CBM in the Context of Exposure for Acrophobia

Acrophobia Clinical Trial

Official title:

The Effects of Exposure in the Context of Anxious Thinking Styles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05780203
• Other study ID #: 674
• Status: Completed
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: April 2024
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 15, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acrophobia

Intervention

Behavioral:
• One session exposure treatment
One session exposure treatment during which patients will be confronted with a height-related situation.
• 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.
• Active Cognitive Bias Modification training
Active Cognitive Bias Modification training targeting height-related, interpretational processing biases.

Locations

Country	Name	City	State
Germany	Mental Health and Research Center, Ruhr University of Bochum	Bochum

Sponsors (2)

Lead Sponsor	Collaborator
Ruhr University of Bochum	University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Levels of Progesterone and Estradiol	Via salivary samples, patients' endogenous levels of estradiol and progesterone will be assessed.	pre-exposure (just before exposure; ~1 week post-baseline)
Other	Negative Effects Questionnaire (NEQ)	Adverse events during the study will be assessed with an adapted version of the Negative Effects Questionnaire, which is a 20-item questionnaire designed to assess potential negative effects of psychological interventions (Rozental et al., 2019), in this context also including the CBM training. Scores can range from 0 to 80, with higher scores indicating more negative effects.	follow-up (~5 weeks post-baseline)
Other	Feedback questionnaire	We will use a feedback questionnaire containing both rating scales and open questions to assess patients' feedback about the study and interventions completed.; Scores can range from 21 to 189, with higher scores indicating a more positive feedback.	follow-up (~5 weeks post-baseline)
Other	Depression Anxiety Stress Scale-21 (DASS-21)	Symptoms of depression, stress and anxiety will be assessed using the Depression Anxiety Stress Scale-21 (Lovibond & Lovibond, 1995) which consists of seven symptom-related items per subscale. Participants are asked to rate the strength of each symptom in the past week. Scores can range from 0 to 63, with overall higher values indicate more severe symptoms.	baseline
Other	High Place Phenomenon Index (HPPI)	We will use the High Place Phenomenon Index (HPPI; Hames et al., 2012; German version: Teismann et al., 2020) to assess how often participants experienced the "high place phenomenon". This phenomenon involves the sudden urge to jump down when being in a high place and thus may be relevant in the context of acrophobia. The index consists of three items about three different height-related situations, and patients have to indicate whether they experienced the high place phenomenon in each situation using a 6-point Likert scale. Scores can range from 0 to 15, with higher scores indicating more frequent experiences of the high place phenomenon.	baseline
Primary	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	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.	baseline, pre-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Secondary	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.	baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Secondary	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.	post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Secondary	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.	baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)
Secondary	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.	baseline, pre-training (1 day after exposure; ~1 week post-baseline), follow-up (~5 weeks post-baseline)
Secondary	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.	baseline, post-training (~1 week post-baseline), follow-up (~5 weeks post-baseline)

External Links

•   Project on Open Science Framework