AngerNCT02001246
Two Anger Management Programs for Teens.
A study testing Real Deal program for Anger Management and Mind-body Bridging (MBB) program in people with Anger and Hostility, run by University of Utah at 2 sites in United States.
Trial summary
The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body bridging (MBB) for anger management compared with the Real Deal anger management program, in helping adolescents control or reduce their anger. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Anger, Hostility, Aggression
- What is being tested?
- Real Deal program for Anger Management and Mind-body Bridging (MBB) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Nov 2016
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- English-speaking
- self-, or allo-referred (parents, peers, court-ordered, school, etc.), based on their propensity for displaying various disruptive, externalizing behaviors, including, anger, hostility, oppositional behavior, and temper outbursts, and as such identified by Youth Services (YS) as a suitable candidate to attend a YS anger management program.
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pain Research Center, Anesthesiology, University of Utah
Salt Lake City, Utah, 84108
Salt Lake County Youth Services
Salt Lake City, Utah, 84115
About this study
Official title: An Exploratory Study of Two Intervention Programs for Anger Management for Teens.
The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body bridging (MBB) for anger management compared with the Real Deal anger management program, in helping adolescents control or reduce their anger.
Read the detailed description
In this pilot randomized-controlled study, we evaluate the effects of MBB as compared with an established anger management program (Real Deal), in helping youth prone to anger develop tools to effectively reduce and control their anger, and potentially reduce other negative emotions and feelings that might be associated with their anger.
- Conditions
- Anger, Hostility, Aggression
- Being tested
- Real Deal program for Anger Management, Mind-body Bridging (MBB) program
- Keywords
- mindfulness, cognitive behavior therapy, awareness, anger, aggression
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Deal program for Anger ManagementBehavioural
Real Deal is an eight week program with sessions one day per week. Each session is approximately 2 hr long.
Mind-body Bridging (MBB) programBehavioural
MBB is an eight week program with sessions one day per week. Each session is approximately 2 hr long.
| Study group | Role | What they receive |
|---|---|---|
| Real Deal program for Anger Management | Active comparator | The Real Deal Anger Management Program is a structured, video-based intervention, which is an easy-to-implement, "plug and play" program that engages students in: (a) cognitive exercises for learning to recognize and correct thinking errors that lead to anger, (b) active practice of social-behavioral skills through role-playing, and (c) participation in progressive muscle relaxation exercises. The program features three training videos that focus on specific skills for controlling conflict. Receives: Behavioral: Real Deal program for Anger Management |
| Mind-body Bridging program | Experimental | The Mind-Body Bridging program for anger management, includes experiential awareness activities, in which individuals learn to become aware of their thoughts, feelings, emotions, and bodily sensations, to help them identify and deal with ruminative and negative thoughts that might be associated with their anger. MBB helps participants use their senses to listen to sounds, and experience visual or tactile input, to calm their minds and relax their bodies. Written 'mapping' exercises enable them to recognize and defuse requirements, which are expectations of how they or the world should be. For the MBB anger management program, participants will be provided with a variety of mapping exercises to identify the source of their anger, and how they can effectively control it. Receives: Behavioral: Mind-body Bridging (MBB) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at Post-assessment in the measure of the Youth Outcomes Questionnaire 30-item (YOQ30)
The Youth Outcome Questionnaire Self-Report 30 (YOQ-30) is a relatively brief (30-item) psychotherapy outcome measure, which considers general symptoms relevant to many youth mental health disorders and social issues. YOQ-30 is appropriate for tracking youth outcomes over time. It can be completed by adolescents between the ages of 12 and 18 and takes about five minutes to complete. It comprises six subscales (Somatic, Social Isolation, Aggression, Conduct Problems, Hyperactivity/Distractibility, and Depression/ Anxiety). A total score can be computed with 0 indicating no symptomatology and 120 indicating severe symptomatology.
Measured: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
Change from baseline at Post-assessment in the measure of the Brief Aggression Questionnaire (BAQ)
The BAQ is a 12-item self-report scale identifying four facets of aggression: Physical Aggression, Verbal Aggression, Anger, and Hostility.
Measured: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
Secondary outcomes (2)
Change from baseline at Post-assessment in the measure of Mindfulness
Five-facet Mindfulness Questionnaire (FFMQ) The FFMQ Short Form (FFMQ-SF) is a 15-item scale assessing five distinct, interpretable facets of mindfulness, including (1) observing, (2) describing, (3) acting with awareness, (4) non-judgement of inner experience, and (5) non-reactivity to inner experience.
Measured: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
Change from baseline at Post-assessment in the measure of Self-compassion
Self-Compassion Scale (SCS) The SCS short form (SCS-SF) is a 12-item scale used to measure self-compassion, an emotionally positive attitude that can protect against the negative consequences of self-judgment, isolation, and rumination (such as in depression). Self-compassion has three main aspects: (1) self-kindness (being kind and understanding toward oneself in instances of pain or failure, rather than being harshly self-critical); (2) common humanity (perceiving one's experiences as part of the larger human experience, rather than seeing them as separating and isolating); and (3) mindfulness (holding painful thoughts and feelings in balanced awareness, rather than over-identifying with them).
