AcrophobiaNCT05780203
CBM in the Context of Exposure for Acrophobia
A study testing One session exposure treatment and Active Cognitive Bias Modification training in people with Acrophobia, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acrophobia
- What is being tested?
- One session exposure treatment and Active Cognitive Bias Modification training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 11 Apr 2023to 15 Dec 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Mental Health and Research Center, Ruhr University of Bochum
Bochum, 44787
About this study
Official title: The Effects of Exposure in the Context of Anxious Thinking Styles
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.
Read the 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.
- Conditions
- Acrophobia
- Being tested
- One session exposure treatment, Sham Cognitive Bias Modification training, Active Cognitive Bias Modification training
- Keywords
- anxiety disorders, acrophobia, exposure, cognitive bias modification, interpretational processing biases
- Medical subject headings
- Acrophobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One session exposure treatmentBehavioural
One session exposure treatment during which patients will be confronted with a height-related situation.
Sham Cognitive Bias Modification trainingBehavioural
Sham Cognitive Bias Modification training procedure matched in format to active training but adapted to not target height-related, interpretational processing biases.
Active Cognitive Bias Modification trainingBehavioural
Active Cognitive Bias Modification training targeting height-related, interpretational processing biases.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: One session exposure treatment; Behavioral: Sham Cognitive Bias Modification training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, post-training (~1 week post-baseline)
Secondary outcomes (6)
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 indicating a more negative interpretation bias.
Measured: baseline, pre-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Heights Interpretation Questionnaire (HIQ)
The Heights Interpretation Questionnaire (HIQ; Steinman \& Teachman, 2011) asks participants to rate the likelihood of eight negative interpretations for two height-related, ambiguous scenarios. Scores can range from 16 to 80, with higher scores indicating a worse outcome.
Measured: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Scrambled Sentences Task (SST)
Modified version of the Scrambled Sentences Task (Wenzlaff \& Bates, 1998), including 20 height-related items that can be unscrambled into positive or negative statements.
Measured: post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Danger/ Anxiety Expectancy Scale (DES/AES)
The Danger/ Anxiety Expectancy Scale (DES/AES; Gursky \& Reiss, 1987) asks participants to rate the likelihood of potential harmful events passing through their mind and the likelihood to experience anxiety symptoms if confronted with heights. Scores can range from 15 to 75, with higher scores indicating a worse outcome.
Measured: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Acrophobia Questionnaire (AQ)
The Acrophobia Questionnaire (AQ; Cohen, 1977) asks participants to rate their anxiety and avoidance behavior for 20 common height-related situations. Scores can range from 0 to 160, with higher scores indicating a worse outcome.
Measured: baseline, pre-training (1 day after exposure; ~1 week post-baseline), follow-up (~5 weeks post-baseline)
Behavioral Approach Task (BAT)
With the Behavioral Approach Task (BAT), participants' behavioral approach tendencies to height-relevant situations will be assessed by instructing participants to go as high as possible at the emergency staircase at the therapy center and asking participants to rate their subjective fear with the Subjective Units of Distress Scale (SUDS; Wolpe 1973). Scores can range from 0 to 100, with higher scores indicating greater fear.
Measured: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start11 Apr 2023
- Primary completion27 Oct 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcrophobiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Essen
- Responsible party
- Principal investigator, Beray Macit, Ruhr University of Bochum
- Investigators
- Marcella Woud, Dr., Principal investigator, marcella.woud@rub.de
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780203
- Sponsor's protocol ID
- 674
- Status last verified
- Apr 2024
- First submitted
- 8 Mar 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data 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).
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exposure in the Context of Anxious Thinking Styles
- ClinicalTrials.gov ID
- NCT05780203
- Acronym / sponsor ID
- 674
- Conditions
- Acrophobia
- Keywords
- anxiety disorders, acrophobia, exposure, cognitive bias modification, interpretational processing biases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- University Hospital, Essen
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 22 Mar 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One session exposure treatment + active Cognitive Bias Modification training | Experimental | Behavioral: One session exposure treatment, Behavioral: Active Cognitive Bias Modification trainingThe 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. |
| One session exposure treatment + sham Cognitive Bias Modification training | Sham comparator | Behavioral: One session exposure treatment, Behavioral: Sham Cognitive Bias Modification trainingThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
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 |
|---|---|---|
| One session exposure treatmentOne session exposure treatment during which patients will be confronted with a height-related situation. | Behavioural | One session exposure treatment + active Cognitive Bias Modification training, One session exposure treatment + sham Cognitive Bias Modification training |
| Sham Cognitive Bias Modification trainingSham Cognitive Bias Modification training procedure matched in format to active training but adapted to not target height-related, interpretational processing biases. | Behavioural | One session exposure treatment + sham Cognitive Bias Modification training |
| Active Cognitive Bias Modification trainingActive Cognitive Bias Modification training targeting height-related, interpretational processing biases. | Behavioural | One session exposure treatment + active Cognitive Bias Modification training |
Primary outcome
Acrophobia-related interpretational processing biases as measured using the Encoding Recognition Task
Time frame: baseline, post-training (~1 week post-baseline)
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.
6 secondary outcomes
Acrophobia-related interpretational processing biases as measured using the Encoding Recognition Task
Time frame: baseline, pre-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Heights Interpretation Questionnaire (HIQ)
Time frame: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Scrambled Sentences Task (SST)
Time frame: post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Danger/ Anxiety Expectancy Scale (DES/AES)
Time frame: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Acrophobia Questionnaire (AQ)
Time frame: baseline, pre-training (1 day after exposure; ~1 week post-baseline), follow-up (~5 weeks post-baseline)
Behavioral Approach Task (BAT)
Time frame: baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
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 23 Apr 2024.
- Project on Open Science FrameworkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised data 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).
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.
Marcella Woud, Dr. principal investigator
marcella.woud@rub.de
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One session exposure treatment and Active Cognitive Bias Modification training in people with Acrophobia, run by Ruhr University of Bochum 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 5 inclusion and 11 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 23 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
Acrophobia-related interpretational processing biases as measured using the Encoding Recognition Task (time frame: baseline, post-training (~1 week post-baseline)). 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 23 Apr 2024.