Facing Fears In-session or Out-session?

University of Groningen

Status: Completed

Conditions: Specific Phobia

Treatments: Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03688360

NL59889.042.16

Details and patient eligibility

About

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.

Full 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).

Enrollment: 55 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups

Therapist-guided in-session

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Self-guided out-session

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Parent-guided out-session

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy