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RECRUITING
NCT04356924
NA

Psychological Treatment to Support the Consequences of Cognitive Impairment

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

The burden of cognitive impairment is severe, and often hinders affected people to act independently in daily life. Individuals in different stages of cognitive decline are frequently affected by existential distress and associated health issues (such as stress symptoms, anxiety, and depression), as well as social avoidance due to the unclear prognosis. Although the need for psychological support is large, there is a lack of efficient individualized psychological treatments- and methods to maintain psychological health that sufficiently impact daily life and promote behavioral- and biological change. In keeping with that notion, the investigators have developed a novel psychological treatment manual focused on supporting individuals with early phase cognitive impairment. The treatment manual is centered on facilitating behavioral change in accordance with personal values and long-term goals even in the presence of negative experiences, as well as to promote meaningful life-style changes. Conceptually, the treatment manual has its basis in the cognitive behavioral therapy (CBT) tradition, but the investigators have strived to adapt the manual to suit a cognitively affected population. The investigators will evaluate the psychological treatment in a RCT were the investigators will include approximately 138 individuals in their early phases of cognitive decline and randomize them into either an experimental group (psychological treatment), an active control group (cognitive training), or a treatment as usual control group. Evaluations will be conducted with, psychological health measures, cognitive assessments, and with biological markers. The investigators hypothesize that in comparison with the control conditions, the response to psychological treatment will be associated with improved psychological health and improved cellular protection.

Official title: Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI)

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2023-09-07

Completion Date

2028-06-30

Last Updated

2025-07-01

Healthy Volunteers

No

Interventions

BEHAVIORAL

Psychological treatment

The treatment is an adjusted (to the cognitively impaired individual) combination of CBT, ACT, validation strategies, and psychoeducation. One focus is to increase motivation to lifestyle changes, and to a larger degree live life in correspondence with internal goals.

BEHAVIORAL

Cognitive training

Computer based training tasks implemented with adaptive intensity. The cognitive training method that will be used is mainly related to executive control (i.e., ability to coordinate thoughts and actions in accordance with internal goals).

Locations (1)

Karolinska University Hospital

Stockholm, Stockholm County, Sweden