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Evaluation of a Brief Surf the Urge Intervention (SUBMI)

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ClinicalTrials.gov Identifier: NCT02771886
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Kimberly N Schubert, University of Nevada, Las Vegas

Brief Summary:
The purpose of this study is to evaluate the effectiveness of a brief "Surf the Urge" intervention to reduce adolescent and young adult (i.e., 14 to 24 years old) urge-related behaviors. These behaviors will include, but not be limited to, substance use, deliberate self-harm, aggressive behavior, pulling out hair, and loosing control when eating.The intervention will utilize mindfulness skills (i.e., awareness, acceptance, nonjudgment) to assist in reducing these risky behaviors.

Condition or disease Intervention/treatment Phase
Substance Use Deliberate Self-harm Trichotillomania Aggression Stealing Eating Pathology Gambling Behavioral: Surf the Urge Not Applicable

Detailed Description:

Empirical research has not specifically examined the effectiveness of the Surf the Urge intervention with an adolescent and young adult sample. Additionally, the value of this intervention with urge-related behaviors besides smoking (e.g., substance use, purging,, deliberate self-harm) is unclear. The current study will examine the efficacy of the Surf the Urge intervention in a sample of 14 to 24-year-olds who engage in a diverse array of urge-related behaviors. To aid participants in reducing their urge-related behavior, and coping with urges, the investigators will cue urges during the intervention by utilizing a cue exposure script. Urge-related behaviors to examine include alcohol use, drug use, tobacco use, deliberate self-harm, and self-induced vomiting. Additionally, only participants who experience urges or engage in the urge-related behavior a minimum of one time per week will be included. If participants report engaging in several urge-related behaviors, or experiencing varying urges, throughout a one-week period, they will be prompted to report the urge engaged in, or experienced, more frequently.purging, restrictive eating, violent actions (e.g., punching someone), gambling, stealing, trichotillomania, etc.

Additionally, the duration of the study will consist of a 6-week time-period, with the intervention occurring at either 2- or 4-weeks, creating a mixed-design model. This model will require fewer participants and allow the evaluation of individual differences related to intervention effectiveness. Additionally, this will enable the comparison of whether participants who were provided with the intervention at 2-weeks, compared to 4-weeks, were able to reduce their urge-related behaviors earlier. It is hypothesized that:

  1. The Surf the Urge mindfulness intervention will decrease various urge-related behaviors (e.g., substance use, deliberate self-harm); however, this intervention will not directly affect a participant's self reported urge levels. Furthermore, individuals in the 2- week intervention group will reduce their urge-related behaviors sooner than those in the 4-week intervention group.
  2. Participants who score higher on a self-report mindfulness questionnaire (Five Facet Mindfulness Questionnaire) will show greater reductions in their urge-related behaviors (e.g., substance use, deliberate self-harm).
  3. Participants who demonstrate the greatest change from their pre- to post- assessment mindfulness self-report scores (Five Facet Mindfulness Questionnaire) will show the greatest changes in urge-related behaviors. They will also rate the Surf the Urge intervention as more satisfying (Client Satisfaction Questionnaire-8).
  4. Participants who rate the Surf the Urge intervention as more satisfying (Client Satisfaction Questionnaire-8) will demonstrate a greater reduction in their urge-related behaviors.
  5. There will be a 95% adherence rate to both the cue exposure and Surf the Urge protocols demonstrating proper implementation. When assessing intervention integrity, there will be no statistically significant difference in adherence between trained therapists and myself.

This study will provide information on the effectiveness of a brief mindfulness intervention to reduce various urge-related behaviors in a high-risk population (i.e., adolescents). It will provide additional information on a growingly popular intervention technique in a newly studied population and with newly examined problem behaviors. These results may lead to further information on the effectiveness of mindfulness interventions with adolescents and have implications for future treatment modalities. Additionally, it will also provide information on the characteristics of individuals who may be more responsive to briefer urge-behavior reduction interventions.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Brief "Surf the Urge" Intervention
Actual Study Start Date : February 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Arm Intervention/treatment
Active Comparator: 2-week intervention group
The "Surf the Urge" intervention will be provided to the participant during his or her 2nd week in the study. The duration of the study will be 6 weeks.
Behavioral: Surf the Urge

The intervention teaches clients to be aware of and accept their feelings, thoughts, and sensations in a non-judgmental manner. Clients learn to remain present within the moment, become aware of their urges, and focus on accepting thoughts and feelings rather than suppressing or changing them. It utilizes visual imagery to assist clients in utilizing more acceptance skills; the client imagines his urges as waves within the ocean and then imagines surfing the waves.

