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Psychological Treatment to Support the Consequences of Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT04356924
Recruitment Status : Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Urban Ekman, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Cognitive Impairment Psychological Psychotherapy Health Behavior Behavioral: Psychological treatment Behavioral: Cognitive training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI)
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 10, 2022
Estimated Study Completion Date : December 10, 2023

Arm Intervention/treatment
Experimental: Psychological treatment
The psychological treatment consists of 11 sessions (55 minutes per occasion), where the patient meets a psychologist face-to-face (either licensed or under training to be licensed) once a week. In between sessions, patients are supposed to complete homework exercises that are related to the contiguous sessions (2 x 45 minutes per week).
Behavioral: Psychological treatment
The treatment is an adjusted (to the cognitively impaired individual) combination of CBT, ACT, validation strategies, and psychoeducation. One focus is to increase motivation to lifestyle changes, and to a larger degree live life in correspondence with internal goals.

Active Comparator: Cognitive training
Like the experimental group, the active control group also consists of 11 sessions (55 minutes per occasion), once a week. At those occasions, the patient will meet a psychology student under training or a MSc in psychology that coaches the patients during the cognitive training. In between sessions, patients are supposed to take 2 walks (45 minutes per occasion to meaningfully match the home exercises in the experimental group).
Behavioral: Cognitive training
Computer based training tasks implemented with adaptive intensity. The cognitive training method that will be used is mainly related to executive control (i.e., ability to coordinate thoughts and actions in accordance with internal goals).

No Intervention: Treatment as usual
This group receives no intervention. They receive regular health information that is given after the extended cognitive examination at the Cognitive Centers.



Primary Outcome Measures :
  1. Change in psychological flexibility measured with the Acceptance and action questionnaire (AAQ2) [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Change in perceived stress scale (PSS) [ Time Frame: 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. ]
    Questionnaire measuring stress related symptoms. Scale: 0-40. A low score indicate a more positive outcome.

  2. Change in Becks Depression Inventory (BDI) [ Time Frame: 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. ]
    Questionnaire measuring Depression. Scale_ 0-63. A low score indicate a more positive outcome.

  3. Change in Brunnsvikens Brief Quality of Life Scale (BBQ) [ Time Frame: 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. ]
    Questionnaire measuring quality of life. Scale: 0-48. A high score indicate a more positive outcome.

  4. Change in Short Form Health Survey (SF-36) [ Time Frame: 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. ]
    Health survey. Scale: Scale: Consist of eight scales that are transformed to 0-100 scales. Lower scores indicate higher disability.

  5. Change in Color-Word Interference Test (CWIT) [ Time Frame: Measurement 1: 1 week prior to the intervention. Measurement 2: Change in CWIT from pre-intervention at 1 week post-intervention. Measurement 3: Change in CWIT from 1 week post-intervention at 6-month post intervention. ]
    Measuring executive functions. Measured in seconds. A high score indicate a poor performance.

  6. Change in Brief Visuospatial Memory Test Revised (BVMT-R) [ Time Frame: 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. ]
    Measuring non-verbal episodic memory. Measured in correct answer. A high score indicate a better performance.

  7. Change in Trail Making Test (TMT) [ Time Frame: Measurement 1: 1 week prior to the intervention. Measurement 2: Change in TMT from pre-intervention at 1 week post-intervention. Measurement 3: Change in TMT from 1 week post-intervention at 6-month post intervention. ]
    Measuring executive functions. Measured in seconds. A high score indicate a poor performance.

  8. Change in AX-Continuous Performance Task (CPT) [ Time Frame: 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. ]
    Measuring executive functions. Measured in correct answers. A high score indicate a good performance.

  9. Change in Digit-Span from Wechsler Adult Intelligence Scale (WAIS):IV [ Time Frame: Measurement 1: 1 week prior to the intervention. Measurement 2: Change in Digit-Span from pre-intervention at 1 week post-intervention. Measurement 3: Change in Digit-Span from 1 week post-intervention at 6-month post intervention. ]
    Measuring working memory. Measured in correct answers. A high score indicate a good performance.

  10. Change in computer-based reaction time test from Deary-Liewald [ Time Frame: 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. ]
    Measuring reaction times. Measured in correct answers. A high score indicate a good performance.

  11. Change in Measure of cortisol in saliva [ Time Frame: Measurement 1: 1 week prior to the intervention. Measurement 2: Change in cortisol from pre-intervention at 1 week post-intervention. Measurement 3: Change in cortisol from 1 week post-intervention at 6-month post intervention. ]
    Biological measures. Low level of cortisol indicate lower stress hormone levels.

  12. Change in Dehydroepiandrosterone (DHEA) [ Time Frame: Measurement 1: 1 week prior to the intervention. Measurement 2: Change in DHEA from pre-intervention at 1 week post-intervention. Measurement 3: Change in DHEA from 1 week post-intervention at 6-month post intervention. ]
    Biological measures. Low level of DHEA indicate lower stress hormone levels.

  13. Change in telomerase activity by modified real-time telomeric repeat amplification protocol [ Time Frame: Measurement 1: 1 week prior to the intervention. Measurement 2: Change in telomerase activity from pre-intervention at 1 week post-intervention. Measurement 3: Change in telomerase activity from 1 week post-intervention at 6-month post intervention. ]
    A biological measure, measuring cellular health. Increased activity indicate an increased cellular activity, and a positive outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A SCD or an MCI diagnosis. SCD or MCI can be due to any underlying conditions.
  • Mild to moderate psychological symptoms that relates to the patient's cognitive impairment. The psychological symptoms should affect the patients daily living and behavior. Examples of behavioral effects are: avoidance behavior, social anxiety, perceived stigmatization etc.
  • 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)
  • The patients must sign an informed consent

Exclusion Criteria:

  • Dementia diagnosis.
  • Severe cerebrovascular disease assessed with the Fazekas visual rating scale (score from 0-3) derived from structural magnetic resonance imaging (MRI). A Fazekas score of 2 or 3 indicates a high white matter signal abnormality and leads to exclusion.
  • Pathological amyloid-β (Aβ42) levels in cerebrospinal fluid. An Aβ42 ≤550 pg/ml indicates AD pathology and leads to exclusion.
  • Severe medial temporal atrophy (MTA) assessed by the MTA visual rating scale (score from 0-4) derived from structural MRI. An MTA score of 3 or 4 indicates severe MTA and leads to exclusion.
  • Has undergone other psychological treatment over the past 6 months
  • Occurrence of serious illness and/or injury that requires immediate investigation or treatment of another character, 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 disease.
  • Anti-depressant medication < 6 months.
  • Mini Mental State Examination score < 26 and/or Montreal Cognitive Assessment (MoCA) score < 24
  • Stroke or head trauma < 6 months ago with persistent symptoms
  • Substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356924


Contacts
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Contact: Urban Ekman, PhD +468-517 713 66 urban.ekman@ki.se
Contact: Ulrika Akenine, PhD student +468-517 713 66 ulrika.akenine@ki.se

Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
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Study Director: Miia Kivipelto, Professor Karolinska Institutet
Publications of Results:

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Responsible Party: Urban Ekman, Assistant Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04356924    
Other Study ID Numbers: KIPT6692021
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urban Ekman, Karolinska Institutet:
Cognitive impairment
Psychological treatment
Dementia prevention
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders