Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers

NCT01273272 | Completed Phase 2

• 1 other identifier: 10-130034/1a
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.

Conditions

Alzheimer Disease

Keywords

Cognitive Behavior Therapy; Early dementia, Alzheimer type

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Geriatric Depression Scale (GDS)

  Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

Secondary Outcomes (10)

• Change from baseline in Neuropsychiatric Inventory (NPI)

  Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

• Change from baseline in Bayer-Activities of Daily Living (B-ADL)

  Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

• Change from baseline in Stress Coping Inventory (SCI)

  Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

• Change from baseline in Apathy Evaluation Scale (AES)

  Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

• Caregiver: Change from baseline in Center for Epidemiologic Studies Depression Scale (CES-D)

  Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

Study Arms (2)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

Comprehensive, CBT-based, multi-component treatment. Comprehensive CBT intervention in addition to standard treatment

Behavioral: Comprehensive, CBT-based, multi-component treatment

Treatment as usual (TAU)

ACTIVE COMPARATOR

Standard Treatment (medical and psychosocial)

Behavioral: Treatment as usual

Interventions

Comprehensive, CBT-based, multi-component treatment BEHAVIORAL

It includes eight modules: diagnosis and goal setting; psychoeducation; engagement in pleasant activities; cognitive restructuring; live review; training caregiver in behavior man-agement techniques; interventions for the caregiver; and couples counselling. It consists of 20 weekly sessions (plus appr. 5 single session with caregiver).

Also known as: Psychosocial intervention

Cognitive Behavioral Therapy (CBT)

Treatment as usual BEHAVIORAL

Each patient/caregiver must receive at least three out of six interventions: (1) psychoeducation on dementia and treatment of dementia (oral and written); (2) appropriate medical treatment; (3) social counseling by specialized staff; (4) memory training in group setting; (5) self-help group for the patient; (6) self-help group for the caregiver.

Also known as: Standard treatment

Treatment as usual (TAU)

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have to meet NINCDS-ADRDA criteria for probable or possible AD (McKhann et al., 1984). Mixed Alzheimer and Vascular dementia cases will also be included.
• Only AD cases with a mild dementia severity will be included, determined by the Clinical Dementia Rating (CDR) scale (i.e. scores of 0.5 or 1, Morris, 1993) and by the Mini Mental State Examination (MMSE) (i.e. scores of 20 or more, Folstein, Folstein, \& McHugh, 1975).
• The patient must suffer under any non-cognitive symptom that motivates him to accept psy-chotherapeutic help.
• A caregiver must be available to take part in most of the therapy sessions.

You may not qualify if:

• concomitant alcohol or drug addiction and a history of a malignant disease, severe organ failure, metabolic or hematologic disorders, neurosurgery or neurological condition such as Parkinson's disease, epilepsy, postencephalitic and postconcussional syndrome

Sponsors & Collaborators

• University of Zurich: lead
• Psychiatric University Hospital, Zurich: collaborator

Study Sites (1)

Psychiatric University Hospital, Clinic for Geriatric Medicine

Zurich, 8032, Switzerland

Location

Related Publications (4)

• Forstmeier S, Maercker A. Problems of aging. Psychotherapy in older age [German]. Göttingen, Germany: Hogrefe. 2008.

  BACKGROUND

• Forstmeier S, Maercker A. Psychotherapie im Alter. Psychotherapeutenjournal 4: 340-352, 2007

  BACKGROUND

• Forstmeier S, Maercker A, Savaskan E, Roth T. Cognitive behavioural treatment for mild Alzheimer's patients and their caregivers (CBTAC): study protocol for a randomized controlled trial. Trials. 2015 Nov 17;16:526. doi: 10.1186/s13063-015-1043-0.

  PMID: 26576633 BACKGROUND

• Forstmeier S, Maercker A, Bohli L, Savaskan E, Roth T. Cognitive behavioural treatment for mild Alzheimer's patients and their caregivers (CBTAC): results of a randomised controlled trial. Aging Ment Health. 2025 Feb;29(2):359-368. doi: 10.1080/13607863.2024.2393748. Epub 2024 Aug 20.

  PMID: 39164933 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Psychosocial Intervention; Therapeutics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Simon Forstmeier, Ph.D.

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Andreas Maercker, M.D.,Ph.D.

  University of Zurich

  STUDY CHAIR

• Egemen Savaskan, M.D.

  Psychiatric University Hospital, Zurich

  STUDY CHAIR

• Tanja Roth, Ph.D.

  Psychiatric University Hospital, Zurich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 10, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

CH (1)