Self-efficacy Enhancement and Exposure Therapy

Specific Phobia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105024
• Other study ID #: FP 1-1
• Status: Completed
• Phase: N/A
• First received: March 27, 2017
• Last updated: April 10, 2018
• Start date: March 22, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: April 2018
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Specific Phobia

Intervention

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)
• 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)

Locations

Country	Name	City	State
Germany	Mental Health Research and Treatment Center	Bochum	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Becks Depression Inventory II (BDI II)		assessed at pre-treatment (day 1)
Other	State-Trait Anxiety Inventory (STAI)		assessed at pre-treatment (day 1)
Other	Emotion Regulation Questionnaire (ERQ)		assessed at pre-treatment (day 1)
Other	General Self-efficacy Scale (GSE)		assessed at pre-treatment (day 1)
Other	Self-efficacy Scale (SES)		assessed at pre-treatment (day 1)
Other	Resilience Appraisal Scale (RAS)		assessed after the intervention on day 1
Other	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)
Other	Changes in "Test zum kognitiven Schätzen" (TKS)		assessed twice on day 1: before and after exposure treatment
Primary	Change in the Behavioral Approach Test (BAT)		from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after treatment, 1 month after)
Primary	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)
Primary	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	Change in Acrophobia Questionnaire (AQ)		assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Secondary	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
Secondary	Change in Danger Expectancy Scale (DES)		assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Secondary	Change in Anxiety Expectancy Scale (AES)		assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after