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Completed

NCT Number: NCT05780203

CBM in the Context of Exposure for Acrophobia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health and Research Center, Ruhr University of Bochum

Bochum, 44787, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

One session exposure treatment

Behavioral

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

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.

Active Cognitive Bias Modification training

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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.

  2. Heights Interpretation Questionnaire (HIQ)

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

    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.

  3. Scrambled Sentences Task (SST)

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

    Modified version of the Scrambled Sentences Task (Wenzlaff & Bates, 1998), including 20 height-related items that can be unscrambled into positive or negative statements.

  4. Danger/ Anxiety Expectancy Scale (DES/AES)

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

    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.

  5. Acrophobia Questionnaire (AQ)

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

    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.

  6. Behavioral Approach Task (BAT)

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

    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.

Other outcomes

  1. Levels of Progesterone and Estradiol

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

    Via salivary samples, patients' endogenous levels of estradiol and progesterone will be assessed.

  2. Negative Effects Questionnaire (NEQ)

    Time frame: follow-up (~5 weeks post-baseline)

    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.

  3. Feedback questionnaire

    Time frame: follow-up (~5 weeks post-baseline)

    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.

  4. Depression Anxiety Stress Scale-21 (DASS-21)

    Time frame: baseline

    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.

  5. High Place Phenomenon Index (HPPI)

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Collaborators

  • University Hospital, Essen

Registry information

Official study title

The Effects of Exposure in the Context of Anxious Thinking Styles

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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