N/A
N=50
Attention-Bias Modification Treatment for PTSD
Posttraumatic Stress Disorder (PTSD)
Bottom Line
View on ClinicalTrials.gov: NCT01888653 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Primary Outcome: Clinician Administered PTSD Scale (CAPS) — 26.44; 15.96 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Attention Bias Modification (ABM) (Behavioral); Attention control training (ACT) (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Research Foundation for Mental Hygiene, Inc.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome: Clinician Administered PTSD Scale (CAPS) |
26.44; 15.96 | — |
| SECONDARY Secondary Outcome: PTSD Check List-Civilian (PCL-C) |
20.22; 7.84 | — |
Summary
Emerging research implicates biased attention to threat in the pathophysiology of anxiety disorders. Recent findings demonstrate significant associations between attention bias and stress vulnerability. This work has motivated the development of a novel therapy, attention-bias-modification (ABM) treatment . ABM is designed to implicitly modify patients' biased threat attendance via computerized training protocols. Emerging evidence indicates that ABM is effective in modifying threat-related attention biases and in ameliorating anxiety symptoms. However, it is unclear whether ABM is efficacious for posttraumatic stress disorder (PTSD). The present pilot study is a double blind trial that seeks to examine feasibility, acceptability, safety, efficacy, and risk/benefit ratio of ABM in individuals with PTSD. In addition this pilot study seeks to identify specific genes associated with anxiety disorders and to examine whether these can predict the success of the ABM.
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 60;
- Current DSM-IV PTSD for the last 12 months or more;
- Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol;
- Attention bias toward or away from threat assessed by Dot-probe attention bias task
Exclusion Criteria
- Current DSM-IV Axis I disorder other than PTSD.
- Patients with comorbid (i.e., secondary diagnosis of) major depressive disorder (MDD) will be allowed for enrollment if their HAM-D score doesn't exceed 25;
- Prior or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, and schizoid personality disorders;
- Suicidal ideation or behavior that poses a significant danger to the subject. Unstable clinical condition such that participation in a controlled trial would pose a significant danger;
- Prior participation in attention bias modification treatment (ABMT);
- Current or past history of seizure disorder (except febrile seizure in childhood);
- Currently on psychotropic medication. (excluding the use of hypnotics);
- Currently participating in formal psychotherapy. This includes:
- psychodynamic,
- cognitive behavioral and interpersonal therapies
- Current unstable or untreated medical illness;
- Vision loss.
Data sourced from ClinicalTrials.gov (NCT01888653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.