- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03688373
Facing Fears in Big or Smalls Steps?
Optimizing Exposure in the Treatment of Anxiety in Youth: Facing Fears in Big or Smalls Steps?
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Groningen, Netherlands, 9713 GZ
- Accare Universitair Centrum voor Kinder en Jeugdpsychiatrie
-
-
Friesland
-
Drachten, Friesland, Netherlands, 9203 EG
- Accare Drachten
-
Leeuwarden, Friesland, Netherlands, 8933 AJ
- Accare Leeuwarden
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
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)
|
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.
|
Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and four weeks later at follow-up assessment (T6)
|
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.
|
Time Frame: At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and four weeks later at follow-up assessment (T6)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 and in quality adjusted life years are combined to report cost-effectiveness. |
Time Frame: 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)
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.
|
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)
|
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.
|
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)
|
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.
|
During the second (T3) and the third (T4) treatment session
|
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?'.
|
During the second (T3) and the third (T4) treatment session
|
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.
|
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 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.
|
At pre-intervention assessment (T1), four weeks later at post-intervention assessment (T5) and another four weeks later at follow-up assessment (T6)
|
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.
|
One week after the last intervention week, at post-intervention assessment (T5)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Craske MG, Treanor M, Conway CC, Zbozinek T, Vervliet B. Maximizing exposure therapy: an inhibitory learning approach. Behav Res Ther. 2014 Jul;58:10-23. doi: 10.1016/j.brat.2014.04.006. Epub 2014 May 9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hedtke KA, Kendall PC, Tiwari S. Safety-seeking and coping behavior during exposure tasks with anxious youth. J Clin Child Adolesc Psychol. 2009 Jan;38(1):1-15. doi: 10.1080/15374410802581055.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NL59986.042.16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Specific Phobia
-
Johns Hopkins UniversityCompletedSpecific Phobia | Specific Phobia, Animal | Specific Phobia, Situational | Specific Phobia, Natural Environment | Childhood Anxiety DisorderUnited States
-
University of Nevada, RenoCompletedSpecific Phobia | Arachnophobia | Spider PhobiaUnited States
-
University of CyprusYouth Board of CyprusCompleted
-
Norwegian University of Science and TechnologySt. Olavs HospitalWithdrawnSpecific Phobia
-
University of OtagooVRcomeActive, not recruiting
-
University of Texas at AustinTerminated
-
Ruhr University of BochumCompleted
-
University of North Carolina, Chapel HillSociety for a Science of Clinical Psychology; Association for Behavioral and...CompletedSpecific PhobiaUnited States
Clinical Trials on Cognitive Behavioral Therapy
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
University of PittsburghCompletedDepression | Anxiety | Sickle Cell DiseaseUnited States