Facing Fears by Focussing on Behaviour, Body, or Mind?

NCT03711513 | Completed

• 1 other identifier: NL60377.042.16
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 4

Brief Summary

Anxiety problems are a major concern of youth mental health given that the prevalence of anxiety disorders in Dutch adolescents aged 12 to 18 is approximately 10 percent. In this group, social phobia like speech or performance anxiety are among the most common. Intervention programs based on the principles of exposure-based Cognitive Behavioral Therapy (CBT) have proven to be the most effective and most applied in therapy for social anxiety among adolescents. Thus far, research has mainly focused on effectiveness of "intervention packages" consisting of multiple CBT elements (i.e., exposure plus cognitive restructuring and relaxation exercises). The most common CBT element in current intervention packages for anxiety in youth is exposure, which is often only applied after providing the child with cognitive restructuring (CR) and relaxation exercises (RE) as preparation for exposure. However, although most empirical evidence supports the value of the use of exposure, there is hardly empirical evidence for the additional value of CR or RE. In addition, it is unclear whether the combination of these elements with exposure is counterproductive compared to the use of exposure only. After all, without lengthening the treatment, the addition of CR and/or RE will leave the therapist and child with less time to spend on exposure exercises.This study proposes to evaluate the effectiveness of these three different types of CBT-elements in the treatment of speech/performance anxiety among adolescents.

Conditions

Social Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in fear of performance/public speaking symptoms

  • Fear of performance/public speaking symptoms will be measured by the Public Performance Factor (PPF) scale of the Social Phobia and Anxiety Inventory for Children (SPAI-C), which evaluates the somatic, cognitive and behavioural aspects of social phobia in children. This questionnaire contains 26 questions all rated on a 3-point interval scale. The PPF scale consists of 7 items. The SPAI-C has sufficient test-retest reliability and good construct, convergent and discriminative validity.

  At screening (T0), 6 weeks later at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)

Secondary Outcomes (4)

• Change in level of anxiety

  Weekly during the five intervention weeks (T2, T3, T4, T5, T6), and one week after the last intervention sessies at post-intervention assessment (T7), and then six weeks later at follow-up assessment (T8)

• Change in social phobia diagnosis

  at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)

• Change in speech behavior

  at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)

• Change in self-efficacy

  at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)

Other Outcomes (6)

• Change in cost-effectiveness

  At pre-intervention assessment (T1) and 6 weeks after the intervention at follow-up assessment (T8)

• Change in severity of the social phobia

  at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)

• Change in comorbid anxiety and depression

  at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)

Study Arms (3)

Exposure only

EXPERIMENTAL

Psycho-education (PE) (plus homework) + 4 x Exposure (EX) (plus homework): 20 participants will receive four exposure group sessions after the psycho-education session. In the four sessions they will move up in their fear hierarchy by practicing public speaking/performance tasks.

Behavioral: Cognitive behavioral therapy

Cognitive restructuring plus exposure

EXPERIMENTAL

PE (plus homework) + Cognitive Restructuring (CR) (plus homework) + CR (plus homework) + EX (plus homework) + EX: 20 participants will receive two cognitive restructuring group sessions after the psycho-education session. In these two session they will practice identifying dysfunctional cognitions and formulating more functional (alternative/helping) cognitions. After the cognitive sessions they will receive two exposure group sessions. In these two sessions they will move up in their fear hierarchy by practicing public speaking/performance tasks.

Behavioral: Cognitive behavioral therapy

Relaxation plus exposure

EXPERIMENTAL

PE (plus homework) + Relaxation (RE) (plus homework) + RE (plus homework) + EX (plus homework) + EX: 20 participants will receive two relaxation exercises group sessions after the psycho-education session. In these two session they will practice muscle relaxation and breathing exercises. After the relaxation sessions they will receive two exposure group sessions. In these two sessions they will move up in their fear hierarchy by practicing public speaking/performance tasks.