Measured: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: We were unable to recruit sufficient numbers of participants to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngerStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshio Nakamura, University of Utah
- Investigators
- Yoshio Nakamura, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001246
- Sponsor's protocol ID
- IRB_00067796
- Status last verified
- Nov 2016
- First submitted
- 27 Nov 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Two Intervention Programs for Anger Management for Teens.
- ClinicalTrials.gov ID
- NCT02001246
- Acronym / sponsor ID
- IRB_00067796
- Conditions
- Anger, Hostility, Aggression
- Keywords
- mindfulness, cognitive behavior therapy, awareness, anger, aggression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were unable to recruit sufficient numbers of participants to complete the study.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Dec 2013 (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 general aim of the proposed pilot study is to evaluate the the efficacy of mind-body bridging (MBB) for anger management compared with the Real Deal anger management program, in helping adolescents control or reduce their anger.
Detailed description
In this pilot randomized-controlled study, we evaluate the effects of MBB as compared with an established anger management program (Real Deal), in helping youth prone to anger develop tools to effectively reduce and control their anger, and potentially reduce other negative emotions and feelings that might be associated with their anger.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Deal program for Anger Management | Active comparator | Behavioral: Real Deal program for Anger ManagementThe Real Deal Anger Management Program is a structured, video-based intervention, which is an easy-to-implement, "plug and play" program that engages students in: (a) cognitive exercises for learning to recognize and correct thinking errors that lead to anger, (b) active practice of social-behavioral skills through role-playing, and (c) participation in progressive muscle relaxation exercises. The program features three training videos that focus on specific skills for controlling conflict. |
| Mind-body Bridging program | Experimental | Behavioral: Mind-body Bridging (MBB) programThe Mind-Body Bridging program for anger management, includes experiential awareness activities, in which individuals learn to become aware of their thoughts, feelings, emotions, and bodily sensations, to help them identify and deal with ruminative and negative thoughts that might be associated with their anger. MBB helps participants use their senses to listen to sounds, and experience visual or tactile input, to calm their minds and relax their bodies. Written 'mapping' exercises enable them to recognize and defuse requirements, which are expectations of how they or the world should be. For the MBB anger management program, participants will be provided with a variety of mapping exercises to identify the source of their anger, and how they can effectively control it. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- English-speaking
- self-, or allo-referred (parents, peers, court-ordered, school, etc.), based on their propensity for displaying various disruptive, externalizing behaviors, including, anger, hostility, oppositional behavior, and temper outbursts, and as such identified by Youth Services (YS) as a suitable candidate to attend a YS anger management program.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Real Deal program for Anger ManagementReal Deal is an eight week program with sessions one day per week. Each session is approximately 2 hr long. | Behavioural | Real Deal program for Anger Management |
| Mind-body Bridging (MBB) programMBB is an eight week program with sessions one day per week. Each session is approximately 2 hr long. | Behavioural | Mind-body Bridging program |
Primary outcome
Change from baseline at Post-assessment in the measure of the Youth Outcomes Questionnaire 30-item (YOQ30)
Time frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
The Youth Outcome Questionnaire Self-Report 30 (YOQ-30) is a relatively brief (30-item) psychotherapy outcome measure, which considers general symptoms relevant to many youth mental health disorders and social issues. YOQ-30 is appropriate for tracking youth outcomes over time. It can be completed by adolescents between the ages of 12 and 18 and takes about five minutes to complete. It comprises six subscales (Somatic, Social Isolation, Aggression, Conduct Problems, Hyperactivity/Distractibility, and Depression/ Anxiety). A total score can be computed with 0 indicating no symptomatology and 120 indicating severe symptomatology.
Change from baseline at Post-assessment in the measure of the Brief Aggression Questionnaire (BAQ)
Time frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
The BAQ is a 12-item self-report scale identifying four facets of aggression: Physical Aggression, Verbal Aggression, Anger, and Hostility.
2 secondary outcomes
Change from baseline at Post-assessment in the measure of Mindfulness
Time frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
Change from baseline at Post-assessment in the measure of Self-compassion
Time frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)
Results and safety
The study was stopped early (reason given: We were unable to recruit sufficient numbers of participants to complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Yoshio Nakamura, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Deal program for Anger Management and Mind-body Bridging (MBB) program in people with Anger and Hostility, run by University of Utah at 2 sites 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: We were unable to recruit sufficient numbers of participants to complete the study.). Results are not available in the source record.
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 from baseline at Post-assessment in the measure of the Youth Outcomes Questionnaire 30-item (YOQ30) (time frame: Baseline (within 1 month of the first session), Mid-assessment (Week 4), Post-Assessment (one week after Week 8)). The study lists 2 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 15 Nov 2016.