NCT03548402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

May 10, 2013

Last Update Submit

April 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    During treatment (weeks 1-10) and 2 month follow-up

Secondary Outcomes (1)

  • Experiential Avoidance

    During treatment (weeks 1-10) and at 2 month follow-up

Other Outcomes (1)

  • Anxiety

    During treatment (weeks 1-10) and at 2 month follow-up

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stress, Anxiety, and Chronic Disease Research Program, Southern Methodist University

Dallas, Texas, 75206, United States

Location

Related Publications (1)

  • 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.

    PMID: 20580437BACKGROUND

MeSH Terms

Conditions

Self-Injurious BehaviorAnxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Alicia Meuret, PhD

    Southern Methodist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research Compliance

Study Record Dates

First Submitted

May 10, 2013

First Posted

June 7, 2018

Study Start

March 19, 2012

Primary Completion

March 19, 2015

Study Completion

May 1, 2015

Last Updated

May 1, 2020

Record last verified: 2020-04

Locations