CBM in the Context of Exposure for Acrophobia

NCT ID: NCT05780203

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The proposed study will apply a one-session exposure treatment combined with CBM training modifying interpretational processing biases versus a sham training in acrophobic individuals. The main aim is to advance our understanding of the mechanisms underlying exposure treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The present study will apply a one-session exposure treatment followed by a computerized interpretational training (CBM) or sham training in acrophobic individuals. By doing so, it aims to better understand the mechanisms underlying exposure, i.e., the role of cognitive change. Specifically, this study aims to enhance changes in disorder-relevant cognitive processing post-exposure, compared to a sham training. Further, we hope to improve both therapy outcomes and the generalization of therapeutic effects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acrophobia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

One session exposure treatment + active Cognitive Bias Modification training

The exposure treatment will be administered at the tower of the German Mining museum. The day after the exposure session, patients will complete the CBM training in the lab of the Mental Health and Research Center of Ruhr University Bochum.

Group Type EXPERIMENTAL

One session exposure treatment

Intervention Type BEHAVIORAL

One session exposure treatment during which patients will be confronted with a height-related situation.

Active Cognitive Bias Modification training

Intervention Type BEHAVIORAL

Active Cognitive Bias Modification training targeting height-related, interpretational processing biases.

One session exposure treatment + sham Cognitive Bias Modification training

The exposure treatment will be administered at the tower of the German Mining museum. The day after the exposure session, patients will complete the sham CBM training in the lab of the Mental Health and Research Center of Ruhr University Bochum.

Group Type SHAM_COMPARATOR

One session exposure treatment

Intervention Type BEHAVIORAL

One session exposure treatment during which patients will be confronted with a height-related situation.

Sham Cognitive Bias Modification training

Intervention Type BEHAVIORAL

Sham Cognitive Bias Modification training procedure matched in format to active training but adapted to not target height-related, interpretational processing biases.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

One session exposure treatment

One session exposure treatment during which patients will be confronted with a height-related situation.

Intervention Type BEHAVIORAL

Sham Cognitive Bias Modification training

Sham Cognitive Bias Modification training procedure matched in format to active training but adapted to not target height-related, interpretational processing biases.

Intervention Type BEHAVIORAL

Active Cognitive Bias Modification training

Active Cognitive Bias Modification training targeting height-related, interpretational processing biases.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Informed consent
2. Sufficient German language skills to complete the experimental tasks and questionnaires
3. Aged between 18 and 65 years
4. Current primary diagnosis of acrophobia as defined by DSM-5 (based on DIPS)
5. Lives within reasonable travelling distance of the research center

Exclusion Criteria

1. Currently in psychotherapeutic treatment
2. Impaired therapy capability (as judged by researcher/clinician)
3. Current diagnosis of substance use disorder (via DIPS)
4. Current or past diagnosis of psychotic disorder or bipolar disorder (via DIPS)
5. Acute suicidality (via DIPS)
6. Diagnosis of chronical physical or neurological diseases (self-reported by participant)
7. Personality Disorder (via DIPS or via clinical judgement)
8. Attention-deficit hyperactivity disorder (self-reported by participant or via DIPS)
9. Intellectual disability (self-reported by participant or via clinical judgment)
10. Women: pregnancy or breast feeding (self-reported by participant)
11. Intake of medication that could impede the effects of exposure therapy or CBM training (e.g., Lorazepam)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Essen

OTHER

Sponsor Role collaborator

Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Beray Macit

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marcella Woud, Dr.

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mental Health and Research Center, Ruhr University of Bochum

Bochum, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Related Links

Access external resources that provide additional context or updates about the study.

https://osf.io/m35jf/

Project on Open Science Framework

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

674

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Bias Modification for OCD
NCT03799419 COMPLETED NA
Quetiapine in Specific Phobia
NCT00872716 COMPLETED PHASE2