Cognitive Behavioural Therapy for Persons With MCI or Mild Dementia

Cognitive Behavioural Therapy for Persons With Mild Cognitive Impairment or Dementia in the Early Stages

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimers' Disease
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavioural therapy; 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.	Behavioral: Cognitive Behavioural Therapy; 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.
Other: Control group; Treatment as usual at the participating memory clinics	Behavioral: Cognitive Behavioural Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to nine month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 9 month
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.	Up to 9 month
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.	Up to 9 month
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).	3 month and 9 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants reporting satisfaction with the intervention programme	Client Satisfaction Scale (CSQ-8) (Larsen, Attkisson & Ngyen, 1979) (patient rated).	Up to 9 month
Number of participants with a decreased number and severity of neuropsychiatric symptoms	The Neuropsychiatric Inventory Questionnaire (NPI-Q) (Cummings et al., 1997) (proxy rated)	Up to 9 month
Use and costs of health care services	The Resource Utilisation in Dementia (RUD Lite) (Wimo, 1998) (patient rated), and client satisfaction measured by	Up to 9 month

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Sykehuset Innlandet HF; Sykehuset i Vestfold HF
• Investigators: Study Chair: Ingun D Ulstein, MD PhD, Old Age Psychiatric Department, Oslo Univeristy Hospital, slottsberget 35, 1385 Asker, Norway

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Cognitive behavioral therapy; Self-efficacy; Alzheimers' disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 2012/1943; 12345 (Danish Center for Healthcare Improvements)