Alzheimers' DiseaseNCT02013518
Cognitive Behavioural Therapy for Persons With MCI or Mild Dementia
A study testing Cognitive Behavioural Therapy in people with Alzheimers' Disease, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimers' Disease
- What is being tested?
- Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2013to Dec 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Cognitive Behavioural Therapy
- Keywords
- Alzheimers' disease, Cognitive behavioral therapy, Depression, Self-efficacy, Quality of Life
- Medical subject headings
- Alzheimer Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioural Therapy |
| Control group | Other | Treatment as usual at the participating memory clinics Receives: Behavioral: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to nine month
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 3 month and 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimers' DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset i Vestfold HF, Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Ingun D Ulstein, MD PhD, Study chair, Old Age Psychiatric Department, Oslo Univeristy Hospital, slottsberget 35, 1385 Asker, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013518
- Sponsor's protocol ID
- 2012/1943
- Other IDs
- 12345
- Status last verified
- Dec 2013
- First submitted
- 11 Nov 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21986341
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Persons With Mild Cognitive Impairment or Dementia in the Early Stages
- ClinicalTrials.gov ID
- NCT02013518
- Acronym / sponsor ID
- 2012/1943
- Conditions
- Alzheimers' Disease
- Keywords
- Alzheimers' disease, Cognitive behavioral therapy, Depression, Self-efficacy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sykehuset i Vestfold HF, Sykehuset Innlandet HF
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioural therapy | Experimental | Behavioral: Cognitive Behavioural Therapy11 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. |
| Control group | Other | Behavioral: Cognitive Behavioural TherapyTreatment as usual at the participating memory clinics |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy11 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. | Behavioural | Cognitive behavioural therapy, Control group |
Primary outcome
Number of participants reporting decrease in depression scores
Time frame: Up to nine month
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.
4 secondary outcomes
Number of participants reporting increased Self-efficacy
Time frame: Up to 9 month
Number of participants reporting increased Quality of Life
Time frame: Up to 9 month
Number of participants reporting change in cognitive function
Time frame: Up to 9 month
Number of participating caregivers reporting decreased burden of care
Time frame: 3 month and 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Background: PubMed 21986341Kurz 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingun D Ulstein, MD PhD study chair
Old Age Psychiatric Department, Oslo Univeristy Hospital, slottsberget 35, 1385 Asker, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Alzheimers' Disease, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2013. 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 Norway. 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.
Are results available for this study?
Results are not available in the source record.
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?
Number of participants reporting decrease in depression scores (time frame: Up to nine month). 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 NCT02013518, which also lists 1 linked publication.
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 17 Dec 2013.