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The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury (SCORE)

perjantai 6. helmikuuta 2015 päivittänyt: Amy Bowles, M.D., Brooke Army Medical Center

Phase IV Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury

The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24 months post injury) cognitive complaints. This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study. Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks following the initiation of the study. The total number of patients to be studied is 160 (maximum), which is approximately 20 patients per month.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study: 1. Psychoeducational control group; 2. Non-therapist directed, computerized cognitive rehabilitation; 3. Therapist-directed individualized cognitive rehabilitation; and 4. Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. (Components of the treatment arms are described in detail in section 4.6; Research Design and Methods.) All subjects enrolled in the study will receive the standard of care in management of chronic post-concussive symptoms, consistent with the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009), regardless of treatment assignment. The standard of care includes provision of patient education materials (adapted from existing studies to address more persistent rather than acute symptom management), regular scheduled follow-up with a medical provider every three weeks, and symptom-based treatment of post-concussive complaints (e.g., medication trials for headache and co-occurring psychiatric disorders, physical therapy for vestibular complaints, case management, and supportive counseling with social work for soldiers assigned to the Warriors-in-Transition Battalion). Study participants who are assigned to treatment arms 2, 3, or 4 will additionally receive manualized cognitive rehabilitation therapies during the 6-week treatment phase of the study. Cognitive rehabilitation treatment intensity (i.e., number of hours of treatment per week) will be matched for individuals assigned to treatment arms 2, 3, or 4. Participants assigned to the control treatment group (treatment arm 1) will be offered individualized cognitive rehabilitation therapy if their cognitive complaints do not abate following the completion of the six-week treatment trial.

Study participants will be evaluated prior to the initiation of treatment, as well as at 3-weeks, 6-weeks, 12-weeks, and 18-weeks following the start of treatment. Study evaluators will be blind to treatment assignment. Pre-treatment baseline assessments and peri-/post-treatment outcome assessments will include demographic information, injury-related variables, self-report inventories, performance on neuropsychological testing, and functional status (e.g., work status; healthcare utilization). Detailed descriptions of the data to be collected including primary and secondary outcome measures, as well as co-variate measures can be found in section 4.8: Instrumentation.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

143

Vaihe

  • Vaihe 4

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • Texas
      • San Antonio, Texas, Yhdysvallat, 78234
        • Brooke Army Medical Center

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Diagnosis of mTBI as defined in the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009) which occurred during deployment in support of OEF/OIF within 3-24 months of study enrollment;
  • Presence of cognitive complaints (NSI score of 3 or higher on any of the four cognitive symptoms)
  • Ability to understand and communicate in English.

Exclusion Criteria:

  • Medical/psychiatric/neurologic co-morbidities of: blindness/low vision; uncontrolled seizure disorder; psychosis; history of moderate, severe TBI or penetrating BI; or Spinal Cord Injury with no use of upper extremities;
  • Active participation in intensive (> 5 appointments per week) treatment for amputation, orthopedic trauma, burns, substance abuse, or post-traumatic stress disorder which would preclude full participation in an intensive cognitive rehabilitation program; or
  • Daily use of narcotic pain medication(s).

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Tehtävätehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Muut: Standard of Care for mTBI Provider Arm
Arm 1: Psychoeducational Control Group. Individuals assigned to arm 1 will receive psychoeducational materials specifically adapted for persistent management of symptoms and routine follow-up with medical providers (every three weeks). Additionally, subjects assigned to this group will receive medical care (e.g., psychopharmacological management of depression) and/or referral for symptom management (e.g., vestibular rehabilitation) of non-cognitive complaints, consistent with the current standard of care treatment model for managing post-concussive symptoms (see Figure below adapted with permission from authors; Brenner et al., 2009).
Käyttäytyminen: Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
Kokeellinen: Computer Based Therapy Group
Arm 2: Non-therapist directed computerized cognitive rehabilitation. Individuals assigned to treatment arm 2 will receive ten hours of in-clinic, computerized treatment per week throughout the 6-week treatment trial. Participants will be scheduled for 2 hours per day, proctored by clinic staff (certified recreation therapist or neuropsychology technician) who will be responsible for recording daily performance, providing positive reinforcement of participation, and effort. Computer programs selected for this treatment trial include both skill-specific training (e.g., attention processes) and general cognitive activation. These computer programs are commercially available and advertised as "brain fitness" or "brain training."
Käyttäytyminen: Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
Käyttäytyminen: Brainworks
POSIT
Muut nimet:
  • POSIT
Kokeellinen: Cognitive Rehab Group
Arm 3: Therapist-directed individualized cognitive rehabilitation. Individuals assigned to treatment arm 3 will receive 10 hours of individual and group cognitive rehabilitation treatment (including homework assignments) per week conducted by credentialed speech therapists and occupational therapists. The treatment components will include five hours of weekly individual therapy (one-hour sessions; two hours focused on compensatory strategies and three hours focused on restorative strategies), two hours of weekly group therapy (one hour sessions focused on compensatory strategies), and three hours of weekly computer-based "homework" proctored by clinic staff who will be responsible for recording performance, and providing positive reinforcement of participation and effort.
Käyttäytyminen: Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
Käyttäytyminen: Cognitive Rehab
APT-III, Other standard individual and group interventions.
Muut nimet:
  • APT-III
Kokeellinen: Cognitive and Psychological Based Rehab
Arm 4: Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. Individuals assigned to treatment arm 4 will receive 10 hours of individual and group treatment per week conducted by credentialed therapists and doctoral-level psychologists. The treatment components will include four hours of weekly 1 hr individual therapy sessions; 2 hrs of cognitive rehabilitation, 1 hr of cognitive rehab & 1 hr of individual psychotherapy targeting anxiety/combat stress symptoms including relaxation training & exposure therapy and cognitive-behavioral principles, 3 hrs of weekly group therapy & three hours of weekly "homework" including 30-mins relaxation training, 30-mins cognitive-behavioral psychotherapy homework, and 2 hrs of computerized cognitive rehabilitation exercises proctored by clinic staff.
Käyttäytyminen: Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
Käyttäytyminen: Cognitive Rehab
APT-III, Other standard individual and group interventions.
Muut nimet:
  • APT-III

