Cognitive Impairment Clinical Trial
Official title:
Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI)
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.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility | - 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 |
Country | Name | City | State |
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Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Karolinska University Hospital |
Sweden,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in psychological flexibility measured with the Acceptance and action questionnaire (AAQ2) | A psychological health measure (questionaire) measuring the ability to notice and accept interfering thoughts, emotions and bodily sensations without acting on them, to facilitate behaving in accordance with personal values and long-term goals also in the presence of those negative experiences. Scores: 0-49 A low score indicate a more positive outcome. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change in AAQ2 from pre-intervention at 1 week post-intervention. Measurement 3: Change in AAQ2 from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in perceived stress scale (PSS) | Questionnaire measuring stress related symptoms. Scale: 0-40. A low score indicate a more positive outcome. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change in PSS from pre-intervention at 1 week post-intervention. Measurement 3: Change in PSS from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Becks Depression Inventory (BDI) | Questionnaire measuring Depression. Scale_ 0-63. A low score indicate a more positive outcome. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change in BDI from pre-intervention at 1 week post-intervention. Measurement 3: Change in BDI from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Brunnsvikens Brief Quality of Life Scale (BBQ) | Questionnaire measuring quality of life. Scale: 0-48. A high score indicate a more positive outcome. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change in BBQ from pre-intervention at 1 week post-intervention. Measurement 3: Change in BBQ from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Short Form Health Survey (SF-36) | Health survey. Scale: Scale: Consist of eight scales that are transformed to 0-100 scales. Lower scores indicate higher disability. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change in SF-36 from pre-intervention at 1 week post-intervention. Measurement 3: Change in SF-36 from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Generalized Anxiety Disorder 7-item Scale (GAD-7) | Anxiety estimate. Scale 0-3. A low score indicate a more positive outcome. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Childhood Trauma Questionnaire (CTQ) | Questionnaire to identify and measure the prevalence of retrospective childhood trauma. A low score indicate a more positive outcome. Total score is 140, and a low score indicate a more positive outcome. | Measurement 1: 1 week prior to the intervention. This questionnaire will be evaluated in respect of predicting treatment outcome. | |
Secondary | Client Satisfaction Questionnaire (CSQ-8) | A global measure of client satisfaction with the intervention. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. | Measurement 1: 1 week post-intervention. Measurement 2: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Brief Visuospatial Memory Test Revised (BVMT-R) | Measuring non-verbal episodic memory. Measured in correct answer. A high score indicate a better performance. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change in BVMT-R from pre-intervention at 1 week post-intervention. Measurement 3: Change in BVMT-R from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in computer-based AX-Continuous Performance Task (CPT) | Measuring executive functions. Measured in correct answers. A high score (correct answers) and fast response times indicate a good performance. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change in AX-CPT from pre-intervention at 1 week post-intervention. Measurement 3: Change in AX-CPT from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in computer-based reaction time test from Deary-Liewald | Measuring reaction times. Measured in correct answers. A high score indicate a good performance. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change in Deary-Liewald from pre-intervention at 1 week post-intervention. Measurement 3: Change in Deary-Liewald from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Design fluency test, D-KEFS | Measure aspects of executive functions. Measured in correct answers. A high score (correct answers) and fast response times indicate a good performance. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in the computer-based Flanker task | Measure aspects of executive functions such as inhibition. Measured in correct answers. A high score (correct answers) and fast response times indicate a good performance. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in the computer-based Visual Short-Term Memory Binding Test (VSTMBT) | Involves, in the short-time perspective, the ability to hold information in memory especially the integration between surface features, such as shapes and colours | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in brain derived neuro-tropic factor (BDNF) | A biological blood measure, measuring cellular health. Increased activity indicate an increased cellular activity, and a positive outcome. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Interleukin 6 | A biological blood measure. Increased interleukin-6 level may be an independent risk factor for disease severity. Thus, we expect lowered levels as a consequence of the interventions. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Hemoglobin HbA1C | A blood measure that shows the average blood sugar (glucose) level over the past two to three months. Increased HbA1C level may be an independent risk factor for disease severity. Thus, we expect lowered levels as a consequence of the interventions. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Cortisol | A hormone made by the adrenal glands. It helps the body respond to stress etc. Increased Cortisol level may be an independent risk factor for disease severity. Thus, we expect lowered levels as a consequence of the interventions. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in C-peptide | A measure of pancreatic beta cell function. C-peptide has previously been shown to be negatively correlated with depression level. Thus, we expect than increased C-peptide levels as a consequence of the interventions. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. | |
Secondary | Change in Insulin | A hormone that regulates the level of sugar (glucose) in the blood. Previous results indicate that there can be a link between blood sugar dysregulation and mood disorders. We expect increased insulin levels as a consequence of the interventions. | Measurement 1: 1 week prior to the intervention. Measurement 2: Change from pre-intervention at 1 week post-intervention. Measurement 3: Change from 1 week post-intervention at 6-month post intervention. |
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