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The Effects of Safety Seeking Behaviors During Exposure Therapy for Adults With Spider Phobia

Primary Purpose

Specific Phobia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure therapy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia focused on measuring Exposure therapy, Cognitive-behavioral therapy, Anxiety disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being at least 18 years old
  • Presence of clinically significant spider phobia
  • English fluency
  • Willingness to attend and audiotape all study sessions

Exclusion Criteria:

  • 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

Sites / Locations

  • University of North Carolina, Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exposure and response prevention

Exposure with judicious safety behaviors

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 24, 2017
Last Updated
January 11, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Society for a Science of Clinical Psychology, Association for Behavioral and Cognitive Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT03233113
Brief Title
The Effects of Safety Seeking Behaviors During Exposure Therapy for Adults With Spider Phobia
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
September 13, 2017 (Actual)
Study Completion Date
September 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Society for a Science of Clinical Psychology, Association for Behavioral and Cognitive Therapies

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia
Keywords
Exposure therapy, Cognitive-behavioral therapy, Anxiety disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Pre-determined condition allocation was listed in an Excel spreadsheet and concealed with black cell masking color. Interested individuals who met initial eligibility criteria during a pre-enrollment phone screening were entered in the order of screening in the assignment Excel spreadsheet (that was already masked to conceal condition assignment). Only the participant's therapist viewed the allocated condition immediately prior to the first treatment session by temporarily lifting the cell mask.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure and response prevention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exposure with judicious safety behaviors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure therapy
Other Intervention Name(s)
Cognitive-behavioral therapy for anxiety disorders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Fear of Spiders Questionnaire Score at 1-month follow-up
Description
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.
Time Frame
Baseline, 1-month follow-up
Title
Change from baseline Spider Behavioral Approach Task Score at 1-month follow-up
Description
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.
Time Frame
Baseline, 1-month follow-up
Secondary Outcome Measure Information:
Title
Change from baseline FSQ Score at 0-48 hours post-treatment
Description
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.
Time Frame
Baseline, Within approximately 48 hours post final treatment
Title
Change from baseline Spider BAT Score at 0-48 hours post-treatment
Description
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.
Time Frame
Baseline, Within approximately 48 hours post final treatment
Title
Treatment Acceptability and Adherence Scale Score at Baseline
Description
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.
Time Frame
Baseline
Title
TAAS Score at 0-48 hours post-treatment
Description
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.
Time Frame
Within approximately 48 hours post final treatment
Title
TAAS Score at 1-month follow-up
Description
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.
Time Frame
1-month follow-up
Title
Change from baseline BAT Peak Distress Score at 0-48 hours post-treatment
Description
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.
Time Frame
Baseline, Within approximately 48 hours post final treatment
Title
Change from baseline BAT Peak Distress Score at 1-month follow-up
Description
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.
Time Frame
Baseline, 1-month follow-up
Title
Change from baseline In-Vivo Distress Tolerance Score at 0-48 hours post-treatment
Description
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.
Time Frame
Baseline, Within approximately 48 hours post final treatment
Title
Change from baseline In-Vivo Distress Tolerance Score at 1-month follow-up
Description
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.
Time Frame
Baseline, 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being at least 18 years old Presence of clinically significant spider phobia English fluency Willingness to attend and audiotape all study sessions Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon M Blakey, M.S.
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
27475477
Citation
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.
Results Reference
background
PubMed Identifier
18199423
Citation
Rachman 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.
Results Reference
background
PubMed Identifier
7642758
Citation
Szymanski 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.
Results Reference
background

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The Effects of Safety Seeking Behaviors During Exposure Therapy for Adults With Spider Phobia

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