Behavioral: Cognitive behavioral therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

All conditions start with a psycho-education session (PE). Subsequently, participants in condition A follow four exposure sessions (EX). Participants in condition B follow two cognitive restructuring (CR) followed by two exposure sessions. Participants in condition C follow two relaxation exercises sessions (RE) followed by two exposure sessions. All sessions will take place at their school in a group of five to eight adolescents (week 9,10,11,12,13,14). The sessions will be provided by a psychologist who receives training and supervision by a certified CBT therapist. The psychologist is assisted by a master student in psychology.

Cognitive restructuring plus exposure; Exposure only; Relaxation plus exposure

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents are aged between 12-15 years old
• Sufficient knowledge of the Dutch language
• Subclinical or higher level of the fear of performance/public speaking subtype of social phobia (SPAI-C PPF score \>6 (MEAN + 1 SD); Beidel, 1996)

You may not qualify if:

• Absence of permission of legal guardian(s)
• Currently in treatment or receiving medication for anxiety
• Received CBT for anxiety in the past 12 months
• Past or current diagnosis of ASS/ADHD
• Different or more urgent request for help
• (Risk of) suicidality or suicidal ideation (as evidenced by checking CDI item 9 score \>1 and confirmation in the ADIS interview)

Sponsors & Collaborators

• University of Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (4)

Greijdanus College

Zwolle, Overijssel, 8017 CB, Netherlands

Location

RSG De Borgen Lindenborg

Leek, Provincie Groningen, 9351 HC, Netherlands

Location

Gomarus College

Groningen, 9721 LX, Netherlands

Location

CSG Augustinus

Groningen, 9726 GP, Netherlands

Location

Related Publications (9)

• Reynolds S, Wilson C, Austin J, Hooper L. Effects of psychotherapy for anxiety in children and adolescents: a meta-analytic review. Clin Psychol Rev. 2012 Jun;32(4):251-62. doi: 10.1016/j.cpr.2012.01.005. Epub 2012 Feb 13.

  PMID: 22459788 BACKGROUND

• Storch EA, Masia-Warner C, Dent HC, Roberti JW, Fisher PH. Psychometric evaluation of the Social Anxiety Scale for Adolescents and the Social Phobia and Anxiety Inventory for Children: construct validity and normative data. J Anxiety Disord. 2004;18(5):665-79. doi: 10.1016/j.janxdis.2003.09.002.

  PMID: 15275945 BACKGROUND

• Silverman WK, Saavedra LM, Pina AA. Test-retest reliability of anxiety symptoms and diagnoses with the Anxiety Disorders Interview Schedule for DSM-IV: child and parent versions. J Am Acad Child Adolesc Psychiatry. 2001 Aug;40(8):937-44. doi: 10.1097/00004583-200108000-00016.

  PMID: 11501694 BACKGROUND

• Wood JJ, Piacentini JC, Bergman RL, McCracken J, Barrios V. Concurrent validity of the anxiety disorders section of the Anxiety Disorders Interview Schedule for DSM-IV: child and parent versions. J Clin Child Adolesc Psychol. 2002 Sep;31(3):335-42. doi: 10.1207/S15374424JCCP3103_05.

  PMID: 12149971 BACKGROUND

• Koopmanschap MA. PRODISQ: a modular questionnaire on productivity and disease for economic evaluation studies. Expert Rev Pharmacoecon Outcomes Res. 2005 Feb;5(1):23-8. doi: 10.1586/14737167.5.1.23.

  PMID: 19807557 BACKGROUND

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

• Brady EU, Kendall PC. Comorbidity of anxiety and depression in children and adolescents. Psychol Bull. 1992 Mar;111(2):244-55. doi: 10.1037/0033-2909.111.2.244.

  PMID: 1557475 BACKGROUND

• Chorpita BF, Moffitt CE, Gray J. Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behav Res Ther. 2005 Mar;43(3):309-22. doi: 10.1016/j.brat.2004.02.004.

  PMID: 15680928 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Peter de jong, Prof

  University of Groningen

  STUDY CHAIR

• Maaike Nauta, Prof

  University of Groningen

  STUDY DIRECTOR

• Miriam Lommen, Dr

  University of Groningen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: October 18, 2018
• Study Start: November 6, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

NL (4)