NCT04356924 Psychological Treatment to Support the Consequences of Cognitive Impairment
| NCT ID | NCT04356924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2023-09-07 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2023-09-07 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Miia Kivipelto, Professor
STUDY DIRECTOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT04356924 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04356924 currently recruiting?
Yes, NCT04356924 is actively recruiting participants. Contact the research team at urban.ekman@ki.se for enrollment information.
Where is the NCT04356924 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT04356924 clinical trial?
NCT04356924 is sponsored by Karolinska Institutet. The principal investigator is Miia Kivipelto, Professor at Karolinska Institutet. The trial plans to enroll 138 participants.