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CORDIAL: Cognitive Rehabilitation and Cognitive-behavioral Treatment for Early Dementia in Alzheimer... Article in Alzheimer disease and associated disorders · October 2011 DOI: 10.1097/WAD.0b013e318231e46e · Source: PubMed
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ORIGINAL ARTICLE
CORDIAL: Cognitive Rehabilitation and Cognitive-behavioral Treatment for Early Dementia in Alzheimer Disease A Multicenter, Randomized, Controlled Trial Alexander Kurz, MD,* Angelika Tho¨ne-Otto, PhD,w Barbara Cramer, PhD,* Silvia Egert, PhD,z Lutz Fro¨lich, MD,y Hermann-Josef Gertz, MD,8 Victoria Kehl, PhD,z Stefan Wagenpfeil, PhD,z and Katja Werheid, PhD#
Abstract: Cognitive rehabilitation (CR) is a promising treatment approach for older adults with dementia because it aims at supporting the management of day-to-day problems. There is insufficient evidence regarding whether CR provides clinically meaningful benefits. In this study, we evaluated the feasibility, acceptance, efficacy, and usefulness of a CR intervention in a multicenter, randomized, controlled trial on 201 patients with mild dementia in Alzheimer disease and their carers. The intervention comprised 12 individual weekly sessions and combined 4 established strategies adopted from neurorehabilitation and psychotherapy. Activities of daily living were chosen as the primary outcome. The results show that the feasibility, treatment adherence, and carer commitment were excellent. However, no effect of the intervention was demonstrable on everyday functioning. There were improvements favoring the intervention on quality of life and treatment satisfaction and a significant antidepressant effect in female participants. The lack of impact on everyday activities may be due to methodological limitations including insufficient personalization, short treatment duration, poor transfer into the real-life setting, and low sensitivity of assessment instruments. The findings of this study may be helpful for designing further studies that are needed to determine the potential of CR in older adults with dementia. Key Words: dementia, Alzheimer disease, cognitive rehabilitation, psychotherapy, randomized controlled trial
(Alzheimer Dis Assoc Disord 2012;26:246–253)
T
he efficacy of current medications for the treatment of Alzheimer disease (AD) is limited to delaying the
Received for publication March 25, 2011; accepted July 24, 2011. From the *Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universita¨t Mu¨nchen; wClinic for Cognitive Neurology; 8Department of Psychiatry and Psychotherapy, Universita¨tsklinikum Leipzig; zMu¨nchner Studienzentrum; yDepartment of Geriatric Psychiatry, Zentralinstitut fu¨r Seelische Gesundheit; Mannheim; zInstitute of Medical Statistics and Epidemiology, Klinikum rechts der Isar, Technische Universita¨t Mu¨nchen; and #Clinical Geriatric Psychology, Institute of Psychology, Humboldt-Universita¨t zu Berlin. The CORDIAL Study was supported by the Federal Ministry of Health (LT-Demenz 44-034) and the Federal Ministry of Education and Research (BMBF grant number GF-GFKN01034607). The authors declare no conflicts of interest. Reprints: Alexander Kurz, MD, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universita¨t Mu¨nchen, Ismaninger Strasse 22, 81675 Munich, Germany (e-mail:
[email protected]). Copyright r 2012 by Lippincott Williams & Wilkins
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progression of symptoms by several months.1 Therefore, nonpharmacological treatments are needed that help affected individuals cope with the functional and emotional consequences of intellectual decline. Ideally, such interventions should provide clinically meaningful benefits in terms of improving or maintaining functional ability,2 enhancing activity and participation, and enabling patients to attain personally relevant goals despite cognitive impairment.3 The feasibility of nonpharmacological treatments focusing on cognition is supported by studies showing that individuals with mild dementia can learn under favorable conditions, and that certain cognitive abilities including procedural memory are relatively spared.4 On these grounds, the potential of cognitive stimulation (CS) and cognitive training (CT) has been explored in older adults with dementia, often in combination with activity programs5 or reminiscence therapy6 aiming at improving mood and quality of life. These studies collectively demonstrate that nonpharmacological interventions involving cognitionfocused components can provide modest benefits on targeted cognitive tasks. These fall short of changes that are deemed clinically meaningful in drug trials7 and are inconsistently associated with changes of behavioral disturbance, mood, and quality of life. Importantly, the impact of CS and CT on patients’ capability of performing everyday tasks has remained questionable.8–11 This may be due to the methodological problems of the studies evaluating the interventions including small sample size, short treatment duration, and poor sensitivity of the assessment instruments. However, the nature of the neurodegenerative process itself may contribute to the lack of clinically meaningful outcomes. It undermines episodic memory, executive function, attention, and awareness of deficits at the earliest clinical stages12 and thus deprives affected individuals of abilities required for learning, recalling, selecting, and applying cognitive strategies in everyday situations.13 In view of these limitations, cognitive rehabilitation (CR) remains a promising treatment modality. Unlike CT, it does not attempt to modify cognitive functions per se but aims at developing and implementing in everyday life strategies such as external memory aids or daily routines that are cognitively less demanding but may help the individual manage day-to-day problems.14 Only a few clinical trials have explored the potential of CR in people with minor cognitive impairment or dementia, showing that these interventions are associated with improvements on memory strategy knowledge and use,
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selected memory functions, and psychological well-being. An impact on activities of daily living was either not addressed15,16 or not demonstrable.17 One recent study showed that a relatively brief, highly personalized intervention of the CR type significantly improved the attainment of personally relevant goals.18 It is unclear to which extent these benefits were mediated by enhancement of functional abilities. Cognitive-behavioral (CB) interventions including enhancement of pleasant activities5 and stimulation of positive memories6 have been shown to reduce depression and improve emotional well-being. In this study, we evaluated a combined CR and CB intervention in patients with mild dementia with regard to feasibility in a multicenter setting, acceptance by patients and carers, and efficacy, focusing on functional ability.
METHODS Participants Those patients who fulfilled the ICD-10 research criteria for dementia in AD19 of mild severity as defined by a Mini Mental State Examination20 score of 21 or above and were looked after by a carer several times per week were included in the study. Criteria precluding participation were acute psychiatric or physical disorders, unavailability of a carer, ongoing formal psychotherapy or cognitive training, regular visits to day care facilities, impending hospital or nursing home admission, poor command of German, alcohol or substance dependence, and participation in another interventional trial. Cholinesterase inhibitors, memantine, nootropics, antidepressants, and antipsychotics at stable doses were permissible as concomitant medications. Written informed consent was obtained from patients and carers before conducting study-related procedures. Randomization was performed centrally and separately for each study site on the basis of a computer-generated randomization list involving a prespecified block size. Group allocation was concealed from outcome raters.
