Facing Fears In-session or Out-session?

Specific Phobia Clinical Trial

Official title:

Optimizing Exposure in the Treatment of Anxiety in Youth: Facing Fears In-session or Out-session?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688360
• Other study ID #: NL59889.042.16
• Status: Completed
• Phase: N/A
• Start date: October 4, 2017
• Est. completion date: February 4, 2020

Study information

• Verified date: April 2020
• 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 children aged up to 12 is approximately 4 to 8 percent. In this group, specific phobias are among the most common. Cognitive Behavioral Therapy (CBT) with exposure as its key ingredient, takes a prominent place in national guidelines for the treatment of anxiety disorders. These guidelines are based on empirical support that exposure is effective in the treatment of specific phobia. Yet, despite the empirical evidence of its efficacy, a gap between theory and practice remains, with exposure-based CBT being underused in clinical practice. For example, a recent Dutch survey found that exposure was mostly practiced outside the formal therapy sessions as homework assignment. It is questionable whether this is effective, given that it might be hard for children to do these assignments independently (e.g., without the help of a therapist or their parents). This study therefore proposes to evaluate the effectiveness of different degrees of therapist and parent involvement during exposure, comparing therapist supported exposure with self-supported exposure with and without the use of parents as co-therapists.

Description:

Objective: The primary goal of this study is to evaluate whether therapist supported in-session exposure exercises are more effective than individual out-session exposure exercises, or parent supported out-session exposure exercises. The secondary goal is to find child, parent and therapist factors that possibly relate to the effectiveness of the exposure exercises.

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

Study population: Children aged 8 to 12 years with a specific phobia of the animal/situational subtype

Intervention (if applicable): The intervention will be designed as a CBT, a therapy which has proven to be effective in treating specific phobia. The intervention consists of three individual sessions, each up to 60 minutes long. Each condition starts with a psycho-education session on specific phobias and exposure. In the following two sessions, that differ per condition, either two therapist-guided in-session exposure exercises or two self-guided out-session exposure sessions are offered. In the out-session exposure sessions the child conducts the exposure exercises either with or without the help of a parent. The intervention will be provided by an experienced mental health professional.

Main study parameters/endpoints (see outcome measures paragraph): The main study parameter is specific phobia severity. Secondary study parameters are subjective level of fear, fearful cognitions, bodily tension, avoidance, coping (possible mediator variables), approach 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 specific phobiadiagnosis, general comorbidity, comorbid anxiety and depression, parental fear, parental modelling behaviors, and demographic variables (possible moderator variables); and credibility and expectancy of the treatment, treatment compliance, treatment satisfaction, and therapeutic alliance (treatment characteristics).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Aged between 8-12 years old and in primary school

• Sufficient knowledge of the Dutch language

• Meeting the criteria of a specific phobia of the situational or animal subtype

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

• Specific phobia that do not fall under the situational or animal subtype, for example:

• Aerophobia: fear of flying

• Emetophobia: fear of vomiting

• Hemophobia: fear of blood

• Hosophobia: fear of infection

• Astraphobia: fear of lightning

• Different and more urgent request for help

• (Risk of) suicidality, psychosis or domestic violence

Related Conditions & MeSH terms

• Specific Phobia

Intervention

Behavioral:
• Cognitive Behavioral Therapy
. Each intervention will contain a 60-minute psycho-education session (PE) and two 60-minute exposure sessions (EX), conducted by a mental health professional together with a master student in psychology, who are both weekly supervised by a CBT certified psychologist. In the first (PE) session, participants learn about anxiety, specific phobias and exposure. During this session they will create a fear hierarchy, formulate their cognition about the feared object or situation and determine what they want to achieve during treatment (e.g. goal situation). The next two sessions consist of exposure exercises.

Locations

Country	Name	City	State
Netherlands	Accare Universitair Centrum voor Kinder en Jeugdpsychiatrie	Groningen

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

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

Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. — View Citation

Sars D, van Minnen A. On the use of exposure therapy in the treatment of anxiety disorders: a survey among cognitive behavioural therapists in the Netherlands. BMC Psychol. 2015 Aug 5;3:26. doi: 10.1186/s40359-015-0083-2. eCollection 2015. — 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

