Facing Fears In-session or Out-session?

NCT ID: NCT03688360

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-04
• Study Completion Date: 2020-02-04

Brief 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.

Detailed 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).

Conditions

Specific Phobia

Study Design

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

Study Groups

Parent-guided out-session

The participants and one of their parents will prepare and discuss the exposure exercises together with the therapist in the mental health care centre, and conduct 2 x 2 x 45 minutes of exposure exercises together with their parent out of session as a homework assignment.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

. 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.

Therapist-guided in-session

The participants will engage in 2 x 45 minutes of exposure exercises conducted together with the therapist in the mental health care centre. In addition, they will conduct 2 x 45 minutes of exposure exercises by themselves out of session as a homework assignment.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

. 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.

Self-guided out-session

The participants will prepare and discuss the exposure exercises together with the therapist in the mental health care centre, and conduct 2 x 2 x 45 minutes of exposure exercises by themselves out of session as a homework assignment.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

. 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 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

PhD Student

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

Accare Universitair Centrum voor Kinder en Jeugdpsychiatrie

Groningen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 11501694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12149971 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19807557 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10109801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1557475 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15680928 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18410984 (View on PubMed)

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(1):26. doi: 10.1186/s40359-015-0083-2. eCollection 2015.

Reference Type: BACKGROUND

PMID: 26246900 (View on PubMed)

Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.

Reference Type: BACKGROUND

PMID: 526242 (View on PubMed)

de Jong R, Lommen MJJ, van Hout WJPJ, Kuijpers RCWM, Stone L, de Jong P, Nauta MH. Better together? A randomized controlled microtrial comparing different levels of therapist and parental involvement in exposure-based treatment of childhood specific phobia. J Anxiety Disord. 2023 Dec;100:102785. doi: 10.1016/j.janxdis.2023.102785. Epub 2023 Oct 10.

Reference Type: DERIVED

PMID: 37832323 (View on PubMed)

Other Identifiers

NL59889.042.16

Identifier Type: -

Identifier Source: org_study_id