Clinical trial NCT02013518: Cognitive Behavioural Therapy for Persons With MCI or Mild Dementia
Official title: Cognitive Behavioural Therapy for Persons With Mild Cognitive Impairment or Dementia in the Early Stages
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimers' Disease
Keywords: Alzheimers' disease
Cognitive behavioral therapy
Depression
Self-efficacy
Quality of Life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sykehuset i Vestfold HF
name: Sykehuset Innlandet HF
First posted: 2013-12-17
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A total of 200 home dwelling participants, who fulfil the inclusion criteria, Alzheimer's disease, will be recruited from three hospitals in Norway.

The intervention is based on a standardized manual, and consists of 11 weekly one-hour sessions, which are organized into six thematic modules.

The content of each session is specified by a treatment manual, which additionally consists of worksheets, suggestions for homework in between sessions and letters to the caregivers (the German manual: Werheid \& Thöne-Otto, 2010; the Norwegian manual: Ulstein, Gordner \& Tonga, not published). The treatment will be conducted by experienced health staff (nurses, psychologist, doctors) with formal training in Cognitive Behavioural Therapy, and knowledge about Alzheimer's Disease. Furthermore, the health staff will be familiarised with the manual before study inception, participate in a two-day training seminar and will regularly be supervised.

The control condition will be offered treatment as usual at the participating the memory clinics.

The hypothesis is that the participants in the intervention group will report less depression and increased self efficacy as compared with the control group.

We conducted a pilot study with 10 patients, 5 in each group, from March to June 2013 to examine the feasibility of the study protocol and do want to include these patients in the study population.


Eligibility criteria: Inclusion Criteria:

A diagnosis of dementia (Alzheimers disease or mixed Alzheimer and vascular dementia) within the past twelve months, consistent with the ICD-10.

Mini Mental Examination score of twenty or above Cornell Depression Scale score of five or above A career who is willing to participate in the interventions, as this is part of the treatment programme. A carer is here defined as the main person responsible for the informal care for the patient and who has regular weekly contact with the patient.

Exclusion Criteria:

Severe somatic or psychiatric comorbid diagnoses, including alcohol and substance abuse, that would impair their cooperation in the intervention programme Dementia with Lewy bodies and frontotemporal dementia, as the intervention is considered to be too cognitively challenging for these patients Poor command of Norwegian Ongoing psychotherapy

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Primary outcomes:
measure: Number of participants reporting decrease in depression scores
timeFrame: Up to nine month
Secondary outcomes:
measure: Number of participants reporting increased Self-efficacy
timeFrame: Up to 9 month
measure: Number of participants reporting increased Quality of Life
timeFrame: Up to 9 month
measure: Number of participants reporting change in cognitive function
timeFrame: Up to 9 month
measure: Number of participating caregivers reporting decreased burden of care
timeFrame: 3 month and 9 month
Other outcomes:
measure: Number of participants reporting satisfaction with the intervention programme
timeFrame: Up to 9 month
measure: Number of participants with a decreased number and severity of neuropsychiatric symptoms
timeFrame: Up to 9 month
measure: Use and costs of health care services
timeFrame: Up to 9 month
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Old Age Psychiatric Department, Oslo Univeristy Hospital, slottsberget 35, 1385 Asker, Norway
name: Ingun D Ulstein, MD PhD
role: STUDY_CHAIR
References:
citation: Kurz A, Thone-Otto A, Cramer B, Egert S, Frolich L, Gertz HJ, Kehl V, Wagenpfeil S, Werheid K. CORDIAL: cognitive rehabilitation and cognitive-behavioral treatment for early dementia in Alzheimer disease: a multicenter, randomized, controlled trial. Alzheimer Dis Assoc Disord. 2012 Jul-Sep;26(3):246-53. doi: 10.1097/WAD.0b013e318231e46e.