Facing Fears in Big or Smalls Steps?

NCT ID: NCT03688373

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-04
• Study Completion Date: 2021-03-04

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, 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. Therapists help phobic adolescents to overcome their fear by gradually, step by step, working their way up from less scary situations to situations that cause a greater deal of anxiety. Although it is clear that exposure is effective, the size of the steps to be taken in this process remains unclear. However, there are multiple reasons to assume that one or the other works best. On the one hand, adolescents will soon gain trust in their own abilities when taking small steps, which enlarges their feeling of self-control (e.g., self-efficacy). On the other hand there is the risk that these small steps might be experienced as safety behavior and avoidance, which is counterproductive to the essence of exposure (i.e., overcoming the fear) and undermines the potential effect. This might result in either a longer treatment or insufficient treatment benefits. Considering this risk, and the fact that confrontation with a feared object or situation in daily life is also not a step-by-step process, this study proposes to evaluate the optimal dosage of exposure, by studying whether exposure in big steps is more effective than exposure in small steps.

Detailed Description

Objective: The primary goal of this study is to evaluate whether exposure in big steps is more effective than a small step-by-step approach. 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 two parallel groups (intervention versus intervention).

Study population: Adolescents aged 12 to 17 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, during which the participants will create a fear hierarchy (from 1 as least fearful to 10 as most fearful). Following this session either two exposure-in-big-steps or two exposure-in-small-steps sessions are offered. In the big steps exposure condition the adolescent moves in three big steps from bottom to top (1-5-10) in their fear hierarchy. In the small steps exposure condition the adolescent moves in many small steps from bottom to top in their fear hierarchy, for example from 1 to 2 to 3 to 4 etc. The intervention will be provided by an experienced mental health professional.

Main study parameters/endpoints (see outcome measures paragraph): The main study parameter isseverity of the specific phobia. Secondary study parameters are out-session fear, fearful cognitions, bodily tension, avoidance, coping, in-session fear, in-session harm expectancy (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, and demographic variables (possible moderator variables); and credibility and expectancy of the treatment, treatment satisfaction, treatment integrity 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

Exposure-in-big-steps

In the big steps exposure sessions the adolescent moves in three a set pace of big steps from bottom to top (1-5-10) in their fear hierarchy. From 0-5 in the first session and from 5-10 in the second session.

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 (1 relating to least fearful and 10 indicating most fearful situation), 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 in either big or small steps.

Exposure-in-small-steps

In the small steps exposure sessions the adolescent moves in a step-by-step pace of their own choice from bottom to top in their fear hierarchy, for example from 1 to 2 to 3 to in the first session and from 4 to 5 to 6 etc. in the second session.

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 (1 relating to least fearful and 10 indicating most fearful situation), 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 in either big or small steps.

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 (1 relating to least fearful and 10 indicating most fearful situation), 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 in either big or small steps.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged between 12-17 years old and in secondary school
• Sufficient knowledge of the Dutch language
• Meeting the criteria of 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: 12 Years
• Maximum Eligible Age: 17 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 Drachten

Drachten, Provincie Friesland, Netherlands

Accare Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Accare Universitair Centrum voor Kinder en Jeugdpsychiatrie

Groningen, , Netherlands

Countries

Netherlands

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Other Identifiers

NL59986.042.16

Identifier Type: -

Identifier Source: org_study_id