Recruiting

Telehealth Therapy

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07196332

Conditions

Post-traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Brief Behavioral Treatment for Insomnia (BBTI)

Progressive Muscle Relaxation Training (PMRT)

Study Details

Brief summary:

The main objective of this pilot trial is to assess the feasibility and preliminary efficacy of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk. This pilot trial will provide the data necessary to design and support a large-scale trial.

Conditions

Post-traumatic Stress Disorder

Study ID

NCT07196332

Start date

Apr 30, 2026

Status verified date

Feb, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Alert and oriented at time of screening
2. Written and spoken English
3. Age 18-65
4. Presents to the ED within 72 hours of MVC
5. Discharged home after ED evaluation
6. Has an email and mailing address
7. Owns a smartphone compatible with iOS or Android, has not experienced service interruption due to non-payment in the past year, and has maintained the same phone number for at least one year
8. Meets PTSD risk score criteria (score of ≥ 16 on the PTSD risk stratification tool)
9. Willing to participate in four remote therapy sessions

Exclusion Criteria:

1. Age <18 or >65
2. Pregnant
3. Prisoner or in police custody
4. Present to ED >72 hours after trauma
5. Admitted to the hospital after ED evaluation
6. Severely injured (e.g., severely broken bones) as a result of the MVC that, in the opinion of the investigator, may impact PTSD trajectories
7. Had a change in psychiatric medication or psychotherapy regimen within 1 month of enrollment
8. Currently receiving or planning to receive evidence-based treatments that directly target insomnia or PTSD (e.g., CBT-I, Cognitive Processing Therapy, or Prolonged Exposure Therapy)
9. MVC was self-inflicted or occupation-related
10. Report or indicate that they are experiencing ongoing domestic violence
11. Has conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features, manic or hypomanic episodes. We will not exclude individuals based on any other mental health condition, including depression

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Brief Behavioral Treatment for Insomnia (BBTI)

Four sessions of telehealth-delivered brief behavioral treatment for insomnia

active comparator: Progressive Muscle Relaxation Training (PMRT)

Four sessions of telehealth-delivered progressive muscle relaxation training

Interventions

Brief Behavioral Treatment for Insomnia (BBTI)

In the first week, treatment consists of a 60-minute video individual intervention session; in the second week, participants receive a 30-minute phone call; in the third week, treatment consists of a 45-minute video individual session; the final session consists of a 30-minute phone call. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of homeostatic and circadian mechanisms of human sleep regulation. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.

Progressive Muscle Relaxation Training (PMRT)

In the first week, treatment consists of a 60-minute video individual intervention session; in the second week, participants receive a 30-minute phone call; in the third week, treatment consists of a 45-minute video individual session; the final session consists of a 30-minute phone call. Treatment begins with learning how to alternately tense and relax 14 major muscle groups, and then to use progressively more efficient tensing-relaxing and passive relaxation exercises, with sessions used to teach techniques and problem-solve barriers to its daily use.

Primary outcome measure

  • Changes in PTSD Symptom Severity Over Time [ Time Frame: Baseline, Week 4, Week 8, Month 3 ]
  • Recruitment Rates [ Time Frame: Baseline ]
  • Retention Rates [ Time Frame: Month 3 ]
  • Treatment Completion Rates [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Andrea A Massa, PhD

(919) 966-1644REST@unc.edu

Romina Soudavari, MPH

(919) 966-1644REST@unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27516

Contacts

Andrea A Massa, PhD

919-966-1644REST@unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

May 4, 2026

Last verified

Feb, 2026

Keywords

  • Trauma and Stressor Related Disorders
  • Mental Disorders
  • Stress Disorders, Traumatic
  • Stress Disorders, Post-Traumatic
  • Motor Vehicle Collision

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-05-04.