Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

NCT02391402 | Completed Results

• 1 other identifier: D1189-I
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Traumatic Brain Injury; Posttraumatic Stress Disorder

Keywords

Brain injury; TBI; PTSD; Polytrauma

Outcome Measures

Primary Outcomes (12)

• PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5

  The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, \& Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, \& Keane, 1999).

  0 weeks

• PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5

  The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, \& Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, \& Keane, 1999).

  14 weeks

• PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5

  The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, \& Forneris, 1996; Weathers, Litz, Herman, Huska, \& Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations.

  0 weeks

• PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5

  The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, \& Forneris, 1996; Weathers, Litz, Herman, Huska, \& Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations.

  14 weeks

• Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised

  The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance.

  0 weeks

• Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised

  The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance.

  14 weeks

• Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest

  The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance.

  0 weeks

• Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest

  The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance.

  14 weeks

• Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test

  The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum).

  0 weeks

• Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test

  The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum).

  14 weeks

• Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline

  The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, \& Kramer, 2001; Delis, Kramer, Kaplan, \& Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4.

  0 weeks

• Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest

  The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, \& Kramer, 2001; Delis, Kramer, Kaplan, \& Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4.

  14 weeks

Secondary Outcomes (7)

• Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II

  0 weeks

• Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II

  14 weeks

• Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale

  0 weeks

• Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale

  14 weeks

• Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory

  0 weeks

Other Outcomes (10)

• Use of Cognitive Strategies From Baseline as Measured by the Memory Compensation Questionnaire

  0 weeks

• Use of Cognitive Strategies at 14 Weeks as Measured by the Memory Compensation Questionnaire

  14 weeks

• Postconcussion Symptoms From Baseline as Measured by the Rivermead Postconcussive Questionnaire

  0 weeks

Study Arms (2)

CABA

EXPERIMENTAL

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.

Behavioral: Cognitively Augmented Behavioral Activation

TAU

PLACEBO COMPARATOR

Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. 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.

Behavioral: Treatment as Usual

Interventions

Cognitively Augmented Behavioral Activation BEHAVIORAL

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.

Also known as: CABA

CABA

Treatment as Usual BEHAVIORAL

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.

Also known as: TAU

TAU

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Brain Injuries; Multiple Trauma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

This study experienced significant recruitment delays and difficulties associated with delayed IRB approvals and COVID-era shutdowns. As a result, the sample size is smaller than expected.

Results Point of Contact

• Title: Megan Callahan
• Organization: Portland VA

megan.callahan@va.gov

503-220-8262

Study Officials

• Megan Callahan, PsyD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 18, 2015
• Study Start: May 4, 2015
• Primary Completion: March 31, 2021
• Study Completion: September 30, 2023
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)