Substance UseSUBMINCT02771886
Evaluation of a Brief Surf the Urge Intervention
A study testing Surf the Urge in people with Substance Use and Deliberate Self-harm, run by Kimberly N Schubert at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Substance Use, Deliberate Self-harm, Trichotillomania
- What is being tested?
- Surf the Urge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Younger than 14
- Older than 24
- Does not endorse experiencing urge, or conducting urge-related behavior engagement, during the past week
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas
Las Vegas, Nevada, 455030
About this study
Official title: Evaluation of a Brief "Surf the Urge" Intervention
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.
Read the 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:
- 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.
- 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).
- 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).
- 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.
- 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.
- Conditions
- Substance Use, Deliberate Self-harm, Trichotillomania, Aggression, Stealing, Eating Pathology
- Being tested
- Surf the Urge
- Keywords
- mindfulness, urges, adolescents, risk behaviors, therapy intervention
- Medical subject headings
- Substance-Related Disorders, Self-Injurious Behavior, Trichotillomania, Aggression, Gambling, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surf the UrgeBehavioural
Also called Surfing 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.
| Study group | Role | What they receive |
|---|---|---|
| 2-week intervention group | Active comparator | 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. Receives: Behavioral: Surf the Urge |
| 4-week intervention group | Active comparator | 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. Receives: Behavioral: Surf the Urge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mindfulness skills from baseline at 6 weeks
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.
Measured: week 1 of study duration; week 6 of study duration
Change of urge feelings from baseline at 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.
Measured: each week of the study's duration or once a week for 6 weeks
Change in urge-related behavior engagement from baseline at 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.
Measured: each week of the study's duration or once a week for 6 weeks
Client Satisfaction Questionnaire-8
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).
Measured: week 6 of study duration
Secondary outcomes (3)
Demographics
age, gender, ethnicity, receiving intervention services elsewhere, relationship status
Measured: week 1 of study duration
The Multidimensional Personality Questionnaire-Brief Form
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.
Measured: week 1 of study duration
Change in mental health symptoms from baseline at 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.
Measured: each week of study's duration or once a week for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly N Schubert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kimberly N Schubert, University of Nevada, Las Vegas
- Investigators
- Stephen Benning, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771886
- Sponsor's protocol ID
- SUBMI-2015
- Acronym
- SUBMI
- Status last verified
- Apr 2017
- First submitted
- 17 Dec 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Brief "Surf the Urge" Intervention
- ClinicalTrials.gov ID
- NCT02771886
- Acronym / sponsor ID
- SUBMI / SUBMI-2015
- Conditions
- Substance Use, Deliberate Self-harm, Trichotillomania, Aggression, Stealing, Eating Pathology
- Keywords
- mindfulness, urges, adolescents, risk behaviors, therapy intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kimberly N SchubertUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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).
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-week intervention group | Active comparator | Behavioral: Surf the UrgeThe "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. |
| 4-week intervention group | Active comparator | Behavioral: Surf the UrgeThe "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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Younger than 14
- Older than 24
- Does not endorse experiencing urge, or conducting urge-related behavior engagement, during the past week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surf the UrgeAlso: Surfing the UrgeThe 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. | Behavioural | 2-week intervention group, 4-week intervention group |
Primary outcome
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.
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.
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.
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).
3 secondary outcomes
Demographics
Time frame: week 1 of study duration
The Multidimensional Personality Questionnaire-Brief Form
Time frame: week 1 of study duration
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Benning, PhD principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surf the Urge in people with Substance Use and Deliberate Self-harm, run by Kimberly N Schubert at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mindfulness skills from baseline at 6 weeks (time frame: week 1 of study duration; week 6 of study duration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.