NCT04356924 · RECRUITING
Psychological Treatment to Support the Consequences of Cognitive Impairment
This trial is testing a talk-therapy program — rooted in cognitive behavioral therapy — designed specifically for people in the early stages of cognitive decline. Researchers want to know whether it eases anxiety, depression, and avoidance behaviors better than cognitive training or standard care. It is a Phase NA randomized controlled trial, meaning it is evaluating a behavioral approach rather than a drug, and RCT status means it is a real head-to-head comparison, not just observational.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-07-01