NCT03297619

Brief Summary

The goal of this study is to compare the efficacy and mechanisms of change of two self-help books for social anxiety in college students in a randomized controlled trial. One book is based on traditional cognitive behavioral therapy and one is based on acceptance and commitment therapy. This study will test the following hypotheses: Hypothesis 1: The CBT and ACT book conditions will both experience decreased social anxiety and distress. Life satisfaction and values progress will increase in both conditions. Hypothesis 2: The CBT condition will result in greater use of reappraisal, the ACT condition will not. Hypothesis 3: The ACT condition will result in greater use of defusion and decreased psychological inflexibility; the CBT condition will not. Hypothesis 4: Changes in experiential avoidance and defusion will predict changes in social anxiety and values progress in the ACT condition. Hypothesis 5: Changes in reappraisal will predict changes in social anxiety in the CBT condition. Change in values progress will be predicted by change in social anxiety in the CBT condition. Hypothesis 6: The association between social anxiety/negative affect and values progress will decrease or disappear in the ACT condition (i.e., decoupling), and remain the same in the CBT condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

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

First Submitted

Initial submission to the registry

September 13, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 16, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

September 13, 2017

Last Update Submit

November 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Liebowitz Social Anxiety Scale - Self Report (Fresco et al., 2001)

    A self-report measure of fear and avoidance of social situations.

    Posttreatment (9 weeks after baseline)

Secondary Outcomes (3)

  • General Health Questionnaire-12 (Banks et al., 1980; Goldberg, 1978)

    Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles And Activities Short Form 8 v2.0 (Hahn et al., 2014)

    Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)

  • Valuing Questionnaire - Progress subscale (Smout, Davies, Burns, & Christie, 2014)

    Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)

Other Outcomes (4)

  • Believability of Anxious Feelings and Thoughts Questionnaire (Herzberg et al., 2012)

    Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)

  • Cognitive Fusion Questionnaire (Gillanders et al., 2014)

    Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)

  • Appraisal of Social Concerns Scale (Telch et al., 2004)

    Baseline, midtreatment (5 weeks after baseline), and posttreatment (9 weeks after baseline)

  • +1 more other outcomes

Study Arms (2)

ACT self-help book condition

EXPERIMENTAL

Participants in this condition will be assigned to read The Mindfulness and Acceptance Workbook for Social Anxiety and Shyness by Fleming and Kocovski (2013), a self-help book based on acceptance and commitment therapy.

Behavioral: Mindfulness and Acceptance Workbook for Social Anxiety and Shyness

CBT self-help book condition

ACTIVE COMPARATOR

Participants in this condition will be assigned to read The Shyness and Social Anxiety Workbook by Antony and Swinson (2008), a self-help book based on cognitive-behavioral therapy for social anxiety.

Behavioral: The Shyness and Social Anxiety Workbook

Interventions

Participants assigned to this condition will be asked to read this self-help book over an 8-week period.

ACT self-help book condition

Participants assigned to this condition will be asked to read this self-help book over an 8-week period (with some chapters omitted).

CBT self-help book condition

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older
  • Enrolled at Utah State University
  • Have not participated in other self-help studies run by the USU CBS Lab
  • Interested in using self-help book for social anxiety
  • Scoring at least a 6 on the Mini Social Phobia Inventory (Mini-SPIN), a validated social anxiety screening measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (14)

  • Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: A brief screening assessment for generalized social anxiety disorder. Depress Anxiety. 2001;14(2):137-40. doi: 10.1002/da.1055.

    PMID: 11668666BACKGROUND
  • Antony, M. M., & Swinson, R. P. (2008). The shyness and social anxiety workbook. Oakland, CA: New Harbinger Publications, Inc.

    BACKGROUND
  • Fleming, J. E., & Kocovski, N. L. (2013). The mindfulness and acceptance workbook for social anxiety and shyness. Oakland, CA: New Harbinger Publications, Inc.

    BACKGROUND
  • Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98-105. doi: 10.1016/j.jbtep.2008.04.004. Epub 2008 Apr 26.

    PMID: 18514614BACKGROUND
  • Fresco DM, Coles ME, Heimberg RG, Liebowitz MR, Hami S, Stein MB, Goetz D. The Liebowitz Social Anxiety Scale: a comparison of the psychometric properties of self-report and clinician-administered formats. Psychol Med. 2001 Aug;31(6):1025-35. doi: 10.1017/s0033291701004056.

    PMID: 11513370BACKGROUND
  • Banks, M. H., Clegg, C. W., Jackson, P. R., Kemp, N. J., Stafford, E. M., & Wall, T. D. (1980). The use of the General Health Questionnaire as an indicator of mental health in occupational studies. Journal of Occupational Psychology, 53, 187-194.

    BACKGROUND
  • Goldberg, D. (1978). Manual of the GHQ. Windsor: NFER.

    BACKGROUND
  • Hahn EA, DeWalt DA, Bode RK, Garcia SF, DeVellis RF, Correia H, Cella D; PROMIS Cooperative Group. New English and Spanish social health measures will facilitate evaluating health determinants. Health Psychol. 2014 May;33(5):490-9. doi: 10.1037/hea0000055. Epub 2014 Jan 20.

    PMID: 24447188BACKGROUND
  • Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the Valuing Questionnaire (VQ). Journal of Contextual Behavioral Science, 3, 164-172. http://doi.org/10.1016/j.jcbs.2014.06.001

    BACKGROUND
  • Herzberg KN, Sheppard SC, Forsyth JP, Crede M, Earleywine M, Eifert GH. The Believability of Anxious Feelings and Thoughts Questionnaire (BAFT): a psychometric evaluation of cognitive fusion in a nonclinical and highly anxious community sample. Psychol Assess. 2012 Dec;24(4):877-91. doi: 10.1037/a0027782. Epub 2012 Apr 9.

    PMID: 22486595BACKGROUND
  • Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.

    PMID: 24411117BACKGROUND
  • Schultz LT, Heimberg RG, Rodebaugh TL, Schneier FR, Liebowitz MR, Telch MJ. The appraisal of social concerns scale: psychometric validation with a clinical sample of patients with social anxiety disorder. Behav Ther. 2006 Dec;37(4):392-405. doi: 10.1016/j.beth.2006.06.001. Epub 2006 Aug 4.

    PMID: 17071216BACKGROUND
  • Telch MJ, Lucas RA, Smits JA, Powers MB, Heimberg R, Hart T. Appraisal of social concerns: a cognitive assessment instrument for social phobia. Depress Anxiety. 2004;19(4):217-24. doi: 10.1002/da.20004.

    PMID: 15274170BACKGROUND
  • Goldin PR, Morrison AS, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of social anxiety, cognitive reappraisal, and mindfulness during an RCT of CBGT versus MBSR for social anxiety disorder. Behav Res Ther. 2017 Oct;97:1-13. doi: 10.1016/j.brat.2017.06.001. Epub 2017 Jun 3.

    PMID: 28654771BACKGROUND

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael Levin, PhD

    Utah State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two active self-help interventions for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 29, 2017

Study Start

September 16, 2017

Primary Completion

January 2, 2019

Study Completion

January 2, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations