Psychological treatment for cognitive impairment support
Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI)
This study is testing a new psychological treatment to help people with mild cognitive issues feel better and improve their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Stockholm County) |
| Trial ID | NCT04356924 on ClinicalTrials.gov |
What this trial studies
This study focuses on providing psychological treatment to individuals experiencing cognitive impairment, specifically those with subjective cognitive decline (SCD) and mild cognitive impairment (MCI). The intervention is based on a novel treatment manual that incorporates cognitive behavioral therapy (CBT) principles, adapted to meet the needs of cognitively affected individuals. The approach aims to facilitate behavioral changes aligned with personal values and long-term goals, while addressing associated psychological symptoms such as anxiety and depression. Participants will receive support through reminders and tailored sessions to enhance their daily functioning and quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals under 75 years old diagnosed with subjective cognitive decline or mild cognitive impairment who experience mild to moderate psychological symptoms.
Not a fit: Patients with a diagnosis of dementia or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the psychological well-being and daily functioning of patients with cognitive impairment.
How similar studies have performed: Other studies have shown promise in using psychological interventions for cognitive impairment, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm, Stockholm County
- Karolinska University Hospital — Stockholm, Stockholm County, Sweden (Recruiting)
Study contacts
- Study coordinator: Urban Ekman, PhD
- Email: urban.ekman@ki.se
- Phone: +468-517 713 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.