Wolitzky-Taylor KB, Horowitz JD, Powers MB, Telch MJ. Psychological approaches in the treatment of specific phobias: a meta-analysis. Clin Psychol Rev. 2008 Jul;28(6):1021-37. doi: 10.1016/j.cpr.2008.02.007. Epub 2008 Mar 7. — 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	Cost-effectiveness (Healthcare costs and In quality adjusted life years)	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).; Healthcare costs and in quality adjusted life years will be combined to report cost-effectiveness.	At pre-intervention assessment (T1) and eight weeks later at follow-up assessment (T6)
Other	Change in specific phobia diagnosis (Interference, number of symptoms and general impression of the psychologist)	Specific phobia diagnosis will be assessed with the ADIS IV (see above). 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 four criteria for specific phobia as set in the ADIS-IV, he or she can participate in the study.	At intake (T0), four weeks later at pre-intervention assessment (T1), another four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Other	Change in comorbid anxiety and depression symptoms	Given the high comorbidity of anxiety and depression in children, comorbid anxiety and depression will be assessed with the Revised Child Anxiety and Depression Scale for Children and Parents (RCADS-C/P) consisting of 47 items and the Phobia section of the Spence Children's Anxiety Scale for Children and Parents (SCAS-C/P) consisting of 9 items. All items are rated on a 4-point interval scale from 'never' to 'always'. Both the RCADS and the SCAS have good psychometric properties and are combined into the RCADSCAS for this study.	At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Other	Change in parental fear (Phobia, Avoidance and Associated anxiety)	Parental fear will be measured by the Fear Questionnaire (FQ). This questionnaire contains 24 questions regarding phobia, avoidance, and associated anxiety. The specific phobia of the child will be added idiosyncratically for each family. Items are rated on an 8-point interval scale from 'no fear' to 'in panic'. Reliability and construct validity have proven to be sufficient.	At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Other	Change in parental modelling behaviours (Modelling and Reassurance)	Parental modelling behaviours will be measured by the modelling/reassurance scale of the Child Development Questionnaire (CDQ). This scale contains 18 items all rated on a 5-point interval scale from 'never' to 'always'.	At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Other	Change in treatment credibility and expectancy of the treatment	• Credibility and expectancy of the treatment are measured by the Credibility and Expectancy Questionnaire (CEQ-C/P). 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), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Other	Change in treatment satisfaction	• Treatment satisfaction will be measured with the Service Satisfaction Scale (SSS). 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), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Other	Change in compliance to the treatment	Treatment compliance will be measured using a weekly checklist in which the child and parent can state how much time they spent on the out-session exposure homework assignment, rated in minutes.	During the second intervention week (T3), and the third intervention week (T4), and one week later at post-intervention assessment (T5), and four weeks later at follow-up assessment (T6)]
Other	Therapeutic alliance in the treatment	Therapeutic alliance is measured by the Therapeutic Alliance Scale for Children and Parents (TAS-C/P). Both parts consist of 12 items rated on a 4-point interval scale. The psychometric properties of the scale have been qualified as good.	One week after the last intervention week, at post-intervention assessment (T5)
Primary	Change in specific phobia severity (Interference, number of symptoms and general impression of the psychologist)	Specific phobia severity in children will be measured with a clinical semi-structured interview using the Anxiety Disorder Interview Schedule for Children and Parents (ADIS-IV-C/P). The study will only include the section of specific phobia. Severity of the specific 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 0, 1, 2 or 3 is labelled as no specific phobia, a rating of 4 or 5 is labelled as a mild specific phobia, whereas a rating of 6, 7 or 8 means the specific phobia is labelled as severe. This rating is used to randomize the participants to one of the conditions. The ADIS-IV has good test-retest reliability and concurrent validity.	At intake (T0), four weeks later at pre-intervention assessment (T1), another four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Secondary	Change in level of anxiety (Subjective level of fear, Fearful cognitions, Bodily tension, Avoidance and Coping)	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 child rates the following aspects of the goal situation as set in the PE session: Subjective level of fear: 'Not frightened at all' (0) - '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 object or 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/object if I could' (0) - 'I would always avoid this situation/object if I could' (100); Coping: 'I cannot cope with this situation/object at all when I encounter it' (0) - 'I can completely cope with this situation/object when I encounter it' (100)	During the first intervention week (T2), the second week (T3), and the third week (T4), and one week later at post-intervention assessment (T5), and four weeks later at follow-up assessment (T6)
Secondary	Change in approach behaviour towards phobic stimulus (Time and distance)	Approach behaviour will be measured by three situational Behavioural Approach Tests (BAT) for feared and avoided objects or situations. The test consists of a number of increasingly difficult steps in which children are asked to approach a phobic object or 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 animal or situation.	At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
Secondary	Change in self-efficacy (Academic, Social and Emotional)	Self-efficacy will be measured by the Self Efficacy Questionnaire for Children (SEQ-C; Muris, 2001). 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 (Muris, 2001).	At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)