Geriatric Patients in a Pre-rehabilitative TreatmentNCT07137676
Monitoring and Cognitive Appraisal: The Etiology of Psychological Disorders and The Divergence Between Behavioural and Self-reported Data
A study testing AX-CPT in people with Geriatric Patients in a Pre-rehabilitative Treatment and Mild Cognitive Impairment (MCI), run by St. Franziskus Hospital at 1 site in Germany.
Trial summary
The study investigates the etiology of psychogical disorders from a neuropsychological perspective based on monitoring and cognitive appraisal. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Patients in a Pre-rehabilitative Treatment, Mild Cognitive Impairment (MCI)
- What is being tested?
- AX-CPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 16 Dec 2023to 9 Mar 2025
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- geriatric patient of the St. Franziskus-Hospital, Germany.
Who cannot join
- severe dementia
- delirium
- psychotic disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
St. Franziskus-Hospital Winterberg
Winterberg, North Rhine-Westphalia, 59955
About this study
The study investigates the etiology of psychogical disorders from a neuropsychological perspective based on monitoring and cognitive appraisal.
- Being tested
- AX-CPT, No Interventions
- Keywords
- monitoring, cognitive appraisal
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AX-CPTBehavioural
administration of the AX-CPT
No InterventionsOther
Control group with no intervention treatment
| Study group | Role | What they receive |
|---|---|---|
| AX-CPT Treatment | Experimental | Treatment with the AX-CPT Receives: Behavioral: AX-CPT |
| Control Group | Other | AX-CPT is merely administrated as pre-and posttest measure. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
AX-CPT (AX-Continuous Performance Test)
The AX-CPT assesses cognitive control through error rates and reaction times. Range: Error rate: 0-100%; Reaction time: measured in milliseconds Interpretation: Lower error rates and faster reaction times indicate better cognitive control performance.
Measured: from beginning (day 2) of the hospitalization to the end (day 14) of the biweekly pre-rehabilitative treatment.
CCFQ (Cognitive Control and Flexibility Questionnaire)
The CCFQ measures self-reported cognitive flexibility and control.
Scale title: Cognitive Control and Flexibility Questionnaire Range: 1-7 per item Interpretation: Higher scores indicate greater cognitive flexibility and control.
Measured: Day 1 (pretest) and Day 14 (posttest)
BSI-18 (Brief Symptom Inventory - 18)
T he BSI-18 assesses psychological symptom severity in terms of depression, anxiety, and somatization.T
Scale title: Brief Symptom Inventory - 18 Range: 0-4 per item Interpretation: Higher scores indicate greater symptom severity.
Measured: Day 1 (pretest) and Day 14 (posttest)
MHC-SF (Mental Health Continuum - Short Form)
Measures emotional, psychological, and social well-being. Range: 1-6 per item Interpretation: Higher scores indicate better mental health.
Measured: Day 1 (pretest) and Day 14 (posttest)
Secondary outcomes (2)
General Self-Efficacy assessed via General Self-Efficacy Scale (SWE)
Evaluation of perceived self-efficacy across various life domains. Range: 1-4 per item Interpretation: Higher scores indicate greater self-efficacy.
Measured: Day 1 (pretest) and Day 14 (posttest)
Treatment Beliefs assessed via Palermo Questionnaire
Beliefs and expectations regarding treatment effectiveness. Range: 1-5 per item Interpretation: Higher scores indicate stronger and more positive treatment beliefs.
Measured: Day 1 (pretest) and Day 14 (posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start16 Dec 2023
- Primary completion9 Mar 2025
- Study completion9 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric Patients in a Pre-rehabilitative TreatmentStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Alker, St. Franziskus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137676
- Sponsor's protocol ID
- file reference 2024-01k
- Other IDs
- ethics comittee
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data contains patient-relevant information that is protected under the European General Data Protection Regulation act.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Cognitive Appraisal: The Etiology of Psychological Disorders and The Divergence Between Behavioural and Self-reported Data
- ClinicalTrials.gov ID
- NCT07137676
- Acronym / sponsor ID
- file reference 2024-01k
- Keywords
- monitoring, cognitive appraisal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Study start
- 16 Dec 2023 (actual)
- Primary completion
- 9 Mar 2025 (actual)
- Study completion
- 9 Mar 2025 (actual)
- First posted
- 22 Aug 2025 (actual)
- 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.
The study investigates the etiology of psychogical disorders from a neuropsychological perspective based on monitoring and cognitive appraisal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AX-CPT Treatment | Experimental | Behavioral: AX-CPTTreatment with the AX-CPT |
| Control Group | Other | Other: No InterventionsAX-CPT is merely administrated as pre-and posttest measure. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- geriatric patient of the St. Franziskus-Hospital, Germany.
Key exclusion criteria (3 listed)
- severe dementia
- delirium
- psychotic disorders
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 |
|---|---|---|
| AX-CPTadministration of the AX-CPT | Behavioural | AX-CPT Treatment |
| No InterventionsControl group with no intervention treatment | Other | Control Group |
Primary outcome
AX-CPT (AX-Continuous Performance Test)
Time frame: from beginning (day 2) of the hospitalization to the end (day 14) of the biweekly pre-rehabilitative treatment.
The AX-CPT assesses cognitive control through error rates and reaction times. Range: Error rate: 0-100%; Reaction time: measured in milliseconds Interpretation: Lower error rates and faster reaction times indicate better cognitive control performance.
CCFQ (Cognitive Control and Flexibility Questionnaire)
Time frame: Day 1 (pretest) and Day 14 (posttest)
The CCFQ measures self-reported cognitive flexibility and control. Scale title: Cognitive Control and Flexibility Questionnaire Range: 1-7 per item Interpretation: Higher scores indicate greater cognitive flexibility and control.
BSI-18 (Brief Symptom Inventory - 18)
Time frame: Day 1 (pretest) and Day 14 (posttest)
T he BSI-18 assesses psychological symptom severity in terms of depression, anxiety, and somatization.T Scale title: Brief Symptom Inventory - 18 Range: 0-4 per item Interpretation: Higher scores indicate greater symptom severity.
MHC-SF (Mental Health Continuum - Short Form)
Time frame: Day 1 (pretest) and Day 14 (posttest)
Measures emotional, psychological, and social well-being. Range: 1-6 per item Interpretation: Higher scores indicate better mental health.
2 secondary outcomes
General Self-Efficacy assessed via General Self-Efficacy Scale (SWE)
Time frame: Day 1 (pretest) and Day 14 (posttest)
Treatment Beliefs assessed via Palermo Questionnaire
Time frame: Day 1 (pretest) and Day 14 (posttest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No. the data contains patient-relevant information that is protected under the European General Data Protection Regulation act.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AX-CPT in people with Geriatric Patients in a Pre-rehabilitative Treatment and Mild Cognitive Impairment (MCI), run by St. Franziskus Hospital at 1 site in Germany.
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 1 inclusion and 3 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 22 Aug 2025. 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 Germany. 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?
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?
AX-CPT (AX-Continuous Performance Test) (time frame: from beginning (day 2) of the hospitalization to the end (day 14) of the biweekly pre-rehabilitative treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.