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

NCT ID: NCT03711513

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-06
• Study Completion Date: 2019-01-31

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.

Detailed 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).

Conditions

Social Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exposure only

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.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: 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.

Relaxation plus exposure

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.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

University of Groningen

OTHER

Sponsor Role: lead

Responsible Party

Rachel de Jong

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter de jong, Prof

Role: STUDY_CHAIR

University of Groningen

Maaike Nauta, Prof

Role: STUDY_DIRECTOR

University of Groningen

Miriam Lommen, Dr

Role: STUDY_DIRECTOR

University of Groningen

Locations

Greijdanus College

Zwolle, Overijssel, Netherlands

RSG De Borgen Lindenborg

Leek, Provincie Groningen, Netherlands

Gomarus College

Groningen, , Netherlands

CSG Augustinus

Groningen, , Netherlands

Countries

Netherlands

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Other Identifiers

NL60377.042.16

Identifier Type: -

Identifier Source: org_study_id