Specific PhobiaNCT03105024
Self-efficacy Enhancement and Exposure Therapy
A study testing Self-efficacy enhancement in people with Specific Phobia, run by Ruhr University of Bochum at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Self-efficacy enhancement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteGermany
- Study dates
- 22 Mar 2017to 29 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- specific phobia (acrophobia)
- normal or corrected vision
Who cannot join
- somatic or neurological disease
- personality disorder
- bipolar disorder
- acute drug- or alcoholabuse
- pharmacological treatment within the past 4 weeks
- mental retardation
- any schizophrenic disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Mental Health Research and Treatment Center
Bochum, North Rhine-Westphalia, 44787
About this study
Official title: 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.
Read the 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).
- Conditions
- Specific Phobia
- Being tested
- Self-efficacy enhancement, Control intervention
- Keywords
- specific phobia, height phobia, exposure, virtual reality, extinction, self-efficacy
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-efficacy enhancementOther
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 interventionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-efficacy enhancement |
| Exposure + control intervention | Active comparator | After the virtual exposure session, participants will receive instructions to recall the exposure session Receives: Other: Control intervention |
| Exposure only | No intervention | Treatment as usual: no intervention after the exposure session will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Behavioral Approach Test (BAT)
Measured: 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)
Measured: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)
Change in heart rate reactivity during the BAT
Measured: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)
Secondary outcomes (4)
Change in Acrophobia Questionnaire (AQ)
Measured: 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)
Measured: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Change in Danger Expectancy Scale (DES)
Measured: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Change in Anxiety Expectancy Scale (AES)
Measured: assessed from pre-treatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start22 Mar 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Zlomuzica, Ruhr University of Bochum
- Investigators
- Armin Zlomuzica, Dr., Principal investigator, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105024
- Sponsor's protocol ID
- FP 1-1
- Status last verified
- Apr 2018
- First submitted
- 27 Mar 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26528152Bandura 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.
PubMed 847061
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Exposure: the Impact of Self-efficacy Enhancement on Treatment Outcome
- ClinicalTrials.gov ID
- NCT03105024
- Acronym / sponsor ID
- FP 1-1
- Conditions
- Specific Phobia
- Keywords
- specific phobia, height phobia, exposure, virtual reality, extinction, self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposure + self-efficacy enhancement | Experimental | Other: Self-efficacy enhancementAfter 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. |
| Exposure + control intervention | Active comparator | Other: Control interventionAfter the virtual exposure session, participants will receive instructions to recall the exposure session |
| Exposure only | No intervention | –Treatment as usual: no intervention after the exposure session will be given. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- specific phobia (acrophobia)
- normal or corrected vision
Key exclusion criteria (7 listed)
- somatic or neurological disease
- personality disorder
- bipolar disorder
- acute drug- or alcoholabuse
- pharmacological treatment within the past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-efficacy enhancementspecific 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) | Other | Exposure + self-efficacy enhancement |
| Control interventionspecific 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) | Other | Exposure + control intervention |
Primary outcome
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)
Change in subjective fear during the BAT
Time frame: from pretreatment through follow-up (i.e. baseline, approx. 2-3 days after, 1 month after)
Subjective fear during the BATs will be measured using the Subjective Units of Distress Scale (SUDS)
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)
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Background: PubMed 26528152Zlomuzica 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.
- Background: PubMed 847061Bandura 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.
- Individual participant dataSharing planned: No
Related trials for Specific Phobia
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Metacognitive Therapy Compared to Cognitive-behavioral Therapy
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Efficacy of Expectancy Focused Exposure Therapy for Anxiety Disorders
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Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Zlomuzica, Dr. principal investigator
Ruhr-University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-efficacy enhancement in people with Specific Phobia, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105024, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.