Interventions The intervention consisted of 12 weekly 1-hour sessions, which were organized in 4 thematic modules flanked by an introductory and a closing module. Due to time constraints set by the funding authority, a longer treatment duration was not feasible in combination with a 6-month follow-up assessment. In each thematic module one out of four established treatment strategies were applied. Of these, 2 were taken from neurorehabilitation (use of external memory aids,21 introduction of daily routines22), and 2 strategies were imported from psychotherapy (day structuring and activity planning,5 and reminiscence6). The treatment was carried out in an individual format by experienced behavioral therapists in a multicenter setting of 5 university outpatient units and 5 neuropsychiatric practices. The content and flow of each module were specified in a therapist manual. The individual sessions had an identical formal structure to facilitate orientation by procedural learning. Written suggestions for homework were provided for patients to promote transfer of novel behaviors into the everyday context. Each module comprised 2 sessions, of which 1 was scheduled for attendance by patients and carers to improve carers’ coping ability and to enhance the transfer of newly learned strategies into everyday life. Carers received written r
2012 Lippincott Williams & Wilkins
The CORDIAL Study
information describing the background and content of each module. In the introductory module, after a warmingup section, the concept of the intervention was explained, individual problems were identified, and treatment goals were defined. Module 2 focussed on the use of external memory aids including a calendar and with communication skills. Module 3 focused on establishing behavioral routines to reduce demands on memory. Memory-related problems were identified and ways of coping with these problems using routines were explored. Module 4 stimulated patients to actively engage in reminiscence using biographical materials and other objects of memory. Carers were familiarized with the strategy of validation and were encouraged to apply this technique when communicating about memories with the patient. Module 5 was devoted to structuring the day and activity planning. Patients and carers were prompted to resume former activities and to establish a plan for regular activities. The closing module included a review of the program and of individual goals that had been achieved. Participants rehearsed ways to implement acquired strategies and to organize support. Therapists were familiarized with the treatment manual before study inception, received an intensive 1-day prestudy training and were regularly supervised by the lead therapist (A.T.) during the intervention period. They were instructed to adhere to the manual but were allowed to distribute time flexibly among the 6 modules to accommodate the participants’ individual needs. Treatment fidelity was ensured by session protocols that were regularly reviewed by the lead therapist as part of the supervision scheme. The control condition was the site-specific standard medical management provided to patients with early dementia in AD dementia. It was not standardized and could variably include occupational therapy, physiotherapy, carer counseling, carer support groups, or medication alone.
Outcomes Primary Outcome The primary outcome of the study was the change in functional ability between the baseline and the postintervention assessment. It was ascertained using an established informant-rated scale, which has been used previously in dementia treatment evaluation (Bayer Activities of Daily Living, B-ADL, higher scores indicating greater impairment).23
Secondary Outcomes Change in functional ability from the baseline to the postintervention assessment was also assessed as a secondary outcome using a novel standardized interview [Aachen Functional Item Inventory (AFIB),24 patient and carer rating], which has been developed according to the conceptual framework of the International Classification of Functioning, Disability, and Health. For this study, we selected 50 items from the AFIB item pool, which include cognition-related complex activities of daily living. In terms of item content, this instrument seemed to be particularly suited for the evaluation of a treatment in a sample of participants with mild dementia. Further secondary outcomes were the changes between the baseline and the postintervention assessment on quality of life—Quality of Life in Dementia, DEMQOL, patient and carer rating,25 patient depressive symptoms—Geriatric Depression Scale,26 patient behavioral disturbances—Neuropsychiatric Inventory,27 carer www.alzheimerjournal.com |
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depressive symptoms—Beck Depression Inventory,28 carer burden—Zarit Burden Interview,29 memory—Wechsler Memory Scale Revised Logical Memory,30 attention and executive functioning—Trail Making Test,31 verbal fluency—Regensburg Word Fluency Test,32 and treatment satisfaction—Satisfaction Questionnaire ZUF-8,33 patient and carer rating. Potential long-term effects of the intervention were determined by analyzing changes in the primary outcome and the secondary outcomes from the baseline to the follow-up assessment. The primary outcome and the secondary outcomes were assessed at baseline and after the completion of the intervention (month 3). Secondary outcomes were also assessed at follow-up 6 months later (month 9). The patients’ cognitive ability (Mini Mental Status Examination, German version, MMSE20) and the use of medications (antidementia drugs, antidepressants, antipsychotics, benzodiazepines, hypnotics, antihistamines) were recorded at baseline and followup.
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in the SOLAS software Version 3.0. Secondary analyses of the primary outcome variable were performed on patients treated per protocol (PP population). Secondary study outcomes were subjected to an explorative analysis. Posthoc analyses were performed on the primary outcome variable in patient subgroups defined by age (r74 y vs. >74 y), sex, patient and carer education (no or elementary education vs. intermediate and higher education), cognitive ability at baseline (MMSE
