Specific PhobiaNCT03233113
The Effects of Safety Seeking Behaviors During Exposure Therapy for Adults With Spider Phobia
A study testing Exposure therapy in people with Specific Phobia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Exposure-based cognitive-behavioral therapy (i.e., "exposure therapy"), which entails repeated and prolonged confrontation with feared situations/stimuli, is the most effective treatment for anxiety disorders (e.g., arachnophobia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Specific Phobia
- What is being tested?
- Exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2016to 13 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being at least 18 years old
- Presence of clinically significant spider phobia
- English fluency
- Willingness to attend and audiotape all study sessions
Who cannot join
- Spider or bee allergies
- Previous trial of exposure-based cognitive-behavioral therapy for any anxiety problem
- Current alcohol or substance use disorder
- Lifetime symptoms of mania or psychosis
- Voluntarily report current suicidal ideation
- Complete 10 or more steps on the behavioral approach task administered at the pre-treatment assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Response Prevention or Response Permission? A Randomized Controlled Trial of the "Judicious Use of Safety Behaviors" During Exposure Therapy (Institutional Review Board Title: Overcome Your Spider Phobia)
Exposure-based cognitive-behavioral therapy (i.e., "exposure therapy"), which entails repeated and prolonged confrontation with feared situations/stimuli, is the most effective treatment for anxiety disorders (e.g., arachnophobia). Safety behaviors are actions performed to prevent, minimize, or escape a feared catastrophe and/or associated distress (e.g., wearing thick shoes or gloves when around areas where there might be spiders). It is understood that safety behaviors contribute to the development and maintenance of anxiety disorders; accordingly, patients' safety behaviors are traditionally eliminated as soon as possible during exposure therapy (i.e., "response prevention"). Unfortunately, not everyone who receives exposure therapy benefits from this approach. To address the limitations of exposure's effectiveness, some experts have questioned the clinical convention of response prevention during exposure therapy. Specifically, they propose the "judicious use of safety behaviors": the careful and strategic incorporation of safety behaviors during exposure therapy. The controversial role of permitting safety behaviors during exposure has garnered substantial research attention, yet study findings are mixed. The current study, therefore, was designed to improve upon the methodological limitations of previous related research and examine the relative efficacy of traditional exposure with response prevention (E/RP) and the experimental exposure with the judicious use of safety behaviors (E/JU) in a sample of adults with arachnophobia. In light of previous related research, several hypotheses were made regarding the short- (posttreatment) and long-term (1-month follow-up) treatment effects:
- Primary outcomes: E/RP participants will demonstrate greater improvement in spider phobia than the E/JU participants along behavioral and self-report symptom measures at follow-up.
- Secondary outcomes: Treatment acceptability and tolerability will be higher for E/JU participants, relative to E/RP participants, before beginning exposures and at posttreatment, but not at follow-up. In addition, hypothesize that E/RP participants will report greater reductions in peak distress and greater improvements in distress tolerance relative to E/JU participants at follow-up.
- Additional outcome: Exploratory analyses will be conducted to compare the relative rate of behavioral approach and exposure goal completion between treatment conditions.
- Conditions
- Specific Phobia
- Being tested
- Exposure therapy
- Keywords
- Exposure therapy, Cognitive-behavioral therapy, Anxiety disorders
- Medical subject headings
- Phobia, Specific, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure therapyBehavioural
Also called Cognitive-behavioral therapy for anxiety disorders
Exposure therapy (i.e., exposure-based cognitive behavioral therapy) for spider phobia according to condition-specific, scripted treatment manuals inspired by evidence-based exposure programs for anxiety/phobias (for both arms: Abramowitz, Deacon, \& Whiteside, 20011; Antony, Craske, \& Barlow, 1995) as well as the seminal account of the "judicious use of safety behaviors" thesis (for the experimental arm only: Rachman, Radomsky, \& Shafran, 2008). Exposure and response prevention involves confronting a live spider while resisting safety-seeking behaviors; exposure with judicious safety behaviors involves strategically using safety behaviors while confronting a live spider.
