Self-efficacy Enhancement and Exposure Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Specific Phobia
• Intervention / Treatment: Other: Self-efficacy enhancement; Other: Control intervention

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bochum, North Rhine-Westphalia, Germany, 44787
      • Mental Health Research and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure + self-efficacy enhancement; After the virtual exposure session, participants will receive instructions to recall the exposure session with a focus on the personal mastery experiences/achievements made during exposure.	Other: Self-efficacy enhancement; 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)
Active Comparator: Exposure + control intervention; After the virtual exposure session, participants will receive instructions to recall the exposure session	Other: Control intervention; 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)
No Intervention: Exposure only; Treatment as usual: no intervention after the exposure session will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Behavioral Approach Test (BAT)		from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after treatment, 1 month after)
Change in subjective fear during the BAT	Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)	from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)
Change in heart rate reactivity during the BAT		from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Acrophobia Questionnaire (AQ)	assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Change in Attitude Towards Heights Questionnaire (ATHQ)	assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Change in Danger Expectancy Scale (DES)	assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Change in Anxiety Expectancy Scale (AES)	assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived self-efficacy	Changes in perceived self-efficacy will be measures with visual analogue scales (VAS)	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)
Becks Depression Inventory II (BDI II)		assessed at pre-treatment (day 1)
State-Trait Anxiety Inventory (STAI)		assessed at pre-treatment (day 1)
Emotion Regulation Questionnaire (ERQ)		assessed at pre-treatment (day 1)
General Self-efficacy Scale (GSE)		assessed at pre-treatment (day 1)
Self-efficacy Scale (SES)		assessed at pre-treatment (day 1)
Resilience Appraisal Scale (RAS)		assessed after the intervention on day 1
Salivary cortisol		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)
Changes in "Test zum kognitiven Schätzen" (TKS)		assessed twice on day 1: before and after exposure treatment

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Principal Investigator: Armin Zlomuzica, Dr., Ruhr-University Bochum

Publications and helpful links

General Publications

• Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
• Zlomuzica A, Preusser F, Schneider S, Margraf J. Increased perceived self-efficacy facilitates the extinction of fear in healthy participants. Front Behav Neurosci. 2015 Oct 16;9:270. doi: 10.3389/fnbeh.2015.00270. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2017
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: virtual reality; exposure; self-efficacy; specific phobia; extinction; height phobia
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: FP 1-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No