Cognitive Behavioural Therapy for Persons With MCI or Mild Dementia

NCT02013518 | Unknown

• 2 other identifiers: 2012/194312345
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimers' Disease

Keywords

Alzheimers' disease; Cognitive behavioral therapy; Depression; Self-efficacy; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participants reporting increased Self-efficacy

  Up to 9 month

• Number of participants reporting increased Quality of Life

  Up to 9 month

• Number of participants reporting change in cognitive function

  Up to 9 month

• Number of participating caregivers reporting decreased burden of care

  3 month and 9 month

Other Outcomes (3)

• Number of participants reporting satisfaction with the intervention programme

  Up to 9 month

• Number of participants with a decreased number and severity of neuropsychiatric symptoms

  Up to 9 month

• Use and costs of health care services

  Up to 9 month

Study Arms (2)

Cognitive behavioural therapy

EXPERIMENTAL

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

Control group

OTHER

Treatment as usual at the participating memory clinics

Behavioral: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

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.

Cognitive behavioural therapy; Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sykehuset i Vestfold HF: collaborator
• Sykehuset Innlandet HF: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 21986341 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ingun D Ulstein, MD PhD

  Old Age Psychiatric Department, Oslo Univeristy Hospital, slottsberget 35, 1385 Asker, Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: December 17, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

NO (1)