Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI): Study Protocol of a Randomized Controlled Trial

Urban Ekman, Mike K Kemani, John Wallert, Rikard K Wicksell, Linda Holmström, Tiia Ngandu, Anna Rennie, Ulrika Akenine, Eric Westman, Miia Kivipelto, Urban Ekman, Mike K Kemani, John Wallert, Rikard K Wicksell, Linda Holmström, Tiia Ngandu, Anna Rennie, Ulrika Akenine, Eric Westman, Miia Kivipelto

Abstract

Background: Individuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues (including symptoms of stress, anxiety, and depression). The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention (Psychological Intervention tailored for Patients with Cognitive Impairment, PIPCI) manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial (RCT)-design and methods. The main hypothesis is that participants receiving PIPCI will increase their psychological flexibility (the ability to notice and accept interfering thoughts, emotions, and bodily sensations without acting on them, when this serves action in line with personal values) compared to participants in the active control (cognitive training) group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health (stress measures, quality of life, depression, and general health) compared to participants in the active control group and the waiting list control group.

Materials and methods: This three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group (psychological intervention once a week for 10 weeks), an active control group (cognitive training once a week for 10 weeks) or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers (obtained from blood and saliva) and health care costs. Assessments will be performed at pre- (1 week before the interventions) and post-intervention (1 week after the interventions), as well as at a 6-month follow-up.

Discussion: The development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment (PIPCI) has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia.

Clinical trial registration: ClinicalTrials.gov: NCT04356924. Date of registration: April 22, 2020. URL: https://ichgcp.net/clinical-trials-registry/NCT04356924.

Keywords: acceptance commitment therapy (ACT); cognitive behavioral therapy (CBT); cognitive impairment; prevention; psychological intervention; randomized controlled trial (RCT).

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2020 Ekman, Kemani, Wallert, Wicksell, Holmström, Ngandu, Rennie, Akenine, Westman and Kivipelto.

Figures

FIGURE 1
FIGURE 1
Illustrating a CONSORT (Schulz et al., 2010) inspired flow-chart of the trial design. PIPCI, Psychological Intervention tailored for Patients with early Cognitive Impairment.
FIGURE 2
FIGURE 2
Illustrating a SPIRIT diagram of enrolment, intervention, and assessments. PIPCI, Psychological Intervention tailored for Patients with early Cognitive Impairment; MINI, Mini International Neuropsychiatric Interview; AAQ-II, Acceptance and action questionnaire – second version; PSS, Perceived Stress Scale; BDI, Becks Depression Inventory; BBQ, Brunnsvikens Brief Quality of Life Scale; SF-36, Short Form Health Survey; CWIT, Color Word Interference Test; TMT, Train Making Test; BVMT-R, Brief Visiospatial Memory Test Revised; AX-CPT, AX-Continuous Performance Task; D-LRTT, Deary-Liewald Reaction Time Task; ACTH, adrenocorticotropic hormone; DHEA, dehydroepiandrosterone; CTQ, Childhood Trauma Questionnaire; CSQ, Client Satisfaction Questionnaire.
FIGURE 3
FIGURE 3
Power calculation. The sample size estimate is based on changes in our primary outcome, AAQ-II. The figure illustrates a power curve function to explore trade-offs between power and sample size. The analysis showed that a significant difference between the experimental group and the active control group require at least 35 participants (to have 93% power) in each group. Error bars = standard deviation.

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