| Study group | Role | What they receive |
|---|---|---|
| Exposure and response prevention | Active comparator | Exposure therapy with response prevention involves four hour-long individual sessions with a trained exposure therapist. Session 1 involves functional assessment, psychoeducation, presentation of the treatment rationale, and treatment planning. Sessions 2-4 involve a review of the model/treatment rationale, condition-specific reminders about how to prevent engaging in any safety behaviors during exposure, a 30-minute in-vivo exposure trial involving a live tarantula, and post-exposure processing. Session 4 also involves a discussion of relapse prevention strategies. Receives: Behavioral: Exposure therapy |
| Exposure with judicious safety behaviors | Experimental | Exposure therapy with judiciously used safety behaviors for spider phobia involves four hour-long individual sessions with a trained exposure therapist. Session 1 involves functional assessment, psychoeducation, presentation of the treatment rationale, and treatment planning. Sessions 2-4 involve a review of the model/treatment rationale, condition-specific reminders about how to strategically incorporate safety behaviors during exposure, a 30-minute in-vivo exposure trial involving a live tarantula, and post-exposure processing. Session 4 also involves a discussion of relapse prevention strategies. Receives: Behavioral: Exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fear of Spiders Questionnaire Score at 1-month follow-up
The Fear of Spiders Questionnaire (FSQ; Szymanski \& O'Donahue, 1995) is an 18-item self-report measure of spider phobia. Participants rate their agreement with each statement (e.g., "If I saw a spider now, I would think it will harm me") on a scale of 0 (totally disagree) to 7 (totally agree). Possible total scores range from 0 to 126, such that higher scores indicate greater spider fear.
Measured: Baseline, 1-month follow-up
Change from baseline Spider Behavioral Approach Task Score at 1-month follow-up
The Spider Behavioral Approach Task (BAT) includes 13 rank-ordered steps ranging from standing at the opposite end of a room containing a tarantula enclosed in a closed terrarium covered with a sheet to allowing the tarantula to crawl up one's bare arm. A participant must perform a BAT step for 10 consecutive seconds for the step to count as completed. BAT scores are recorded as the number of the highest step completed.
Measured: Baseline, 1-month follow-up
Secondary outcomes (9)
Change from baseline FSQ Score at 0-48 hours post-treatment
The FSQ is an 18-item self-report measure of spider phobia that is included in the baseline and post-treatment assessments. The post-treatment assessment is administered immediately post-treatment (at the end of the fourth/final treatment session), although participants with scheduling conflicts may complete the post-treatment assessment during another visit as long as it occurs within 48 hours of the final treatment (4th overall) visit.
Measured: Baseline, Within approximately 48 hours post final treatment
Change from baseline Spider BAT Score at 0-48 hours post-treatment
The Spider BAT, a behavioral measure of spider phobia, is included in the baseline and post-treatment (within 48 hours of the fourth/final treatment session) assessments.
Measured: Baseline, Within approximately 48 hours post final treatment
Treatment Acceptability and Adherence Scale Score at Baseline
The Treatment Acceptability and Adherence Scale (TAAS) is a 10-item self-report measure of treatment acceptability and predicted adherence. Participants rate each statement (e.g., "If I participated in this treatment, I would be able to adhere to its requirements") on a 1 (disagree strongly) to 7 (agree strongly) scale. Possible total scores range from 10 to 70, with higher scores indicating greater treatment acceptability/anticipated adherence.
Measured: Baseline
TAAS Score at 0-48 hours post-treatment
The TAAS is a 10-item self-report measure of treatment acceptability and predicted adherence. Participants rate each statement (e.g., "If I participated in this treatment, I would be able to adhere to its requirements") on a 1 (disagree strongly) to 7 (agree strongly) scale. Possible total scores range from 10 to 70, with higher scores indicating greater treatment acceptability/anticipated adherence.
Measured: Within approximately 48 hours post final treatment
TAAS Score at 1-month follow-up
The TAAS is a 10-item self-report measure of treatment acceptability and predicted adherence. Participants rate each statement (e.g., "If I participated in this treatment, I would be able to adhere to its requirements") on a 1 (disagree strongly) to 7 (agree strongly) scale. Possible total scores range from 10 to 70, with higher scores indicating greater treatment acceptability/anticipated adherence.
Measured: 1-month follow-up
Change from baseline BAT Peak Distress Score at 0-48 hours post-treatment
Immediately after completing each step of the BAT (at the baseline and post-treatment assessments), participants are asked to verbally report their (a) anxiety and (b) disgust, using a scale of 0 (not at all) to 10 (maximum). The highest self-reported values are separately recorded as peak BAT anxiety and peak BAT disgust, which are summed together to form a single peak BAT distress value. The post-treatment assessment is administered immediately post-treatment (at the end of the fourth/final treatment session), although participants with scheduling conflicts may complete the post-treatment assessment during another visit as long as it occurs within 48 hours of the final treatment (4th overall) visit.
Measured: Baseline, Within approximately 48 hours post final treatment
Change from baseline BAT Peak Distress Score at 1-month follow-up
Immediately after completing each step of the BAT, participants are asked to verbally report their (a) anxiety and (b) disgust, using a scale of 0 (not at all) to 10 (maximum). The highest self-reported values are separately recorded as peak BAT anxiety and peak BAT disgust, which are summed together to form a single peak BAT distress value.
Measured: Baseline, 1-month follow-up
Change from baseline In-Vivo Distress Tolerance Score at 0-48 hours post-treatment
Immediately after completing the BAT, participants are asked: "Regardless of how intense your distress was, how well did you tolerate your distress? That is, how well were you able to manage whatever emotions and sensations came up during the exercise, even if they were very strong?" Participants verbally report ratings of state distress tolerance using a 0 (not at all able to tolerate my distress) to 10 (completely able to tolerate my distress) scale. The post-treatment assessment is administered immediately post-treatment (at the end of the fourth/final treatment session), although participants with scheduling conflicts may complete the post-treatment assessment during another visit as long as it occurs within 48 hours of the final treatment (4th overall) visit.
Measured: Baseline, Within approximately 48 hours post final treatment
Change from baseline In-Vivo Distress Tolerance Score at 1-month follow-up
Immediately after completing the BAT, participants are asked to verbally report their BAT distress tolerance, using a 0 (not at all able to tolerate my distress) to 10 (completely able to tolerate my distress) scale.
Measured: Baseline, 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start20 Sep 2016
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Model description
- The current study follows a two-arm, parallel group RCT study design. Participants are randomized to either the active control arm (Exposure and Response Prevention) or the experimental arm (Exposure with Judicious Safety Behaviors). Participants are not offered the opportunity to choose their study condition, nor are they provided with an explanation of the difference between their assigned treatment arm and the alternative treatment arm. Randomization was achieved prior to initial participant recruitment via a random number generator with the condition that an equal number of participants be randomized to each condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Society for a Science of Clinical Psychology, Association for Behavioral and Cognitive Therapies
- Responsible party
- Sponsor
- Investigators
- Shannon M Blakey, M.S., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233113
- Sponsor's protocol ID
- 16-0700
- Status last verified
- Jan 2018
- First submitted
- 24 Jul 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individuals may contact the primary investigator (Shannon M. Blakey) to request access to the Individual Patient Data (IPD) after the termination of the study and publication of the primary outcomes manuscript.
Publications
Blakey SM, Abramowitz JS. The effects of safety behaviors during exposure therapy for anxiety: Critical analysis from an inhibitory learning perspective. Clin Psychol Rev. 2016 Nov;49:1-15. doi: 10.1016/j.cpr.2016.07.002. Epub 2016 Jul 25.
PubMed 27475477Rachman S, Radomsky AS, Shafran R. Safety behaviour: a reconsideration. Behav Res Ther. 2008 Feb;46(2):163-73. doi: 10.1016/j.brat.2007.11.008. Epub 2007 Nov 28.
PubMed 18199423Szymanski J, O'Donohue W. Fear of Spiders Questionnaire. J Behav Ther Exp Psychiatry. 1995 Mar;26(1):31-4. doi: 10.1016/0005-7916(94)00072-t.
PubMed 7642758
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Prevention or Response Permission? A Randomized Controlled Trial of the "Judicious Use of Safety Behaviors" During Exposure Therapy (Institutional Review Board Title: Overcome Your Spider Phobia)
- ClinicalTrials.gov ID
- NCT03233113
- Acronym / sponsor ID
- 16-0700
- Conditions
- Specific Phobia
- Keywords
- Exposure therapy, Cognitive-behavioral therapy, Anxiety disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Society for a Science of Clinical Psychology, Association for Behavioral and Cognitive Therapies
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 28 Jul 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.
