Clinical trial NCT05780203: CBM in the Context of Exposure for Acrophobia
Official title: The Effects of Exposure in the Context of Anxious Thinking Styles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acrophobia
Keywords: anxiety disorders
acrophobia
exposure
cognitive bias modification
interpretational processing biases
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: University Hospital, Essen
First posted: 2023-03-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acrophobia-related interpretational processing biases as measured using the Encoding Recognition Task
timeFrame: baseline, post-training (~1 week post-baseline)
Secondary outcomes:
measure: Acrophobia-related interpretational processing biases as measured using the Encoding Recognition Task
timeFrame: baseline, pre-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
measure: Heights Interpretation Questionnaire (HIQ)
timeFrame: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
measure: Scrambled Sentences Task (SST)
timeFrame: post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
measure: Danger/ Anxiety Expectancy Scale (DES/AES)
timeFrame: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
measure: Acrophobia Questionnaire (AQ)
timeFrame: baseline, pre-training (1 day after exposure; ~1 week post-baseline), follow-up (~5 weeks post-baseline)
measure: Behavioral Approach Task (BAT)
timeFrame: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Other outcomes:
measure: Levels of Progesterone and Estradiol
timeFrame: pre-exposure (just before exposure; ~1 week post-baseline)
measure: Negative Effects Questionnaire (NEQ)
timeFrame: follow-up (~5 weeks post-baseline)
measure: Feedback questionnaire
timeFrame: follow-up (~5 weeks post-baseline)
measure: Depression Anxiety Stress Scale-21 (DASS-21)
timeFrame: baseline
measure: High Place Phenomenon Index (HPPI)
timeFrame: baseline
Locations:
city: Bochum
country: Germany
facility: Mental Health and Research Center, Ruhr University of Bochum
Study officials:
affiliation: marcella.woud@rub.de
name: Marcella Woud, Dr.
role: PRINCIPAL_INVESTIGATOR
References: