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OpenTrials
Completed

NCT Number: NCT03101553

Computerized Treatment for Social Anxiety

The present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on social anxiety symptoms will be mediated by changes in social anxiety-related interpretation bias; and 5) The effects of condition will be maintained at the 3-month follow-up assessment.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Department of Psychology

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current diagnosis of Social Anxiety Disorder according to DSM-5 criteria
  • SPIN score greater than or equal to 30
  • Must report sufficient motivation to complete treatment (i.e., score of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation))

Exclusion criteria

  • Concurrent psychotherapy or treatment for social anxiety disorder
  • Clinically significant suicidality
  • Current Alcohol Use Disorder of "Severe" severity or higher
  • Current Non-alcohol Substance Use Disorder of "Moderate" severity or higher
  • Recent changes (less than four weeks) in psychiatric medication
  • History of psychotic symptoms
  • May not have participated in a similar computerized treatment program

Treatment and study plan

Interpretation Bias Modification

Behavioral

Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.

Progressive Muscle Relaxation

Behavioral

Eight 15-minute sessions of progressive muscle relaxation (PMR).

Primary outcomes

  1. Social Phobia Inventory (SPIN; Davidson, 1995)

    Time frame: change from baseline at one-week post treatment and 3-months post-treatment

    Measures past-week social anxiety symptom severity

Secondary outcomes

  1. Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)

    Time frame: change from baseline at one-week post treatment and 3-months post-treatment

    Measures depressive symptom severity

  2. Beck Anxiety Inventory (BAI; Steer & Beck, 1997)

    Time frame: change from baseline at one-week post treatment and 3-months post-treatment

    Measure anxious symptom severity

  3. Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)

    Time frame: change from baseline at one-week post treatment and 3-months post-treatment

    Measure of strength of evaluation related threat interpretation bias

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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