Exposure-based cognitive-behavioral therapy (i.e., "exposure therapy"), which entails repeated and prolonged confrontation with feared situations/stimuli, is the most effective treatment for anxiety disorders (e.g., arachnophobia). Safety behaviors are actions performed to prevent, minimize, or escape a feared catastrophe and/or associated distress (e.g., wearing thick shoes or gloves when around areas where there might be spiders). It is understood that safety behaviors contribute to the development and maintenance of anxiety disorders; accordingly, patients' safety behaviors are traditionally eliminated as soon as possible during exposure therapy (i.e., "response prevention"). Unfortunately, not everyone who receives exposure therapy benefits from this approach. To address the limitations of exposure's effectiveness, some experts have questioned the clinical convention of response prevention during exposure therapy. Specifically, they propose the "judicious use of safety behaviors": the careful and strategic incorporation of safety behaviors during exposure therapy. The controversial role of permitting safety behaviors during exposure has garnered substantial research attention, yet study findings are mixed. The current study, therefore, was designed to improve upon the methodological limitations of previous related research and examine the relative efficacy of traditional exposure with response prevention (E/RP) and the experimental exposure with the judicious use of safety behaviors (E/JU) in a sample of adults with arachnophobia. In light of previous related research, several hypotheses were made regarding the short- (posttreatment) and long-term (1-month follow-up) treatment effects:
- Primary outcomes: E/RP participants will demonstrate greater improvement in spider phobia than the E/JU participants along behavioral and self-report symptom measures at follow-up.
- Secondary outcomes: Treatment acceptability and tolerability will be higher for E/JU participants, relative to E/RP participants, before beginning exposures and at posttreatment, but not at follow-up. In addition, hypothesize that E/RP participants will report greater reductions in peak distress and greater improvements in distress tolerance relative to E/JU participants at follow-up.
- Additional outcome: Exploratory analyses will be conducted to compare the relative rate of behavioral approach and exposure goal completion between treatment conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The current study follows a two-arm, parallel group RCT study design. Participants are randomized to either the active control arm (Exposure and Response Prevention) or the experimental arm (Exposure with Judicious Safety Behaviors). Participants are not offered the opportunity to choose their study condition, nor are they provided with an explanation of the difference between their assigned treatment arm and the alternative treatment arm. Randomization was achieved prior to initial participant recruitment via a random number generator with the condition that an equal number of participants be randomized to each condition.
| Arm | Type | Receives |
|---|---|---|
| Exposure and response prevention | Active comparator | Behavioral: Exposure therapyExposure therapy with response prevention involves four hour-long individual sessions with a trained exposure therapist. Session 1 involves functional assessment, psychoeducation, presentation of the treatment rationale, and treatment planning. Sessions 2-4 involve a review of the model/treatment rationale, condition-specific reminders about how to prevent engaging in any safety behaviors during exposure, a 30-minute in-vivo exposure trial involving a live tarantula, and post-exposure processing. Session 4 also involves a discussion of relapse prevention strategies. |
| Exposure with judicious safety behaviors | Experimental | Behavioral: Exposure therapyExposure therapy with judiciously used safety behaviors for spider phobia involves four hour-long individual sessions with a trained exposure therapist. Session 1 involves functional assessment, psychoeducation, presentation of the treatment rationale, and treatment planning. Sessions 2-4 involve a review of the model/treatment rationale, condition-specific reminders about how to strategically incorporate safety behaviors during exposure, a 30-minute in-vivo exposure trial involving a live tarantula, and post-exposure processing. Session 4 also involves a discussion of relapse prevention strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being at least 18 years old
- Presence of clinically significant spider phobia
- English fluency
- Willingness to attend and audiotape all study sessions
Key exclusion criteria (6 listed)
- Spider or bee allergies
- Previous trial of exposure-based cognitive-behavioral therapy for any anxiety problem
- Current alcohol or substance use disorder
- Lifetime symptoms of mania or psychosis
- Voluntarily report current suicidal ideation
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 |
|---|---|---|
| Exposure therapyAlso: Cognitive-behavioral therapy for anxiety disordersExposure therapy (i.e., exposure-based cognitive behavioral therapy) for spider phobia according to condition-specific, scripted treatment manuals inspired by evidence-based exposure programs for anxiety/phobias (for both arms: Abramowitz, Deacon, \& Whiteside, 20011; Antony, Craske, \& Barlow, 1995) as well as the seminal account of the "judicious use of safety behaviors" thesis (for the experimental arm only: Rachman, Radomsky, \& Shafran, 2008). Exposure and response prevention involves confronting a live spider while resisting safety-seeking behaviors; exposure with judicious safety behaviors involves strategically using safety behaviors while confronting a live spider. | Behavioural | Exposure and response prevention, Exposure with judicious safety behaviors |
Primary outcome
Change from baseline Fear of Spiders Questionnaire Score at 1-month follow-up
Time frame: Baseline, 1-month follow-up
The Fear of Spiders Questionnaire (FSQ; Szymanski \& O'Donahue, 1995) is an 18-item self-report measure of spider phobia. Participants rate their agreement with each statement (e.g., "If I saw a spider now, I would think it will harm me") on a scale of 0 (totally disagree) to 7 (totally agree). Possible total scores range from 0 to 126, such that higher scores indicate greater spider fear.
