NCT07137676

Brief Summary

The study investigates the etiology of psychogical disorders from a neuropsychological perspective based on monitoring and cognitive appraisal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

July 25, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

monitoringcognitive appraisal

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Day 1 (pretest) and Day 14 (posttest)

Secondary Outcomes (2)

  • General Self-Efficacy assessed via General Self-Efficacy Scale (SWE)

    Day 1 (pretest) and Day 14 (posttest)

  • Treatment Beliefs assessed via Palermo Questionnaire

    Day 1 (pretest) and Day 14 (posttest)

Study Arms (2)

AX-CPT Treatment

EXPERIMENTAL

Treatment with the AX-CPT

Behavioral: AX-CPT

Control Group

OTHER

AX-CPT is merely administrated as pre-and posttest measure.

Other: No Interventions

Interventions

AX-CPTBEHAVIORAL

administration of the AX-CPT

AX-CPT Treatment

Control group with no intervention treatment

Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • geriatric patient of the St. Franziskus-Hospital, Germany.

You may not qualify if:

  • severe dementia
  • delirium
  • psychotic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Franziskus-Hospital Winterberg

Winterberg, North Rhine-Westphalia, 59955, Germany

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Clinical Neuropsychologist (Winterberg, Germany)

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 22, 2025

Study Start

December 16, 2023

Primary Completion

March 9, 2025

Study Completion

March 9, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

the data contains patient-relevant information that is protected under the European General Data Protection Regulation act.

Locations