Psychological Treatment to Support the Consequences of Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorKarolinska Institutet
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Psychological treatment
BehavioralThe 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.
Cognitive training
BehavioralComputer 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).
Treatment groups
138 Participants
are divided into 3 treatment groupsGroup A: Psychological treatmentExperimental treatment 1 intervention
Group B: Cognitive trainingActive comparator 1 intervention
Group C: Treatment as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
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.Secondary outcomes
1
Change in perceived stress scale (PSS)
Questionnaire measuring stress related symptoms. Scale: 0-40. A low score indicate a more positive outcome.
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.2
Change in Becks Depression Inventory (BDI)
Questionnaire measuring Depression. Scale\_ 0-63. A low score indicate a more positive outcome.
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.3
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.
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.4
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.
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.Sponsors and contacts
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Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov