CBM in the Context of Exposure for Acrophobia

NCT05780203 | Completed

• 1 other identifier: 674
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acrophobia

Keywords

anxiety disorders; acrophobia; exposure; cognitive bias modification; interpretational processing biases

Outcome Measures

Primary Outcomes (1)

• Acrophobia-related interpretational processing biases as measured using the Encoding Recognition Task

  Acrophobia-related interpretational processing biases will be measured using a modified version of the Encoding Recognition Task (ERT, Salemink \& van den Hout, 2010). Bias scores of the Encoding Recognition Task can range from -4 to +4, with lower scores indicating a more negative interpretation bias. The primary outcome is change in bias score from baseline to post-training.

  baseline, post-training (~1 week post-baseline)

Secondary Outcomes (6)

• Acrophobia-related interpretational processing biases as measured using the Encoding Recognition Task

  baseline, pre-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)

• Heights Interpretation Questionnaire (HIQ)

  baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)

• Scrambled Sentences Task (SST)

  post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)

• Danger/ Anxiety Expectancy Scale (DES/AES)

  baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)

• Acrophobia Questionnaire (AQ)

  baseline, pre-training (1 day after exposure; ~1 week post-baseline), follow-up (~5 weeks post-baseline)

Other Outcomes (5)

• Levels of Progesterone and Estradiol

  pre-exposure (just before exposure; ~1 week post-baseline)

• Negative Effects Questionnaire (NEQ)

  follow-up (~5 weeks post-baseline)

• Feedback questionnaire

  follow-up (~5 weeks post-baseline)

Study Arms (2)

One session exposure treatment + active Cognitive Bias Modification training

EXPERIMENTAL

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.

Behavioral: One session exposure treatment; Behavioral: Active Cognitive Bias Modification training

One session exposure treatment + sham Cognitive Bias Modification training

SHAM COMPARATOR

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.

Behavioral: One session exposure treatment; Behavioral: Sham Cognitive Bias Modification training

Interventions

One session exposure treatment BEHAVIORAL

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

One session exposure treatment + active Cognitive Bias Modification training; One session exposure treatment + sham Cognitive Bias Modification training

Sham Cognitive Bias Modification training BEHAVIORAL

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

One session exposure treatment + sham Cognitive Bias Modification training

Active Cognitive Bias Modification training BEHAVIORAL

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

One session exposure treatment + active Cognitive Bias Modification training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• University Hospital, Essen: collaborator

Study Sites (1)

Mental Health and Research Center, Ruhr University of Bochum

Bochum, 44787, Germany

Location

Related Links

• Project on Open Science Framework

MeSH Terms

Conditions

Acrophobia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Marcella Woud, Dr.

  marcella.woud@rub.de

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 22, 2023
• Study Start: April 11, 2023
• Primary Completion: October 27, 2023
• Study Completion: December 15, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Supporting information will be made available on publication via a suitable repository such as the Open Science Framework, and will be made available to reviewers at the time of submission (or publically with a pre-print version of the manuscript).
• Access Criteria: Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.

Locations

DE (1)