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Acceptance and Commitment Therapy for Nonsuicidal Self-injury

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ClinicalTrials.gov Identifier: NCT03548402
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Heather McClary, Southern Methodist University

Tracking Information
First Submitted Date  ICMJE May 10, 2013
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date May 1, 2020
Actual Study Start Date  ICMJE March 19, 2012
Actual Primary Completion Date March 19, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2020)
Urges to Self-Injure [ Time Frame: During treatment (weeks 1-10) and 2 month follow-up ]
Whether there is a decrease in the participants self-reported urge to self-injure as measured by the Alexian Brothers Urge to Self-Injure Scale (ABUSI). Responses are on a 7-point scale with a maximum total score of 30 and higher scores reflecting more intense urges to self-injure.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
Urges to Self-Injure [ Time Frame: During treatment (weeks 1-10) and 2 month follow-up ]
Whether there is a decrease in the participants self-reported urge to self-injure as measured by the Alexian Brothers Urge to Self-Injure Scale (ABUSI)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
Experiential Avoidance [ Time Frame: During treatment (weeks 1-10) and at 2 month follow-up ]
Whether there are reductions in the participants self-reported experiential avoidance measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 24, 2018)
Anxiety [ Time Frame: During treatment (weeks 1-10) and at 2 month follow-up ]
Whether there are changes in the participants self-reported anxiety symptoms measured by the Anxiety Sensitivity Index (ASI)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Acceptance and Commitment Therapy for Nonsuicidal Self-injury
Official Title  ICMJE Acceptance and Commitment Therapy for Nonsuicidal Self-injury
Brief Summary

The goal of this study is to evaluate the effectiveness of Acceptance and Commitment Therapy (ACT) for individuals who engage in nonsuicidal self-injury(NSSI) and have comorbid anxiety.

With the data collected from the study, the investigators will test the following hypotheses:

Acceptance and commitment therapy will lead to reductions in anxiety and self-harm behaviors in non-suicidal self-injury individuals.

Detailed Description

Non-suicidal self-injury is the direct and purposeful harming of one's bodily tissue outside of social and religious norms and lacking suicidal intent. The most common NSSI behaviors include cutting (70-90%), banging or hitting (21-44%), and burning (15-35%) (Rodham & Hawton, 2009); but many report utilizing multiple methods (50-70%; Klonsky, 2011; Whitlock, Eckenrode, & Silverman, 2006). NSSI has an alarming prevalence among college students, with rates ranging from 17-38% (Whitlock et al., 2006; Gratz, Conrad, & Roemer, 2002). NSSI occurs in the context of many psychological disorders (Nock, 2010), and is associated with anxiety and mood disturbances (Andover et al., 2005). This is a prevalent problem and lacks an efficacious treatment. As a result, this study can shed insight into possible treatments.

The experiential avoidance model of deliberate self-harm posits that a function of self-injury is maintained through negative reinforcement by reducing unpleasant emotional arousal (Chapman et al. 2006). Therefore a treatment that directly targets reducing experiential avoidance is likely to be effective.

ACT is based on the theory that rigid attempts to control internal states, thoughts and feelings, and other forms of experiential avoidance contribute to symptom development and maintenance of anxiety and self-injury. The training includes three components: (a) educating Ps about the exacerbation of anxiety symptoms and problem behaviors through rigid attempts at experiential avoidance, (b) introducing acceptance and the willingness to experience anxiety-related sensations and cognitions as an alternative to experiential control, through the practice of intentional and non-judgmental paying attention to one's thoughts, feelings, images and bodily sensations (including aversive symptoms of anxiety) and learning to see thoughts as an ongoing process distinct from self rather than merely an event with literal meaning (cognitive defusing), and (c) instructing Ps in between-session exercises incorporating awareness of present, internal experiences and cognitive defusion exercises while engaging in exercises that give rise to them.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nonsuicidal Self-Injury
  • Anxiety
Intervention  ICMJE Behavioral: Acceptance and Commitment Therapy (ACT)
ACT is based on the theory that rigid attempts to control internal states, thoughts and feelings, and other forms of experiential avoidance contribute to symptom development and maintenance of anxiety and self-injury.
Study Arms  ICMJE Not Provided
Publications * Washburn JJ, Juzwin KR, Styer DM, Aldridge D. Measuring the urge to self-injure: preliminary data from a clinical sample. Psychiatry Res. 2010 Aug 15;178(3):540-4. doi: 10.1016/j.psychres.2010.05.018. Epub 2010 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2018)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date March 19, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. If applicable, be stabilized on their current medications for at least two months.
  2. Must report at least one incidence of self-injuring during the past six months.

Exclusion Criteria:

  • Active psychosis, schizophrenia and schizoaffective disorder Current active suicidal ideation Individuals with a history of seizure disorders, angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, transient ischemic attacks, cerebrovascular accidents, diabetes mellitus, significant asthma, emphysema, chronic obstructive pulmonary disease or a family history of heart disease before age 55 are also excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548402
Other Study ID Numbers  ICMJE 2012-029-MEUA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Heather McClary, Southern Methodist University
Original Responsible Party Alicia Meuret, Southern Methodist University, Associate Professor of Psychology
Current Study Sponsor  ICMJE Southern Methodist University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alicia Meuret, PhD Southern Methodist University
PRS Account Southern Methodist University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP