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Completed

NCT Number: NCT03105024

Self-efficacy Enhancement and Exposure Therapy

Self-efficacy refers to the perceived belief to cope effectively, by personal efforts, with challenging situations and problems (Bandura, 1977). Basic research has shown that increases in perceived self-efficacy can enhance the extinction of fear (Zlomuzica et al., 2015). This study is aimed at translating these findings into a useful clinical application to augment exposure-based treatment outcome.

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Key information

Conditions

Specific Phobia Phobia, Specific

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Research and Treatment Center

Bochum, North Rhine-Westphalia, 44787, Germany

About this study

In this study, the effects of self-efficacy enhancement on treatment outcome in patients with height phobia will be investigated.

Participants will be randomly assigned to one of the following conditions: i) virtual reality exposure + self-efficacy enhancement; ii) virtual reality exposure + control intervention; iii) virtual reality exposure only. The amount of exposure is identical across groups (i.e. maximum of 1 hour of exposure). The self-efficacy and the control intervention involve the retrieval of the exposure session with or without a focus on personal mastery experiences/achievements, respectively.

Treatment-induced changes as well as the effects of self-efficacy enhancement will be measured on the subjective level (i.e. in-vivo Behavioral Approach Tests, BATs; church tower), physiological level (heart rate during the BATs), and subjective level (subjective fear during the BATs as well as height-phobia related questionnaires) at each of the three assessments (i.e. pretreatment, after which the exposure will conducted on the same day, i.e. day 1; posttreatment, which is scheduled approximately 2-3 days after exposure, and follow-up assessment, which will take place 1-month after exposure).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • specific phobia (acrophobia)
  • normal or corrected vision

Exclusion criteria

  • somatic or neurological disease
  • personality disorder
  • bipolar disorder
  • acute drug- or alcoholabuse
  • pharmacological treatment within the past 4 weeks
  • mental retardation
  • any schizophrenic disease

Treatment and study plan

Self-efficacy enhancement

Other

specific instructions regarding the retrieval of mastery experiences during exposure will be given (e.g., pointing out discrepancies between expected negative consequences and actual outcome during exposure; focus on achievements)

Control intervention

Other

specific instructions regarding the retrieval of the exposure session will be given without an emphasis on personal mastery experience (e.g., description of details regarding the virtual reality environment)

Primary outcomes

  1. Change in the Behavioral Approach Test (BAT)

    Time frame: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after treatment, 1 month after)

  2. Change in subjective fear during the BAT

    Time frame: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)

    Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)

  3. Change in heart rate reactivity during the BAT

    Time frame: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)

Secondary outcomes

  1. Change in Acrophobia Questionnaire (AQ)

    Time frame: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after

  2. Change in Attitude Towards Heights Questionnaire (ATHQ)

    Time frame: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after

  3. Change in Danger Expectancy Scale (DES)

    Time frame: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after

  4. Change in Anxiety Expectancy Scale (AES)

    Time frame: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after

Other outcomes

  1. Change in perceived self-efficacy

    Time frame: assessed three times on day 1: before and after the exposure session as well as after the intervention; assessed once at posttreatment (window: 2-3 days after exposure treatment); assessed once at follow-up (window: 1 month after treatment)

    Changes in perceived self-efficacy will be measures with visual analogue scales (VAS)

  2. Becks Depression Inventory II (BDI II)

    Time frame: assessed at pre-treatment (day 1)

  3. State-Trait Anxiety Inventory (STAI)

    Time frame: assessed at pre-treatment (day 1)

  4. Emotion Regulation Questionnaire (ERQ)

    Time frame: assessed at pre-treatment (day 1)

  5. General Self-efficacy Scale (GSE)

    Time frame: assessed at pre-treatment (day 1)

  6. Self-efficacy Scale (SES)

    Time frame: assessed at pre-treatment (day 1)

  7. Resilience Appraisal Scale (RAS)

    Time frame: assessed after the intervention on day 1

  8. Salivary cortisol

    Time frame: assessed twice at each of the three assessments, i.e. pretreatment, posttreatment, follow-up (windows: pretreatment on day 1; approx. 2-3 days after; 1 month after)

  9. Changes in "Test zum kognitiven Schätzen" (TKS)

    Time frame: assessed twice on day 1: before and after exposure treatment

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Enhancing Exposure: the Impact of Self-efficacy Enhancement on Treatment Outcome

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Apr 11, 2018

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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