Cognitive Behavioural Therapy for Persons With MCI or Mild Dementia

University of Oslo (UIO)

Status: Unknown

Conditions: Alzheimers' Disease

Treatments: Behavioral: Cognitive Behavioural Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02013518

2012/1943

12345

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Cognitive behavioural therapy

Experimental group

Description:

11 standardised weekly one-hour sessions/6 modules: Module one - introduction to the programme. Module two - pleasant activities to improve mood and depressive symptoms. Module three - the use of external memory aids to help the patients to maintain independence in their daily life. Module four - establishing behavioural routines to reduce demands on memory. Module five - stimulates patients to actively engage in reminiscence and memories to improve mood and well-being. Module six - review of the programme and individual treatment goals.

Treatment:

Behavioral: Cognitive Behavioural Therapy

Control group

Other group

Description:

Treatment as usual at the participating memory clinics

Treatment:

Behavioral: Cognitive Behavioural Therapy