- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03548402
Acceptance and Commitment Therapy for Nonsuicidal Self-injury
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75206
- Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During treatment (weeks 1-10) and 2 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
During treatment (weeks 1-10) and at 2 month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
During treatment (weeks 1-10) and at 2 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alicia Meuret, PhD, Southern Methodist University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-029-MEUA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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