Clinical trial NCT03233113: 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
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Keywords: Exposure therapy
Cognitive-behavioral therapy
Anxiety disorders
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Society for a Science of Clinical Psychology
name: Association for Behavioral and Cognitive Therapies
First posted: 2017-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

1. 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.
2. 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.
3. Additional outcome: Exploratory analyses will be conducted to compare the relative rate of behavioral approach and exposure goal completion between treatment conditions.


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

Primary outcomes:
measure: Change from baseline Fear of Spiders Questionnaire Score at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline Spider Behavioral Approach Task Score at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
Secondary outcomes:
measure: Change from baseline FSQ Score at 0-48 hours post-treatment
timeFrame: Baseline, Within approximately 48 hours post final treatment
measure: Change from baseline Spider BAT Score at 0-48 hours post-treatment
timeFrame: Baseline, Within approximately 48 hours post final treatment
measure: Treatment Acceptability and Adherence Scale Score at Baseline
timeFrame: Baseline
measure: TAAS Score at 0-48 hours post-treatment
timeFrame: Within approximately 48 hours post final treatment
measure: TAAS Score at 1-month follow-up
timeFrame: 1-month follow-up
measure: Change from baseline BAT Peak Distress Score at 0-48 hours post-treatment
timeFrame: Baseline, Within approximately 48 hours post final treatment
measure: Change from baseline BAT Peak Distress Score at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
measure: Change from baseline In-Vivo Distress Tolerance Score at 0-48 hours post-treatment
timeFrame: Baseline, Within approximately 48 hours post final treatment
measure: Change from baseline In-Vivo Distress Tolerance Score at 1-month follow-up
timeFrame: Baseline, 1-month follow-up
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Shannon M Blakey, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.