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

Social Anxiety Clinical Trial

Official title:

Core Elements of Cognitive Behavioural Therapy in Treating Speech Anxiety in Youth: Facing Fears by Focussing on Behaviour, Body, or Mind?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711513
• Other study ID #: NL60377.042.16
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: May 2019
• Source: University of Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objective: The primary goal of this study is to evaluate which elements add to the effectiveness of current CBT programs. Second, it will be investigated whether the effect of exposure is reduced by the addition of cognitive restructuring and relaxation exercises. In addition, it will be explored how a given element is effective (i.e., mediation), by investigating which dimension of anxiety (approach/avoidance behavior, cognitions or bodily tension) is changed by which specific element, in a group of adolescents with the performance/public speaking subtype of social phobia.

Study design: Randomized Controlled Trial with three parallel groups (intervention versus intervention versus intervention).

Study population: Adolescents aged 12 to 15 years with subclinical or higher levels of the fear of performance/public speaking subtype of social phobia.

Intervention: Adolescents will be randomly assigned to one of the three conditions based on their age, gender and severity of the social phobia. All adolescents will be offered a psycho-education session on anxiety, social phobia and exposure. Following this session either four exposure sessions (condition A) or two exposure session and two additional sessions are offered. The additional session are either two cognitive restructuring sessions (condition B) or two relaxation sessions (condition C). Each session will be given in groups consisting of five to eight participants. Every session will take up to an hour and is implemented by a psychologist assisted by a master student in psychology, who will receive training and supervision by a certified CBT therapist.

Main study parameters/endpoints (see outcome measures paragraph): The main study parameter is level of fear of performance/public speaking symptoms. Secondary study parameters are subjective level of fear, fearful cognitions, bodily tension, avoidance, coping (possible mediator variables), social phobia diagnosis, speech behavior, and self-efficacy. Tertiary study parameters are healthcare costs and quality of life (cost-effectiveness), note: cost-effectiveness is assessed for another study. Other study parameters are social phobia severity, comorbid anxiety and depression, and demographic variables (possible moderator variables); and credibility and expectancy of the treatment, treatment satisfaction, and treatment compliance (treatment characteristics).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Social Anxiety

Intervention

Behavioral:
• Cognitive behavioral therapy
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.

Locations

Country	Name	City	State
Netherlands	CSG Augustinus	Groningen
Netherlands	Gomarus College	Groningen
Netherlands	RSG De Borgen Lindenborg	Leek	Groningen
Netherlands	Greijdanus College	Zwolle	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
University of Groningen	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (9)

Brady EU, Kendall PC. Comorbidity of anxiety and depression in children and adolescents. Psychol Bull. 1992 Mar;111(2):244-55. Review. — View Citation

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. — View Citation

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. — View Citation

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in cost-effectiveness	In addition, cost-effectiveness of the intervention will be assessed by measuring costs and quality of life (effectiveness). Measuring cost-effectiveness is not the primary goal of this research but since this study is part of a larger national project in which cost-effectiveness will also be taken into account, we consider it relevant to state here.; Healthcare costs will be measured by registration of costs in a cost diary based on the Trimbos Institute and Institute of Medical Technology Assessment Questionnaire on Costs Associated with Psychiatric Illness (TiC-P) and PRODISQ.; The EuroQol Questionaire (EQ-5D-Y youth version) will be used to establish quality of life as expressed in quality adjusted life years (QALYs).; Healtcare costs and in quality adjusted life years (QALYs) will be combined to report cost-effectiveness.	At pre-intervention assessment (T1) and 6 weeks after the intervention at follow-up assessment (T8)
Other	Change in severity of the social phobia	• The severity of the social phobia will be rated on a 0-8 interval scale by an independent psychologist on the ADIS-IV (see above). This rating is based on the level of interference, number of symptoms and general impression of the psychologist. A rating of 0, 1, 2, or 3 means no social phobia, 4 or 5 means the social phobia is mild, whereas a rating of 6, 7, or 8 means the social phobia is severe.	at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
Other	Change in comorbid anxiety and depression	• Given the high comorbidity of anxiety and depression in adolescents, comorbid anxiety and depression will be assessed with the Revised Child Anxiety and Depression Scale for Children (RCADS-C) consisting of 47 items. All items are rated on a 4-point interval scale from 'never' to 'always'. The RCADS has good psychometric properties.	at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
Other	Change in treatment credibility and expectancy	• Credibility and expectancy of the treatment are measured by the Credibility and Expectancy Questionnaire (CEQ-C). This questionnaire contains 6 items all rated on a 9-point interval scale. The psychometric properties of the scale have been qualified as good.	at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
Other	Change in treatment satisfaction	• Treatment satisfaction will be measured with the Service Satisfaction Scale for Children (SSS-C). Four items are rated on a 4-point interval scale ranging from 'no, definitely not' to 'yes, definitely'. The psychometric properties of the scale have been qualified as good.	at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
Other	Change in compliance	• Treatment compliance will be measured using a weekly checklist in which the adolescent can state how much time they spent on the homework assignment, rated in minutes.	Weekly during the five intervention weeks (T2, T3, T4, T5, T6), and one week after the last intervention session at post-intervention assessment (T7), and then six weeks later at follow-up assessment (T8)
Primary	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	Change in level of anxiety	• Level of anxiety compromised of subjective level of fear, fearful cognitions, bodily tension, avoidance and coping will be measured by Visual Analogue Scales (VAS) ranging from 0-100 (ratio scale) on which the adolescent rates the following aspects of the goal situation as set in the PE session: Subjective level of fear: 'I am not frightened' (0) - 'I am completely frightened' (100); Fearful cognitions: 'I do not believe this at all' (0) - 'I completely believe this' (100), in which the credibility of the cognition about the feared situation as set in the PE session is rated.; Bodily tension: 'My body feels not tense at all' (0) - 'My body feels completely tense' (100); Avoidance: 'I would never avoid this situation if I could' (0) - 'I would always avoid this situation if I could' (100); Coping: 'I cannot cope with this situation at all when I encounter it' (0) - 'I can completely cope with this situation when I encounter it' (100)	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)
Secondary	Change in social phobia diagnosis	• Social phobia diagnosis in adolescents will be measured with a clinical semi-structured interview using the Anxiety Disorder Interview Schedule for Children (ADIS-IV-C). The study will only include the section of social phobia. All items offer three possible answers: yes, no or other on a nominal scale (which is chosen when the adolescent answers 'I don't know' or 'sometimes'). If the adolescent meets all three criteria for social phobia as set in the ADIS-IV, he or she will receive the social phobia diagnosis. The ADIS-IV has good test-retest reliability and concurrent validity.	at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
Secondary	Change in speech behavior	• Speech behaviour will be measured by three situational Behavioural Approach Tests (BAT) for feared and avoided situations. The test consists of a number of increasingly difficult steps in which adolescents are asked to approach a phobic situation, but are told they can stop the test at any time they wish to do so. During the BAT, individuals are asked to provide "subjective unit of disturbance scale" (SUDS 0-100 ratio scale) ratings immediately after encountering the phobic situation.	at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)
Secondary	Change in self-efficacy	• Self-efficacy will be measured by the Self Efficacy Questionnaire for Children (SEQ-C). This questionnaire contains 24 questions regarding academic, social and emotional self-efficacy. Items are rated on a 5-point interval scale from 'not at all' (1) to 'very well' (5). The SEQ-C is proven to be a valid instrument with sufficient reliability.	at pre-intervention assessment (T1), 6 weeks later at post-intervention assessment (T7), and 6 weeks later at follow-up assessment (T8)