Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

Traumatic Brain Injury Clinical Trial

— CABA  

Official title:

Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02391402
• Other study ID #: D1189-I
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 4, 2015
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of Cognitively Augmented Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health Administration (VHA) treatment settings.

Description:

Veterans historically exhibit high rates of comorbid mTBI/PTSD. Given the comorbidity and neuropsychiatric symptom overlap of these disorders, it can be difficult to determine whether problems and disruptions in functioning are due to mTBI, PTSD, or both. Hence, it is challenging for providers to know how to prioritize these patients' clinical issues and how to effectively treat them. Currently, there are no evidence-based treatments for comorbid mTBI/PTSD. Further, it is unclear to what extent existing treatments for each disorder can be adherently and effectively implemented for the other. As such, most current treatment recommendations suggest a holistic or integrated approach to treatment for comorbid mTBI/PTSD targeting symptoms and functionality rather than underlying etiology. Investigators are proposing a treatment for comorbid mTBI and PTSD that directly targets daily functioning and quality of life.

The study design makes use of the convergent availability of resources at the two participating Veterans Administration Health Care Systems in Portland, Oregon, and Seattle, Washington to conduct a Randomized Controlled Trial (RCT) of CABA. The study will recruit a total of 192 Veterans less than or equal to 55 years of age, 96 participants at each site, enrolled at participating VA Medical Centers (VAMCs) who are diagnosed with both mTBI and PTSD. Eligible participants will be randomly assigned to either the CABA or Treatment as Usual (TAU) group. Participants in the CABA group will receive the CABA intervention during the first 14 weeks of their participation in the study, whereas TAU participants will continue to receive TAU (usual care in a PTSD specialty treatment clinic, but no CABA) during their participation in the study. Both groups will undergo evaluations at baseline, 7 weeks (mid-treatment), 14 weeks (post-treatment), and 39 weeks (6 month follow-up). During their study participation, all participants will continue to receive their usual medical care.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Veterans 55 years of age enrolled at participating VA sites able to provide informed consent.

• Diagnosis of PTSD based on the Clinician Administered PTSD Scale.

• Positive screen on the Structured Interview for Collecting Head Trauma Event Characteristics as per the VA/Department of Defense (DoD) Clinical Practice Guideline for Management of Concussion/mTBI; AND endorsed any of the Neurobehavioral Symptom Inventory (NSI) cognitive symptoms items (items 13-17).

• English speaking, able to travel to the primary care clinics weekly for 10 sessions and for the follow-up assessments, and willing to refrain from the initiation of additional mental health treatment during the first 3 1/2 months of the active phase of treatment if they are assigned to the CABA condition.

• Willingness to participate in audio-recorded sessions. (for treatment adherence)

Exclusion Criteria:

• Current diagnosis of moderate or severe substance (alcohol) use disorder using DSM-5 criteria within the past 30 days.

• Individuals with other psychiatric diagnoses will not be excluded except for bipolar disorder and psychotic disorders (requirement to refrain from additional treatments might be harmful).

• Veterans with a history indicated by medical record review of a diagnosis of moderate, severe, or penetrating TBI, or self-reported history on the Structured Interview for Collecting Head Trauma Event Characteristics of TBI with Post-Traumatic Amnesia (PTA) greater than 24 hours or loss of consciousness (LOC) greater than 30 minutes.

• Active suicidal intent indicating significant clinical risk, which would suggest that a treatment specifically targeting this intent was indicated. Clients who report suicidal ideation without imminent risk will be admitted into the study.

• Initiated psychotropic medication, including Prazosin, within 4 weeks or changed dosage within 2 weeks prior to the first assessment, as this would make it difficult to determine which treatment contributed to change in the CABA condition; additionally, started or changed dosage of sleep medication or low dosages of tricyclic antidepressant or trazodone for pain or sleep within 1 week prior to the first assessment. Participants could be reconsidered for eligibility after stability on medication was achieved. Enrollees will be asked to hold the doses of the current medications stable over the course of enrollment (though changes in medications after enrollment will not exclude them from on-going participation).

