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Cognitive Behavioural Therapy for Persons With MCI or Mild Dementia

Primary Purpose

Alzheimers' Disease

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimers' Disease focused on measuring Alzheimers' disease, Cognitive behavioral therapy, Depression, Self-efficacy, Quality of Life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cognitive behavioural therapy

Control group

Arm 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 as usual at the participating memory clinics

Outcomes

Primary Outcome Measures

Number of participants reporting decrease in depression scores
Depression, measured by the Montegomery and Åsberg Depression Rating Scale (MADRS) (Åsberg et al., 1978), the Hospital Anxiety and Depression Scale (HAD) (Zigmond & Snaith, 1983) and the Cornell Scale for Depression in Dementia (Alexopoulos, Abrams, Young & Shamoian, 1988). In addition MADRS will be used to measure depression in the carers.

Secondary Outcome Measures

Number of participants reporting increased Self-efficacy
Self Efficacy, measured by Generalized Self-Efficacy Scale (Sherer et al., 1982) will be measured in the patients and carers.
Number of participants reporting increased Quality of Life
Quality of life, measured by the Quality of Life in Alzheimer's Disease (QOL-AD) (Logdson et al., 1999)will be measured in the patients and carers.
Number of participants reporting change in cognitive function
Neuropsychological tests, such as Mini Mental state examination (MMSE), Trial Making Test (TMTA and TKTB) and CERAD 10-word test, will be conducted. This test is widely used to evaluate the cognitive impairments required for the AD diagnoses.
Number of participating caregivers reporting decreased burden of care
Overall burden in the carers, measured by The Relatives' Stress Scale (RSS) (Greene, Smith, Gardiner & Timbury, 1982).

Full Information

First Posted
November 11, 2013
Last Updated
December 11, 2013
Sponsor
Oslo University Hospital
Collaborators
Sykehuset i Vestfold HF, Sykehuset Innlandet HF
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1. Study Identification

Unique Protocol Identification Number
NCT02013518
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
Collaborators
Sykehuset i Vestfold HF, Sykehuset Innlandet HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimers' Disease
Keywords
Alzheimers' disease, Cognitive behavioral therapy, Depression, Self-efficacy, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioural therapy
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Other
Arm Description
Treatment as usual at the participating memory clinics
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Number of participants reporting decrease in depression scores
Description
Depression, measured by the Montegomery and Åsberg Depression Rating Scale (MADRS) (Åsberg et al., 1978), the Hospital Anxiety and Depression Scale (HAD) (Zigmond & Snaith, 1983) and the Cornell Scale for Depression in Dementia (Alexopoulos, Abrams, Young & Shamoian, 1988). In addition MADRS will be used to measure depression in the carers.
Time Frame
Up to nine month
Secondary Outcome Measure Information:
Title
Number of participants reporting increased Self-efficacy
Description
Self Efficacy, measured by Generalized Self-Efficacy Scale (Sherer et al., 1982) will be measured in the patients and carers.
Time Frame
Up to 9 month
Title
Number of participants reporting increased Quality of Life
Description
Quality of life, measured by the Quality of Life in Alzheimer's Disease (QOL-AD) (Logdson et al., 1999)will be measured in the patients and carers.
Time Frame
Up to 9 month
Title
Number of participants reporting change in cognitive function
Description
Neuropsychological tests, such as Mini Mental state examination (MMSE), Trial Making Test (TMTA and TKTB) and CERAD 10-word test, will be conducted. This test is widely used to evaluate the cognitive impairments required for the AD diagnoses.
Time Frame
Up to 9 month
Title
Number of participating caregivers reporting decreased burden of care
Description
Overall burden in the carers, measured by The Relatives' Stress Scale (RSS) (Greene, Smith, Gardiner & Timbury, 1982).
Time Frame
3 month and 9 month
Other Pre-specified Outcome Measures:
Title
Number of participants reporting satisfaction with the intervention programme
Description
Client Satisfaction Scale (CSQ-8) (Larsen, Attkisson & Ngyen, 1979) (patient rated).
Time Frame
Up to 9 month
Title
Number of participants with a decreased number and severity of neuropsychiatric symptoms
Description
The Neuropsychiatric Inventory Questionnaire (NPI-Q) (Cummings et al., 1997) (proxy rated)
Time Frame
Up to 9 month
Title
Use and costs of health care services
Description
The Resource Utilisation in Dementia (RUD Lite) (Wimo, 1998) (patient rated), and client satisfaction measured by
Time Frame
Up to 9 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingun D Ulstein, MD PhD
Organizational Affiliation
Old Age Psychiatric Department, Oslo Univeristy Hospital, slottsberget 35, 1385 Asker, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
21986341
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.
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Cognitive Behavioural Therapy for Persons With MCI or Mild Dementia

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