Some interventionists also provide psychoeducation. Clients learn that urges will not last forever; clients are also taught information about reinforcing urges. The interventionist explains that if clients do not reinforce urges (e.g., do not smoke when an urge to smoke arises) they will eventual subside; however, reinforcing urges (smoke when an urge to smoke arises) will produce stronger urges. Emphasis is placed on the belief that clients have the choice to refrain from engaging in urge-related behaviors.

Other Name: Surfing the Urge

Active Comparator: 4-week intervention group
The "Surf the Urge" intervention will be provided to the participant during his or her 4th week in the study. The duration of the study will be 6 weeks.
Behavioral: Surf the Urge

The intervention teaches clients to be aware of and accept their feelings, thoughts, and sensations in a non-judgmental manner. Clients learn to remain present within the moment, become aware of their urges, and focus on accepting thoughts and feelings rather than suppressing or changing them. It utilizes visual imagery to assist clients in utilizing more acceptance skills; the client imagines his urges as waves within the ocean and then imagines surfing the waves.

Some interventionists also provide psychoeducation. Clients learn that urges will not last forever; clients are also taught information about reinforcing urges. The interventionist explains that if clients do not reinforce urges (e.g., do not smoke when an urge to smoke arises) they will eventual subside; however, reinforcing urges (smoke when an urge to smoke arises) will produce stronger urges. Emphasis is placed on the belief that clients have the choice to refrain from engaging in urge-related behaviors.

Other Name: Surfing the Urge




Primary Outcome Measures :
  1. Change of mindfulness skills from baseline at 6 weeks [ Time Frame: week 1 of study duration; week 6 of study duration ]
    Five Facet Mindfulness Questionnaire. This self-report analysis of trait mindfulness consists of 39 items based on a 5-point Likert scales, ranging from 1 (Never or Very Rarely True) to 5 (Very Often or Always True). Questions assess five factors of mindfulness, including observing, describing, acting with awareness, non-judging of inner experiences, and non-reactivity to inner experiences.

  2. Change of urge feelings from baseline at 6 weeks [ Time Frame: each week of the study's duration or once a week for 6 weeks ]
    The Urge for Urge-Related Behavior Questionnaire (UURBQ) will assess urges for urge-related behavior. Modifying two widely used valid and reliable measures will create this measure. These measures include the extensively utilized Alcohol Urge Questionnaire (AUQ) and Cocaine Craving Questionnaire (CCQ).The UURBQ will leave "a drink" and "cocaine/coke" blank. This will allow me to fill in the blank with the necessary urge-related behavior (e.g., alcohol, illicit substance, cutting) for each participant assessed. There will be 8 items included within this measure. A slight modification of this measure's response scale will occur. Rather than a check mark along a line with a 0 (Strongly Agree) to 100 (Strongly Disagree) based on the AUQ and CCQ, responses will be based on a 7-point Likert Scales ranging from 0 (Strongly Agree) to 7 (Strongly Disagree). This measure will assess urges for numerous urge-related behaviors.

  3. Change in urge-related behavior engagement from baseline at 6 weeks [ Time Frame: each week of the study's duration or once a week for 6 weeks ]
    The Urge-Related Behavior Engagement Questionnaire measure was developed by modifying similar approaches utilized in previous research assessing whether mindfulness interventions reduced an urge-related behavior (e.g., smoking cessation). Participants will report, "How many times have you engaged in [urge-related behavior] during the past week?" I will fill in the blank (i.e., [urge-related behavior]) with the participant's unique urge-related behavior (e.g., alcohol use, illicit drug use, deliberate self-harm) disclosed during the consent procedure. This will ensure that each participant is asked the same question about his or her unique urge-related behavior. Responses will be based on a 6-point Likert scale. The response options will include, 0) not at all, 1) one to two times, 2) three to four times, 3) once per day for all 7 days, 4) more than once per day, but not for all 7 days, 5) more than once per day, on all 7 days.

  4. Client Satisfaction Questionnaire-8 [ Time Frame: week 6 of study duration ]
    This measure consists of 8 items based on a 4-point Likert scales. Each item has a different range 4-point Likert scale response. For example, ranging from 1 (Poor) to 4 (Excellent) or 1(No, Definitely) to 4 (Yes, Definitely).


