Actively Recruiting
Psychological Treatment to Support the Consequences of Cognitive Impairment
Led by Karolinska Institutet · Updated on 2025-07-01
138
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Psychological Treatment to Support the Consequences of Cognitive Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under 75 years of age
- Diagnosed with subjective cognitive decline (SCD) or mild cognitive impairment (MCI), any subtype
- Mild to moderate psychological symptoms related to cognitive impairment affecting daily life, such as avoidance behavior, social anxiety, or perceived stigmatization
- Fluent in Swedish
- Access to a mobile phone to receive SMS reminders
- Signed informed consent
You will not qualify if you...
- Diagnosis of dementia
- Serious illness or injury requiring immediate treatment or expected to worsen in the next year (not including dementia)
- Severe psychiatric disorders or high suicide risk
- Changes in anti-depressant medication dose within the past 6 months
- Mini Mental State Examination (MMSE) score below 26 or Montreal Cognitive Assessment (MoCA) score below 24
- Stroke or head trauma within the last 6 months
- Substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Stockholm, Stockholm County, Sweden, 17164
Actively Recruiting
Research Team
U
Urban Ekman, PhD
CONTACT
M
Måns Gyllenhammar, PhD student
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here