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Self-efficacy Enhancement and Exposure Therapy

Primary Purpose

Specific Phobia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Self-efficacy enhancement
Control intervention
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia focused on measuring specific phobia, height phobia, exposure, virtual reality, extinction, self-efficacy

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Research and Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Exposure + self-efficacy enhancement

Exposure + control intervention

Exposure only

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Change in the Behavioral Approach Test (BAT)
Change in subjective fear during the BAT
Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)
Change in heart rate reactivity during the BAT

Secondary Outcome Measures

Change in Acrophobia Questionnaire (AQ)
Change in Attitude Towards Heights Questionnaire (ATHQ)
Change in Danger Expectancy Scale (DES)
Change in Anxiety Expectancy Scale (AES)

Full Information

First Posted
March 27, 2017
Last Updated
April 10, 2018
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT03105024
Brief Title
Self-efficacy Enhancement and Exposure Therapy
Official Title
Enhancing Exposure: the Impact of Self-efficacy Enhancement on Treatment Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia
Keywords
specific phobia, height phobia, exposure, virtual reality, extinction, self-efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure + self-efficacy enhancement
Arm Type
Experimental
Arm Description
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.
Arm Title
Exposure + control intervention
Arm Type
Active Comparator
Arm Description
After the virtual exposure session, participants will receive instructions to recall the exposure session
Arm Title
Exposure only
Arm Type
No Intervention
Arm Description
Treatment as usual: no intervention after the exposure session will be given.
Intervention Type
Other
Intervention Name(s)
Self-efficacy enhancement
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Control intervention
Intervention Description
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 Outcome Measure Information:
Title
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)
Title
Change in subjective fear during the BAT
Description
Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)
Time Frame
from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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 Pre-specified Outcome Measures:
Title
Change in perceived self-efficacy
Description
Changes in perceived self-efficacy will be measures with visual analogue scales (VAS)
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)
Title
Becks Depression Inventory II (BDI II)
Time Frame
assessed at pre-treatment (day 1)
Title
State-Trait Anxiety Inventory (STAI)
Time Frame
assessed at pre-treatment (day 1)
Title
Emotion Regulation Questionnaire (ERQ)
Time Frame
assessed at pre-treatment (day 1)
Title
General Self-efficacy Scale (GSE)
Time Frame
assessed at pre-treatment (day 1)
Title
Self-efficacy Scale (SES)
Time Frame
assessed at pre-treatment (day 1)
Title
Resilience Appraisal Scale (RAS)
Time Frame
assessed after the intervention on day 1
Title
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)
Title
Changes in "Test zum kognitiven Schätzen" (TKS)
Time Frame
assessed twice on day 1: before and after exposure treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Zlomuzica, Dr.
Organizational Affiliation
Ruhr-University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Research and Treatment Center
City
Bochum
State/Province
North Rhine-Westphalia
ZIP/Postal Code
44787
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26528152
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.
Results Reference
background
PubMed Identifier
847061
Citation
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.
Results Reference
background

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Self-efficacy Enhancement and Exposure Therapy

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