Clinical trial NCT03105024: Self-efficacy Enhancement and Exposure Therapy
Official title: Enhancing Exposure: the Impact of Self-efficacy Enhancement on Treatment Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Keywords: specific phobia
height phobia
exposure
virtual reality
extinction
self-efficacy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in the Behavioral Approach Test (BAT)
timeFrame: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after treatment, 1 month after)
measure: Change in subjective fear during the BAT
timeFrame: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)
measure: Change in heart rate reactivity during the BAT
timeFrame: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)
Secondary outcomes:
measure: Change in Acrophobia Questionnaire (AQ)
timeFrame: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
measure: Change in Attitude Towards Heights Questionnaire (ATHQ)
timeFrame: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
measure: Change in Danger Expectancy Scale (DES)
timeFrame: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
measure: Change in Anxiety Expectancy Scale (AES)
timeFrame: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Other outcomes:
measure: Change in perceived self-efficacy
timeFrame: 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)
measure: Becks Depression Inventory II (BDI II)
timeFrame: assessed at pre-treatment (day 1)
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: assessed at pre-treatment (day 1)
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: assessed at pre-treatment (day 1)
measure: General Self-efficacy Scale (GSE)
timeFrame: assessed at pre-treatment (day 1)
measure: Self-efficacy Scale (SES)
timeFrame: assessed at pre-treatment (day 1)
measure: Resilience Appraisal Scale (RAS)
timeFrame: assessed after the intervention on day 1
measure: Salivary cortisol
timeFrame: 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)
measure: Changes in "Test zum kognitiven Schätzen" (TKS)
timeFrame: assessed twice on day 1: before and after exposure treatment
Locations:
city: Bochum
country: Germany
facility: Mental Health Research and Treatment Center
state: North Rhine-Westphalia
Study officials:
affiliation: Ruhr-University Bochum
name: Armin Zlomuzica, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.