NCT03562650

Brief Summary

This is an intervention study designed to evaluate a text message based safety behavior fading treatment for people with social anxiety disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2019

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

February 5, 2018

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Social Phobia Inventory (SPIN)

    Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.

    Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)

Secondary Outcomes (2)

  • Subtle Avoidance Frequency Examination(SAFE)

    Change in safety behavior use from baseline to post treatment (4 weeks) and one month follow up (8 weeks)

  • Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

    Change in mindfulness from baseline to post treatment (4 weeks) and one month follow up (8 weeks)

Study Arms (2)

Safety Behavior Fading

EXPERIMENTAL

Participants are asked to pick their three most common safety behaviors from a list and then receive texts every other day for a month reminding them to fade those behaviors.

Behavioral: Safety Behavior Fading

Present Centered

ACTIVE COMPARATOR

Participants receive texts every other day for a month asking them to try to focus on the present that day.

Behavioral: Present Centered

Interventions

Participants are asked to fade their three most common safety behaviors associated with their social anxiety

Safety Behavior Fading

Participants are asked to try to increase their focus on the present.

Present Centered

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Social Phobia Inventory score \> 29

You may not qualify if:

  • receiving therapy
  • changes in the past 4 weeks with medication for emotional difficulties
  • psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University, Department of Psychology

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

  • Cougle JR, Mueller NE, McDermott KA, Wilver NL, Carlton CN, Okey SA. Text message safety behavior reduction for social anxiety: A randomized controlled trial. J Consult Clin Psychol. 2020 May;88(5):445-454. doi: 10.1037/ccp0000494. Epub 2020 Feb 27.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All participants are assigned to a condition and given a treatment justification, but are not told whether they are in the treatment or control condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Active treatment and active treatment control conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 5, 2018

First Posted

June 19, 2018

Study Start

January 27, 2018

Primary Completion

March 27, 2019

Study Completion

March 27, 2019

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations