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Facing Fears in Big or Smalls Steps?

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ClinicalTrials.gov Identifier: NCT03688373
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : April 13, 2020
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Rachel de Jong, University of Groningen

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.

Condition or disease Intervention/treatment Phase
Specific Phobia Behavioral: Cognitive Behavioral Therapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Exposure in the Treatment of Anxiety in Youth: Facing Fears in Big or Smalls Steps?
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : October 4, 2020
Estimated Study Completion Date : October 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias

Arm Intervention/treatment
Experimental: 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.
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 (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.

Experimental: 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.
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 (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.




Primary Outcome Measures :
  1. Change in specific phobia severity (Interference, number of symptoms and general impression of the psychologist) [ Time Frame: Time Frame: 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) ]
    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 the different conditions. The ADIS-IV has good test-retest reliability and concurrent validity.


Secondary Outcome Measures :
  1. Change in level of anxiety (Subjective level of fear, Fearful cognitions, Bodily tension, Avoidance and Coping) [ Time Frame: Time Frame: In the first treatment session (T2), one week later in the second treatment session (T3), one week later in the third treatment session (T4), and one week later at post-intervention (T5), and four weeks later at follow-up assessment (T6) ]

    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)

  2. Change in approach behaviour (Time and Distance) [ Time Frame: Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and four weeks later at follow-up assessment (T6) ]
    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.

  3. Change in self-efficacy (Academic, Social and Emotional) [ Time Frame: Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and four weeks later at follow-up assessment (T6) ]
    Self-efficacy will be measured by the Self Efficacy Questionnaire for Children (SEQ-C). 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.


Other Outcome Measures:
  1. Cost-effectiveness (Healthcare costs and In quality adjusted life years) [ Time Frame: Time Frame: At pre-intervention assessment (T1) and eight weeks later at follow-up assessment (T6) ]

    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 are combined to report cost-effectiveness.


  2. Change in specific phobia diagnosis (Interference, number of symptoms and general impression of the psychologist) [ Time Frame: Time Frame: 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) ]
    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.

  3. Comorbid anxiety and depression symptoms [ Time Frame: Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6) ]
    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 (RCADSC/ 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 (Chorpita, Moffitt, & Gray, 2005) and the SCAS (Whiteside & Brown, 2008) have good psychometric properties, and are combined into the RCADSCAS for this study.

  4. Change in in-session fear before and after each exposure exercise [ Time Frame: During the second (T3) and the third (T4) treatment session ]
    In-session fear is measured before and after every in-session exposure step, by asking the adolescent to provide "subjective unit of disturbance scale" (SUDS) ratings on a ratio scale 0-100 immediately before and after a new step in encountering the phobic object or situation.

  5. In-session harm expectancy before and after each exposure exercise [ Time Frame: During the second (T3) and the third (T4) treatment session ]
    In-session harm expectancy is measured before and after every in-session exposure step. Before every exposure step the adolescent is asked: a) 'What are you most worried will happen?', b) 'On a (ratio) scale 0-100, how likely does this seem?, and c) 'On a (ratio) scale 0-100, how bad would it be if the thing you are most worried about will occur?'. After every exposure step the adolescent is reminded of their worry and asked: a) 'On a (ratio) scale 0-100, how likely does it seem this would happen if we would repeat this step?', and b) 'On a (ratio) scale 0-100, how bad would it be if the thing you are most worried about will occur?'.

  6. Change in treatment credibility and expectancy of the treatment [ Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6) ]
    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.

  7. Change in treatment satisfaction during and after treatment [ Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6) ]
    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.

  8. Therapeutic alliance during the treatment [ Time Frame: One week after the last intervention week, at post-intervention assessment (T5) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688373


Contacts
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Contact: Rachel de Jong, MSc +31503637607 r.de.jong@rug.nl
Contact: Maaike Nauta, Prof +31503636450 m.h.nauta@rug.nl

Locations
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Netherlands
Accare Drachten Recruiting
Drachten, Friesland, Netherlands, 9203 EG
Contact: Rachel de Jong, MSc         
Accare Leeuwarden Recruiting
Leeuwarden, Friesland, Netherlands, 8933 AJ
Contact: Fenna Heijnen, MSc         
Accare Universitair Centrum voor Kinder en Jeugdpsychiatrie Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Maaike Nauta, Prof         
Sponsors and Collaborators
University of Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Study Chair: Peter de Jong, Prof University of Groningen
Study Director: Maaike Nauta, Prof University of Groningen
Study Director: Miriam Lommen, Dr University of Groningen
Publications:

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Responsible Party: Rachel de Jong, PhD Student, University of Groningen
ClinicalTrials.gov Identifier: NCT03688373    
Other Study ID Numbers: NL59986.042.16
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No