Self-efficacy Enhancement and Exposure Therapy

NCT03105024 | Completed

• 1 other identifier: FP 1-1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Specific Phobia

Keywords

specific phobia; height phobia; exposure; virtual reality; extinction; self-efficacy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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 Outcomes (9)

• Change in perceived self-efficacy

  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)

Study Arms (3)

Exposure + self-efficacy enhancement

EXPERIMENTAL

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

Exposure + control intervention

ACTIVE COMPARATOR

After the virtual exposure session, participants will receive instructions to recall the exposure session

Other: Control intervention

Exposure only

NO INTERVENTION

Treatment as usual: no intervention after the exposure session will be given.

Interventions

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)

Exposure + self-efficacy enhancement

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)

Exposure + control intervention

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• specific phobia (acrophobia)
• normal or corrected vision

You may not qualify if:

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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Mental Health Research and Treatment Center

Bochum, North Rhine-Westphalia, 44787, Germany

Location

Related Publications (2)

• 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.

  PMID: 26528152 BACKGROUND

• 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.

  PMID: 847061 BACKGROUND

MeSH Terms

Conditions

Phobia, Specific

Study Officials

• Armin Zlomuzica, Dr.

  Ruhr-University Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. / Principal Investigator

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 7, 2017
• Study Start: March 22, 2017
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)