Acceptance and Commitment Therapy for Nonsuicidal Self-injury
Primary Purpose
Nonsuicidal Self-Injury, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT)
Sponsored by
About this trial
This is an interventional treatment trial for Nonsuicidal Self-Injury
Eligibility Criteria
Inclusion Criteria:
- If applicable, be stabilized on their current medications for at least two months.
- 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.
Sites / Locations
- Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University
Outcomes
Primary Outcome Measures
Urges to Self-Injure
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.
Secondary Outcome Measures
Experiential Avoidance
Whether there are reductions in the participants self-reported experiential avoidance measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Full Information
NCT ID
NCT03548402
First Posted
May 10, 2013
Last Updated
April 29, 2020
Sponsor
Southern Methodist University
1. Study Identification
Unique Protocol Identification Number
NCT03548402
Brief Title
Acceptance and Commitment Therapy for Nonsuicidal Self-injury
Official Title
Acceptance and Commitment Therapy for Nonsuicidal Self-injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 19, 2012 (Actual)
Primary Completion Date
March 19, 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Methodist University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsuicidal Self-Injury, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Urges to Self-Injure
Description
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.
Time Frame
During treatment (weeks 1-10) and 2 month follow-up
Secondary Outcome Measure Information:
Title
Experiential Avoidance
Description
Whether there are reductions in the participants self-reported experiential avoidance measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame
During treatment (weeks 1-10) and at 2 month follow-up
Other Pre-specified Outcome Measures:
Title
Anxiety
Description
Whether there are changes in the participants self-reported anxiety symptoms measured by the Anxiety Sensitivity Index (ASI)
Time Frame
During treatment (weeks 1-10) and at 2 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
If applicable, be stabilized on their current medications for at least two months.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Meuret, PhD
Organizational Affiliation
Southern Methodist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20580437
Citation
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.
Results Reference
background
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Acceptance and Commitment Therapy for Nonsuicidal Self-injury
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