Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Change in psychological flexibility measured with the Acceptance and action questionnaire (AAQ2)
研究概览
简要总结
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.
详细描述
Background
The burden of cognitive impairment is severe, and often hinders affected people to act independently in daily life, and their families frequently carry a large burden. A great challenge is to support the maintenance of cognitive health in order to avoid cognitive disability. Individuals diagnosed with subjective cognitive decline (SCD [unimpaired performance on cognitive tests]), mild cognitive impairment (MCI [Impaired performance on cognitive tests]) are frequently affected by health issues (such as stress symptoms, anxiety, and depression), as well as social avoidance due to the unclear prognosis of their cognitive dysfunction. Thus, the need for efficient psycho-social support are utterly needed both from an individual- as well as a societal perspective.
The investigators have developed a novel psychological treatment manual focused on supporting individuals with SCD and MCI. 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. 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 with for example with reminders, more sessions, validation techniques, repetition, and concrete examples etc. Recent developments within CBT, particularly acceptance commitment therapy (ACT), emphasize the utility of acceptance and mindfulness strategies, contrasting interventions focused on reduction or control of symptoms. In brief, the treatment objective in ACT and in our study is to improve functioning by increasing psychological flexibility. Psychological flexibility is defined as 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.
The specific research questions are:
- Can the psychological treatment rationale with its focus on psychoeducation, validation, exposure, and acceptance among other therapeutic techniques, preserve cognitive status, increase life satisfaction, improve psychological health, show positive biological changes in individuals with SCD/MCI?
- Are potential treatment effects maintained longitudinally?
- Can significant treatment predictors be identified on treatment outcome?
- How does the participants perceive the treatment?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <
- •Stroke or head trauma < 6 months ago.
- •Substance abuse
排除标准
- 未提供
研究组 & 干预措施
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).
干预措施: Psychological treatment (Behavioral)
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).
干预措施: Cognitive training (Behavioral)
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. However, after the finalization of the post-intervention evaluations, this group will be randomized to participate in one of the active interventions. We will conduct additional post-intervention assessments also for those individuals in this group that accept this offer to increase the power of the intervention evaluation.
结局指标
主要结局
Change in psychological flexibility measured with the Acceptance and action questionnaire (AAQ2)
时间窗: 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.
次要结局
- Change in Becks Depression Inventory (BDI)(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.)
- Change in Brunnsvikens Brief Quality of Life Scale (BBQ)(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.)
- Change in perceived stress scale (PSS)(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.)
- Change in Short Form Health Survey (SF-36)(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.)
- Client Satisfaction Questionnaire (CSQ-8)(Measurement 1: 1 week post-intervention. Measurement 2: Change from 1 week post-intervention at 6-month post intervention.)
- Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)(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.)
- Childhood Trauma Questionnaire (CTQ)(Measurement 1: 1 week prior to the intervention. This questionnaire will be evaluated in respect of predicting treatment outcome.)
- Change in Brief Visuospatial Memory Test Revised (BVMT-R)(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.)
- Change in computer-based AX-Continuous Performance Task (CPT)(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.)
- Change in computer-based reaction time test from Deary-Liewald(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.)
- Change in Design fluency test, D-KEFS(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.)
- Change in Hemoglobin HbA1C(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.)
- Change in C-peptide(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.)
- Change in the computer-based Flanker task(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.)
- Change in brain derived neuro-tropic factor (BDNF)(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.)
- Change in Interleukin 6(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.)
- Change in Cortisol(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.)
- Change in the computer-based Visual Short-Term Memory Binding Test (VSTMBT)(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.)
- Change in Insulin(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.)
研究者
Urban Ekman
Assistant Professor
Karolinska Institutet