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Status:

RECRUITING

Psychological Treatment to Support the Consequences of Cognitive Impairment

Lead Sponsor:

Karolinska Institutet

Collaborating Sponsors:

Karolinska University Hospital

Conditions:

Cognitive Impairment

Psychological

Eligibility:

All Genders

45-75 years

Phase:

NA

Brief 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 exis...

Detailed Description

Background The burden of cognitive impairment is severe, and often hinders affected people to act independently in daily life, and their families frequently carry a large burden. A great challenge is...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 7 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2028

    Estimated Enrollment :

    138 Patients enrolled

    Trial Details

    Trial ID

    NCT04356924

    Start Date

    September 7 2023

    End Date

    June 30 2028

    Last Update

    July 1 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Karolinska University Hospital

    Stockholm, Stockholm County, Sweden, 17164