What is the mechanism of action of this treatment?

Common treatments for PTSD, such as Goal Management Training plus Computerized Attention Training, focus on cognitive rehabilitation through structured goal-setting and computerized exercises. These methods aim to enhance attention and executive function, which are often compromised in PTSD patients. By improving these cognitive skills, patients can better manage their symptoms, leading to improved daily functioning and reduced distress. This approach is crucial for PTSD patients as it directly addresses the cognitive deficits that exacerbate their condition.

What side effects are associated with this type of intervention?

Common treatments for PTSD, such as cognitive rehabilitation and cognitive-behavioral therapy (CBT), generally have minimal physical side effects compared to pharmacological treatments. However, patients may experience emotional discomfort, increased anxiety, or distress during exposure exercises and therapy sessions as they confront traumatic memories. Additionally, some individuals may feel overwhelmed or fatigued due to the cognitive demands of structured goal-setting and computerized exercises. It is important for patients to work closely with their therapists to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PTSD, primarily focusing on pharmacological interventions such as selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine. However, cognitive rehabilitation approaches like Goal Management Training plus Computerized Attention Training, which involve structured goal-setting and computerized exercises to enhance attention and executive function, are not typically covered under FDA drug approvals. These methods are more aligned with psychotherapeutic and cognitive training interventions rather than pharmacological treatments.

What other types of research exist?

Promising novel alternatives for PTSD treatment in 2024 include: 1) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in sleep-related quality of life and psychological well-being, potentially benefiting PTSD patients with comorbid insomnia. 2) Telehealth-delivered Cognitive Processing Therapy (CPT) combined with Cognitive Symptom Management and Rehabilitation Therapy (SMART-CPT), which addresses both PTSD symptoms and cognitive impairments. 3) Schema-focused Cognitive Therapy, which targets maladaptive thinking patterns and has potential benefits for PTSD patients. These alternatives offer innovative approaches to enhance cognitive and emotional functioning in PTSD patients.

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Behavioural Intervention

Combined Metacognitive Training for mTBI/PTSD

N/A

Recruiting

Led By Julia K. Waid-Ebbs, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Veterans who have served in OIF-OEF-OND and have been diagnosed with both a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) based on the joint criteria of the Veterans' Affairs and Department of Defense (VA & DoD).

Be between 18 and 65 years old

Must not have

Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).

History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention, post, 6-month and 1-year follow-up

Summary

This trial will test a new treatment combining goal management and computer-based attention training for Veterans with mild brain injuries and PTSD. The goal is to improve their focus, problem-solving skills, and daily functioning. The study will compare in-person and telehealth delivery methods. Goal Management Training (GMT) has been previously tested for improving cognitive functioning in individuals with PTSD.

Who is the study for?

This trial is for Veterans who served in OIF-OEF-OND, diagnosed with mild traumatic brain injury (mTBI) and PTSD at least 6 months ago. They must have attention deficits, access to a computer or smartphone with internet, and a friend or family member willing to fill out a questionnaire. Excluded are those with learning disabilities, ongoing litigation related to their injury, recent medication changes for seizures/depression/memory, other cognitive therapy participation, non-fluent English speakers, severe psychiatric history leading to hospitalization.

What is being tested?

The study tests Goal Management Training combined with Attention Training against Brain Health Workshops and National Geographic Movies in improving cognition for Veterans with mTBI/PTSD. It will compare the effectiveness of these treatments delivered both in-person and via telehealth on executive function and real-life tasks.

What are the potential side effects?

Since this trial involves cognitive training programs rather than medications or invasive procedures, traditional side effects are not expected. However, participants may experience fatigue or frustration during the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a veteran of OIF-OEF-OND with diagnosed mTBI and PTSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I understand the study's expectations and risks and can consent.

Select...

I have been hospitalized for a psychiatric condition.

Select...

I have a neurological condition not caused by brain injury.

Select...

I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention, post, 6-month and 1-year follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention, post, 6-month and 1-year follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention, post, 6-month and 1-year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Composite Executive score of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research

Secondary study objectives

Change in Attention Network Task

Traumatic Brain Injury

Change in the Test of Grocery Shopping Skills

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Telehealth GMT plus Attention TrainingExperimental Treatment1 Intervention

Goal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted over the VA VideoConnect weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist via VA VideoConnect. Participant completed 5-6 hours of homework between sessions

Group II: Inpatient GMT plus Attention TrainingExperimental Treatment1 Intervention

Goal Management Training is a group metacognitive intervention to improve ability to complete complex task more effectively. 2-hour session are conducted in-person weekly over 10-weeks. A second weekly session includes Attention training which is conducted one-on-one with the therapist in the clinic. Participant completed 5-6 hours of homework between sessions.

Group III: Brain Health WorkshopPlacebo Group1 Intervention

Brain Health Workshop includes educational information about the brain to control for GMT and National Geographic Movies is used as a control to equate time with therapist in Attention Training. Each session occurs weekly for 2-hours over 10-weeks.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for PTSD, such as Goal Management Training plus Computerized Attention Training, focus on cognitive rehabilitation through structured goal-setting and computerized exercises. These methods aim to enhance attention and executive function, which are often compromised in PTSD patients. By improving these cognitive skills, patients can better manage their symptoms, leading to improved daily functioning and reduced distress. This approach is crucial for PTSD patients as it directly addresses the cognitive deficits that exacerbate their condition.

Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury.Improvement in executive functioning after Goal-Oriented Attentional Self-Regulation training is associated with reduction in PTSD hyperarousal symptoms among veterans with comorbid PTSD and mild TBI.