Change from baseline Spider Behavioral Approach Task Score at 1-month follow-up
Time frame: Baseline, 1-month follow-up
The Spider Behavioral Approach Task (BAT) includes 13 rank-ordered steps ranging from standing at the opposite end of a room containing a tarantula enclosed in a closed terrarium covered with a sheet to allowing the tarantula to crawl up one's bare arm. A participant must perform a BAT step for 10 consecutive seconds for the step to count as completed. BAT scores are recorded as the number of the highest step completed.
9 secondary outcomes
Change from baseline FSQ Score at 0-48 hours post-treatment
Time frame: Baseline, Within approximately 48 hours post final treatment
Change from baseline Spider BAT Score at 0-48 hours post-treatment
Time frame: Baseline, Within approximately 48 hours post final treatment
Treatment Acceptability and Adherence Scale Score at Baseline
Time frame: Baseline
TAAS Score at 0-48 hours post-treatment
Time frame: Within approximately 48 hours post final treatment
TAAS Score at 1-month follow-up
Time frame: 1-month follow-up
Change from baseline BAT Peak Distress Score at 0-48 hours post-treatment
Time frame: Baseline, Within approximately 48 hours post final treatment
Change from baseline BAT Peak Distress Score at 1-month follow-up
Time frame: Baseline, 1-month follow-up
Change from baseline In-Vivo Distress Tolerance Score at 0-48 hours post-treatment
Time frame: Baseline, Within approximately 48 hours post final treatment
Change from baseline In-Vivo Distress Tolerance Score at 1-month follow-up
Time frame: Baseline, 1-month follow-up
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 16 Jan 2018.
- Background: PubMed 27475477Blakey SM, Abramowitz JS. The effects of safety behaviors during exposure therapy for anxiety: Critical analysis from an inhibitory learning perspective. Clin Psychol Rev. 2016 Nov;49:1-15. doi: 10.1016/j.cpr.2016.07.002. Epub 2016 Jul 25.
- Background: PubMed 18199423Rachman S, Radomsky AS, Shafran R. Safety behaviour: a reconsideration. Behav Res Ther. 2008 Feb;46(2):163-73. doi: 10.1016/j.brat.2007.11.008. Epub 2007 Nov 28.
- Background: PubMed 7642758Szymanski J, O'Donohue W. Fear of Spiders Questionnaire. J Behav Ther Exp Psychiatry. 1995 Mar;26(1):31-4. doi: 10.1016/0005-7916(94)00072-t.
- Individual participant dataSharing planned: No. Individuals may contact the primary investigator (Shannon M. Blakey) to request access to the Individual Patient Data (IPD) after the termination of the study and publication of the primary outcomes manuscript.
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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.
Shannon M Blakey, M.S. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure therapy in people with Specific Phobia, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 4 inclusion and 6 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 16 Jan 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 United States. 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 from baseline Fear of Spiders Questionnaire Score at 1-month follow-up (time frame: Baseline, 1-month follow-up). The study lists 2 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 NCT03233113, which also lists 3 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 16 Jan 2018.