Secondary Outcome Measures :
  1. Demographics [ Time Frame: week 1 of study duration ]
    age, gender, ethnicity, receiving intervention services elsewhere, relationship status

  2. The Multidimensional Personality Questionnaire-Brief Form [ Time Frame: week 1 of study duration ]
    Self-report measure of personality consists of 155, True-False, items. This measure assesses 11 primary subscales of personality, with 12 items each, an Unlikely Virtues subscale that is 14 items, and 9 additional validity items (i.e., VRIN, TRIN). The subscales include: Wellbeing, Social Potency, Achievement, Social Closeness, Stress Reaction, Alienation, Aggression, Control, Harm Avoidance, Traditionalism, and Absorption.

  3. Change in mental health symptoms from baseline at 6 weeks [ Time Frame: each week of study's duration or once a week for 6 weeks ]
    The Depression, Anxiety, and Stress Scale consists of 21 items based on a 4-point Likert scales, ranging from zero (Never or Did Not Apply to Me at All) to 3 (Almost Always or Applied to Me Very Much, or Most of the Time). This measure assesses wellbeing based on the three primary domains of a person's life: depression, anxiety, and stress; consequently, breaking this assessment into three subscales. Each subscale measures various domains of that construct; for example, the depression scale includes an assessment of dysphoria, hopelessness, and anhedonia.


Other Outcome Measures:
  1. North American Reading Test [ Time Frame: week 1 of study duration ]
    This measure is comprised of a list of 50 words that increase in difficulty as the assessment progresses. The participant is required to read aloud the list and the researcher records the number of errors made. This assessment evaluates the individual's intelligence (i.e., crystallized intelligence) based on his ability to correctly read and pronounce these 50 words.

  2. Change in risk taking perceptions from baseline at 6 weeks [ Time Frame: week 1 of study duration; week 6 of study duration ]
    This Domain Specific Risk Taking Scale consists of 30 items based on three 7-point Likert scales. The first scale asks participants how likely they are to engage in the behavior ranging from 1 (Extremely Unlikely) to 7 (Extremely Likely). The participant is then asked how risky that behavior appears ranging from 1 (Not at all Risky) to 7 (Extremely Risky) and what the benefits are of that behavior from 1 (No Benefits at All) to 7 (Great Benefits). This self-report measure assesses the likelihood that a person will engage in five domains of risk behaviors (i.e., ethical, financial, health and safety, recreational, and social), as well as how risky the person perceives these behaviors to be and what benefits the person perceives will come from these behaviors. The scale is further broken into three subscales including: risk taking, risk perception, and risk benefits. Scores from the risk perception and risk benefits subscales combined to create a risk attitude score.

  3. Change in impulsivity from baseline to 6 weeks [ Time Frame: week 1 of study duration; week 6 of study duration ]
    The UPPS-P Impulsive Behavioral Scale assesses personality characteristics that lead to various impulsive like behaviors (e.g., Sensation Seeking's relationship with Extraversion). This measure consists of 59 items based on a 4-point Likert scales, ranging from 1 (Agree Strongly) to 4 (Disagree Strongly). This measure assesses impulsivity based on dimensions of the Five Factor Model of Personality and includes five sub-scales (i.e., Negative Urgency, Positive Urgency, [lack of] Premeditation, Sensation Seeking, and [lack of] Perseverance).



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between ages 14 and 24 years old
  • Endorses engaging in an urge-related behavior, or experiencing urges for an urge-related behavior, within the past week
  • Currently receiving treatment (or seeking services) at a university mental health clinic at University of Nevada, Las Vegas OR enrolled in a course requiring research participation at University of Nevada, Las Vegas

Exclusion Criteria:

  • Younger than 14
  • Older than 24
  • Does not endorse experiencing urge, or conducting urge-related behavior engagement, during the past week

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): NCT02771886


Locations
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United States, Nevada
University of Nevada Las Vegas
Las Vegas, Nevada, United States, 455030
Sponsors and Collaborators
Kimberly N Schubert
Investigators
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Principal Investigator: Stephen Benning, PhD University of Nevada, Las Vegas

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Responsible Party: Kimberly N Schubert, Doctoral Practicum Student, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT02771886     History of Changes
Other Study ID Numbers: SUBMI-2015
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If individual participant data is disseminated, it will include only data that has been de-identified. Specifically, only information regarding the effectiveness of the intervention will likely be reported. This could include statistics on urge-related behavior engagement, urge intensity, mental health symptoms, and personality factors.
Keywords provided by Kimberly N Schubert, University of Nevada, Las Vegas:
mindfulness
urges
adolescents
risk behaviors
therapy intervention
Additional relevant MeSH terms:
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Self Mutilation
Aggression
Gambling
Self-Injurious Behavior
Trichotillomania
Behavioral Symptoms
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Wounds and Injuries