Psychological Treatment to Support the Consequences of Cognitive Impairment
Launched by KAROLINSKA INSTITUTET · Apr 19, 2020
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new psychological treatment designed to help people who are experiencing early stages of cognitive impairment, which can affect their daily lives and emotional well-being. The researchers aim to see if this treatment can improve mental health and help participants make positive lifestyle changes. They are looking for about 138 individuals who are under 75 years old and have mild to moderate psychological symptoms related to their cognitive impairment, such as anxiety or social avoidance. Participants must also speak Swedish and have a mobile phone for reminders.
Those who join the trial will be randomly assigned to one of three groups: one will receive the new psychological treatment, another will undergo cognitive training, and the third group will continue with their usual care. Throughout the trial, researchers will measure changes in participants' mental health, cognitive abilities, and biological responses. This study is important because it seeks to provide tailored psychological support to those who need it, potentially improving their quality of life during a challenging time.
Gender
ALL
Eligibility criteria
- • Criteria's for inclusion
- • \< 75 years.
- • SCD or MCI diagnosis. All cognitive MCI-subtypes are eligible.
- • Mild to moderate psychological symptoms that are indicated to be related to the patient's CI. The psychological symptoms should affect the patients daily living and behavior, exemplified by avoidance behavior, social anxiety and perceived stigmatization.
- • Fluency in the Swedish language.
- • The patients should have access to a mobile telephone to be able to receive reminders via Short Message Service (SMS).
- • Signed informed consent.
- • Criteria's for exclusion
- • Dementia diagnosis and/or occurrence of serious illness and/or injury that requires immediate investigation or treatment of another type, or which is expected to worsen in the coming year (i.e., not including dementia)
- • Severe psychiatric comorbidity (e.g., high suicide risk), and/or severe psychiatric disorder. This will be assessed in the MINI evaluation and during the clinical cognitive examination).
- • Anti-depressant medication introduced or alterations in dosage \< 6 months ago (i.e., un-stable dose).
- • Mini Mental State Examination (MMSE) score \< 26 and/or a Montreal Cognitive Assessment (MoCA) score \< 24.
- • Stroke or head trauma \< 6 months ago.
- • Substance abuse
About Karolinska Institutet
Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, , Sweden
Patients applied
Trial Officials
Miia Kivipelto, Professor
Study Director
Karolinska Institutet
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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