• Auditory or visual impairments that would compromise ability to participate or benefit.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• Cognitively Augmented Behavioral Activation
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
• Treatment as Usual
TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale - 5	PTSD diagnosis.	14 weeks
Primary	Change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale - 5	PTSD diagnosis.	39 weeks
Primary	Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5	PTSD symptom severity.	7 weeks
Primary	Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5	PTSD symptom severity.	14 weeks
Primary	Change in PTSD symptoms from baseline as measured by the PTSD Checklist-5	PTSD symptom severity.	39 weeks
Primary	Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory	Postconcussion symptom severity.	7 weeks
Primary	Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory	Postconcussion symptom severity.	14 weeks
Primary	Change in postconcussion symptoms from baseline as measured by the Neurobehavioral Symptom Inventory	Postconcussion symptom severity.	39 weeks
Primary	Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II	Measures symptoms of depression and severity.	7 weeks
Primary	Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II	Measures symptoms of depression and severity.	14 weeks
Primary	Change in symptoms of depression from baseline as measured by the Beck Depression Inventory -II	Measures symptoms of depression and severity.	39 weeks
Primary	Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation	Measures suicidal ideation.	7 weeks
Primary	Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation	Measures suicidal ideation.	14 weeks
Primary	Change in risk of suicidal ideation from baseline as measured by the Scale for Suicide Ideation	Measures suicidal ideation.	39 weeks
Primary	Change in memory from baseline as measured by the Hopkins Verbal Memory Test - Revised	Measures learning and memory function.	14 weeks
Primary	Change in memory from baseline as measured by the Hopkins Verbal Memory Test - Revised	Measures learning and memory function.	39 weeks
Primary	Change in attention and working memory from baseline as measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest	Measures attention and working memory function.	14 weeks
Primary	Change in attention and working memory from baseline as measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest	Measures attention and working memory function.	39 weeks
Primary	Change in processing speed from baseline as measured by the Wechsler Adult Intelligence Scale-3rd Edition, Symbol Search Subtest	Measures processing speed.	14 weeks
Primary	Change in processing speed from baseline as measured by the Wechsler Adult Intelligence Scale-3rd Edition, Symbol Search Subtest	Measures processing speed.	39 weeks
Primary	Change in verbal fluency from baseline as measured by the Controlled Oral Word Association Test	Measures fluency.	14 weeks
Primary	Change in verbal fluency from baseline as measured by the Controlled Oral Word Association Test	Measures fluency.	39 weeks
Secondary	Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire	Measures postconcussion symptom severity.	7 weeks
Secondary	Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire	Measures postconcussion symptom severity.	14 weeks
Secondary	Change in postconcussion symptoms from baseline as measured by the Rivermead Postconcussive Questionnaire	Measures postconcussion symptom severity.	39 weeks
Secondary	Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire	Measures use of memory strategies in daily living.	7 weeks
Secondary	Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire	Measures use of memory strategies in daily living.	14 weeks
Secondary	Change in the use of cognitive strategies from baseline as measured by the Memory Compensation Questionnaire	Measures use of memory strategies in daily living.	39 weeks
Secondary	Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory	Measures symptoms of anxiety.	7 weeks
Secondary	Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory	Measures symptoms of anxiety.	14 weeks
Secondary	Change in symptoms of anxiety from baseline as measured by the Brief Symptom Inventory	Measures symptoms of anxiety.	39 weeks
Secondary	Change in health related quality of life from baseline as measured by the Neuro-QOL	Measures quality of life.	7 weeks
Secondary	Change in health related quality of life from baseline as measured by the Neuro-QOL	Measures quality of life.	14 weeks
Secondary	Change in health related quality of life from baseline as measured by the Neuro-QOL	Measures quality of life.	39 weeks
Secondary	Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale	Measures quality of life.	7 weeks
Secondary	Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale	Measures quality of life.	14 weeks
Secondary	Change in global life satisfaction from baseline as measured by the Satisfaction with Life Scale	Measures quality of life.	39 weeks
Secondary	Change in functional impairment from baseline as measured by the Sheehan Disability Scale	Measures impact of functional impairment on activities.	7 weeks
Secondary	Change in functional impairment from baseline as measured by the Sheehan Disability Scale	Measures impact of functional impairment on activities.	14 weeks
Secondary	Change in functional impairment from baseline as measured by the Sheehan Disability Scale	Measures impact of functional impairment on activities.	39 weeks