randomized controlled trial (RCT) with a between-subjects design participants aged 60 years and over with a current LLD receiving treatment as usual (TAU) are randomized to add-on CCT or placebo training. Randomization is stratified by depression severity. Participants will receive eight online CCT or placebo sessions spread across four consecutive weeks. They will complete a post-training assessment after 1 month and three follow-up assessments scheduled three, six and 12 months after completing the training. We expect CCT and TAU to be more (cost-)effective in reducing depressive symptoms than placebo training and TAU. Additionally, we will be looking at secondary clinical, cognitive and global functioning outcomes and likely mechanisms of change (e.g., improved cognitive functioning, reduced rumination, and improved inhibition of negative stimuli). DISCUSSION: The proposed RCT aims to contribute to the clinical and scientific knowledge on the long-term effects of CCT as an add-on treatment for LLD. Cost-effectiveness is particularly relevant considering the expected volume of the target demographic. The study will be a pragmatic trial with few inclusion restrictions, providing information on feasibility of web-based trainings in clinical settings. The outcomes are potentially generalizable to guidelines for treatment of LLD. TRIAL REGISTRATION: This trial is registered in the Netherlands Trial Register (code: NL7639 ). Registered 3 april 2019.

Exercise enhances: study protocol of a randomized controlled trial on aerobic exercise as depression treatment augmentation.

BACKGROUND: Major depressive disorder (MDD) is a considerable public health concern. In spite of evidence-based treatments for MDD, many patients do not improve and relapse is common. Therefore, improving treatment outcomes is much needed and adjunct exercise treatment may have great potential. Exercise was shown to be effective as monotherapy for depression and as augmentation strategy, with evidence for increasing neuroplasticity. Data on the cost-effectiveness and the long-term effects of adjunct exercise treatment are missing. Similarly, the cognitive pathways toward remission are not well understood. METHODS: The present study is designed as a multicenter randomized superiority trial in two parallel groups with follow-up assessments up to 15 months. Currently depressed outpatients (N = 120) are randomized to guideline concordant Standard Care (gcSC) alone or gcSC with adjunct exercise treatment for 12 weeks. Randomization is stratified by gender and setting, using a four, six, and eight block design. Exercise treatment is offered in accordance with the NICE guidelines and empirical evidence, consisting of one supervised and two at-home exercise sessions per week at moderate intensity. We expect that gcSC with adjunct exercise treatment is more (cost-)effective in decreasing depressive symptoms compared to gcSC alone. Moreover, we will investigate the effect of adjunct exercise treatment on other health-related outcomes (i.e. functioning, fitness, physical activity, health-related quality of life, and motivation and energy). In addition, the mechanisms of change will be studied by exploring any change in rumination, self-esteem, and memory bias as possible mediators between exercise treatment and depression outcomes. DISCUSSION: The present trial aims to inform the scientific and clinical community about the (cost-)effectiveness and psychosocial mechanisms of change of adjunct exercise treatment when implemented in the mental health service setting. Results of the present study may improve treatment outcomes in MDD and facilitate implementation of prescriptive exercise treatment in outpatient settings. TRIAL REGISTRATION: This trial is registered within the Netherlands Trial Register (code: NL8432 , date: 6th March, 2020).