Repeated Imaginal Exposure for PTSD

Overseen By Carla Kmett Danielson, Ph.D.

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Medical University of South Carolina

Must not be taking: Psychotropic medications

Disqualifiers: Intellectual disability, Psychosis, Bipolar, Anorexia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This study examines how adolescents with trauma-related symptoms respond to stress and strong emotions. The study assesses brain activity, physiological responses, and behavior during experimental tasks that involve responding to potential threats, regulating emotions, and repeatedly imagining details of a personally experienced stressful or traumatic event using a script-driven imagery task.

The study evaluates whether repeated imaginal exposure is associated with changes in anxiety and physiological responses across sessions, and whether baseline patterns of threat reactivity and emotion regulation are associated with individual differences in response to the exposure task. Outcomes include self-reported anxiety, subjective distress ratings, and psychophysiological indices such as heart rate, skin conductance, and electromyographic activity.

The goal of this research is to improve understanding of biobehavioral processes related to trauma exposure in adolescents and to identify potential predictors of response to exposure-based intervention components relevant to posttraumatic stress disorder (PTSD).

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to comprehend English

Endorsement of exposure to one or more potentially traumatic event(s), as defined by DSM-5 Criterion A event, that the adolescent remembers and is able to verbalize

A total score ≥15 on the Child and Adolescent Trauma Screen (CATS) or report at least one clinically significant symptom on Intrusion/Re-experiencing, Avoidance, and Hyperarousal symptom domains, as defined by DSM-5 PTSD criteria, and one area of impairment

Exclusion Criteria

I do not have an intellectual or developmental disability that prevents me from understanding the study.

I do not have active psychosis, bipolar disorder, or severe conditions needing urgent care.

Active suicide risk with ideation, plan and intent and/or recent (past 6 months) hospitalization for suicidality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo repeated imaginal exposure tasks to assess changes in anxiety and physiological responses

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Repeated imaginal exposure: Script Driven Imagery (SDI) task

How Is the Trial Designed?

Group I: Exposure Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+