Facing Fears In-session or Out-session?

NCT03688360 | Completed

• 1 other identifier: NL59889.042.16
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Specific Phobia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in level of anxiety (Subjective level of fear, Fearful cognitions, Bodily tension, Avoidance and Coping)

  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)

• Change in approach behaviour towards phobic stimulus (Time and distance)

  At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

• Change in self-efficacy (Academic, Social and Emotional)

  At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

Other Outcomes (9)

• Cost-effectiveness (Healthcare costs and In quality adjusted life years)

  At pre-intervention assessment (T1) and eight weeks later at follow-up assessment (T6)

• Change in specific phobia diagnosis (Interference, number of symptoms and general impression of the psychologist)

  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)

• Change in comorbid anxiety and depression symptoms

  At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)

Study Arms (3)

Therapist-guided in-session

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy

Self-guided out-session

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy

Parent-guided out-session

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy 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.

Parent-guided out-session; Self-guided out-session; Therapist-guided in-session

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Accare Universitair Centrum voor Kinder en Jeugdpsychiatrie

Groningen, 9713 GZ, Netherlands

Location

Related Publications (10)

• 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

• 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.

  PMID: 18410984 BACKGROUND

• 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.

  PMID: 26246900 BACKGROUND

• 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.

  PMID: 526242 BACKGROUND

• 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.

  PMID: 37832323 DERIVED

MeSH Terms

Conditions

Phobia, Specific

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: PhD Student

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: September 28, 2018
• Study Start: October 4, 2017
• Primary Completion: February 4, 2020
• Study Completion: February 4, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Locations

NL (1)