Attention-Bias Modification Treatment for PTSD

Research Foundation for Mental Hygiene (RFMH)

Status: Completed

Conditions: Posttraumatic Stress Disorder (PTSD)

Treatments: Behavioral: Attention control training (ACT); Behavioral: Attention Bias Modification (ABM)

Study type: Interventional

Funder types: Other

Identifiers

NCT01888653

IRB# 6688

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Comparison-Training-Program

Placebo Comparator group

Description:

Placebo-training program: attention control training (ACT), is identical to the ABM protocol except that during the presentation of the trials where a threat word is presented, the probe will appear with equal frequency in the position of the threat and neutral word. Thus, neither threat nor neutral words provide information regarding the position of the target probe, and there is no contingency between the position of either threat or neutral words, and the position of the probes

Treatment:

Behavioral: Attention control training (ACT)

Attention Biased Modification

Active Comparator group

Description:

Attention-bias-modification treatment (ABM) is designed to implicitly modify patients' biased threat attendance via computerized training protocols. During each session, 240 trials (80 neutral-neutral pairs, 160 threat-neutral pairs) will be presented. On trials where participants see one neutral word and one threat word, the probe will always follow the neutral word location. Thus, although there is no specific instruction to direct attention away from threat words, on 66% of all trials (and 100% of the threat-neutral trials) the position of the neutral word will indicate the position of the target probe.

Treatment:

Behavioral: Attention Bias Modification (ABM)