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Alzheimer DiseasePhase 2CBTACNCT01273272

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

A Phase 2 study testing Comprehensive, CBT-based, multi-component treatment and Treatment as usual in people with Alzheimer Disease, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 95 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Comprehensive, CBT-based, multi-component treatment and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
Feb 2011to Sep 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Psychiatric University Hospital, Clinic for Geriatric Medicine

    Zurich, 8032

Other trials in Switzerland

About this study

Official title: Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial

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.

Read the detailed description

Mild Alzheimer's dementia (AD) cases are with 15 millions worldwide the largest fraction of all AD cases. Most patients are cared for by their family at home. Neuropsychiatric symptoms are very common in AD, even as early as in mild AD: About 90% of all mild AD cases experience neuropsychiatric symptoms, most frequently depression, anxiety, and irritability. These symptoms are associated with greater morbidity, reduced quality of life for the patient, increased burden and depression for the caregiver, higher costs of care, and nursing home placement. Thus, interventions aimed at treating these symptoms could have a tremendous effect on pa-tients, caregivers, and society.

This study is a randomized, controlled trial (RCT) evaluating a comprehensive CBT-based, multi-component treatment programme consisting of eight modules (diagnosis and goal-setting; psycho-education; engagement in pleasant activities; cognitive restructuring; life review; training caregiver in behavior management techniques; interventions for the caregiver; couples counseling) and 20 sessions.

This trial aims at significantly reducing depressive and other neuropsychiatric symptoms in the AD patients, and secondary in reducing burden and depressive symptoms of the caregivers. Patients with AD alone or mixed AD and vascular dementia that are in the mild stage and suffer under any neuropsychiatric symptom will be included. The patients and their caregiver will be randomized to either the CBT-based intervention or to the control condition that receives treatment as usual (TAU).

Being tested
Comprehensive, CBT-based, multi-component treatment, Treatment as usual
Keywords
Cognitive Behavior Therapy, Early dementia, Alzheimer type
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive, CBT-based, multi-component treatmentBehavioural

    Also called Psychosocial intervention

    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).

  • Treatment as usualBehavioural

    Also called Standard treatment

    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.

Study groups in NCT01273272
Study groupRoleWhat they receive
Cognitive Behavioral Therapy (CBT)ExperimentalComprehensive, CBT-based, multi-component treatment. Comprehensive CBT intervention in addition to standard treatment
Receives: Behavioral: Comprehensive, CBT-based, multi-component treatment
Treatment as usual (TAU)Active comparatorStandard Treatment (medical and psychosocial)
Receives: Behavioral: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Geriatric Depression Scale (GDS)

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

Secondary outcomes (10)

  1. Change from baseline in Neuropsychiatric Inventory (NPI)

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

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

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

  3. Change from baseline in Stress Coping Inventory (SCI)

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

  4. Change from baseline in Apathy Evaluation Scale (AES)

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

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

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

  6. Caregiver: Change from baseline in Trait scale of the State Trait Anxiety Inventory (STAI)

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

  7. Caregiver: Change from baseline in Anger-in and anger-out scales of the State Trait Anger Expression Inventory (STAXI)

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

  8. Caregiver: Change from baseline in Short-Form Health Survey (SF-12)

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

  9. Caregiver: Change from baseline in Zarit Burden Interview (ZBI)

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

  10. Caregiver: Change from baseline in Stress Coping Inventory (SCI)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01273272
Sponsor's protocol ID
10-130034/1a
Acronym
CBTAC
Status last verified
Nov 2017
First submitted
3 Jan 2011
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

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

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

  • 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.

    PubMed 26576633

  • 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.

    PubMed 39164933

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Comprehensive, CBT-based, multi-component treatment and Treatment as usual in people with Alzheimer Disease, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Geriatric Depression Scale (GDS) (time frame: Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01273272, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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