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

NCT03233113 | Completed

• 1 other identifier: 16-0700
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.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

Keywords

Exposure therapy; Cognitive-behavioral therapy; Anxiety disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 1-month follow-up

Secondary Outcomes (9)

• Change from baseline FSQ Score at 0-48 hours post-treatment

  Baseline, Within approximately 48 hours post final treatment

• Change from baseline Spider BAT Score at 0-48 hours post-treatment

  Baseline, Within approximately 48 hours post final treatment

• Treatment Acceptability and Adherence Scale Score at Baseline

  Baseline

• TAAS Score at 0-48 hours post-treatment

  Within approximately 48 hours post final treatment

• TAAS Score at 1-month follow-up

  1-month follow-up

Study Arms (2)

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.

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.

Behavioral: Exposure therapy

Interventions

Exposure therapy BEHAVIORAL

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.

Also known as: Cognitive-behavioral therapy for anxiety disorders

Exposure and response prevention; Exposure with judicious safety behaviors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Society for a Science of Clinical Psychology: collaborator
• Association for Behavioral and Cognitive Therapies: collaborator

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (3)

• 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.

  PMID: 27475477 BACKGROUND

• 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.

  PMID: 18199423 BACKGROUND

• 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.

  PMID: 7642758 BACKGROUND

MeSH Terms

Conditions

Phobia, Specific; Anxiety Disorders

Interventions

Implosive Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shannon M Blakey, M.S.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 28, 2017
• Study Start: September 20, 2016
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)