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Emotional Functioning
Aikaikkuna: Baseline

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
Baseline
Cognitive Efficiency
Aikaikkuna: Baseline

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
Baseline
Functional Behaviors
Aikaikkuna: Baseline
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
Baseline
Emotional Functioning
Aikaikkuna: 3 Weeks

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
3 Weeks
Emotional Functioning
Aikaikkuna: 6 Weeks

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
6 Weeks
Emotional Functioning
Aikaikkuna: 12 Weeks

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
12 Weeks
Emotional Functioning
Aikaikkuna: 18 Weeks

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
18 Weeks
Cognitive Efficiency
Aikaikkuna: 3 Weeks

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
3 Weeks
Cognitive Efficiency
Aikaikkuna: 6 Weeks

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
6 Weeks
Cognitive Efficiency
Aikaikkuna: 12 Weeks

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
12 Weeks
Cognitive Efficiency
Aikaikkuna: 18 Weeks

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
18 Weeks
Functional Behaviors
Aikaikkuna: 3 Weeks
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
3 Weeks
Functional Behaviors
Aikaikkuna: 6 Weeks
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
6 Weeks
Functional Behaviors
Aikaikkuna: 12 Weeks
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
12 Weeks
Functional Behaviors
Aikaikkuna: 18 Weeks
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
18 Weeks

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Fatigue
Aikaikkuna: Baseline
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Baseline
Post-Concussive Symptoms
Aikaikkuna: Baseline
Neurobehavioral Symptom Inventory Total Raw scale 22 individual items
Baseline
Self Reported Quality of Life
Aikaikkuna: Baseline

World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

Total score for each of the 5 subscale domains:

Overall Functioning Physical Capacity Psychological Social Relationships Environment
Baseline
Neuropsychological Status
Aikaikkuna: Baseline
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
Baseline
Self Reported Alcohol Use Behaviors
Aikaikkuna: Baseline
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Baseline
Post-Traumatic Stress Symptomatology
Aikaikkuna: 18 Weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
18 Weeks
Self Reported Headache Disability
Aikaikkuna: Baseline
Headache Impact Test-6 (HIT-6) Total Weighted Score
Baseline
Health Related (Cognition) Locus of Control
Aikaikkuna: Baseline
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
Baseline
Perceived Self-Efficacy (Cognition)
Aikaikkuna: Baseline
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Baseline
Attribution of Cognitive Symptoms
Aikaikkuna: Baseline
Cognitive Symptom Attribution Scale 7 individual items
Baseline
Therapist-Rated Patient Engagement in Treatment
Aikaikkuna: Week 6 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 6 of treatment
Post-Concussive Symptoms
Aikaikkuna: 6 Weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
6 Weeks
Post-Concussive Symptoms
Aikaikkuna: 12 weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
12 weeks
Post-Concussive Symptoms
Aikaikkuna: 18 weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
18 weeks
Fatigue
Aikaikkuna: 6 weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
6 weeks
Fatigue
Aikaikkuna: 12 Weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
12 Weeks
Fatigue
Aikaikkuna: 18 Weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
18 Weeks
Change in Healthcare Utilization
Aikaikkuna: 30 days prior to Baseline and 6 months post Baseline
Summed total number of appointments 30 days prior to study enrollment and summed total number of appointments for 30 days between 5 and 6 months post-treatment.
30 days prior to Baseline and 6 months post Baseline
Self Reported Quality of Life
Aikaikkuna: 6 weeks

World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

Total score for each of the 5 subscale domains:

Overall Functioning Physical Capacity Psychological Social Relationships Environment
6 weeks
Self Reported Quality of Life
Aikaikkuna: 12 weeks

World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

Total score for each of the 5 subscale domains:

Overall Functioning Physical Capacity Psychological Social Relationships Environment
12 weeks
Self Reported Quality of Life
Aikaikkuna: 18 weeks

World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

Total score for each of the 5 subscale domains:

Overall Functioning Physical Capacity Psychological Social Relationships Environment
18 weeks
Neuropsychological Status
Aikaikkuna: 6 Weeks
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
6 Weeks
Neuropsychological Status
Aikaikkuna: 12 Weeks
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
12 Weeks
Neuropsychological Status
Aikaikkuna: 18 Weeks
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
18 Weeks
Self Reported Alcohol Use Behaviors
Aikaikkuna: 6 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
6 weeks
Self Reported Alcohol Use Behaviors
Aikaikkuna: 12 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
12 weeks
Self Reported Alcohol Use Behaviors
Aikaikkuna: 18 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
18 weeks
Post-Traumatic Stress Symptomatology
Aikaikkuna: 6 weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
6 weeks
Post-Traumatic Stress Symptomatology
Aikaikkuna: Baseline
Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
Baseline
Post-Traumatic Stress Symptomatology
Aikaikkuna: 12 Weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
12 Weeks
Self Reported Headache Disability
Aikaikkuna: 6 weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
6 weeks
Self Reported Headache Disability
Aikaikkuna: 12 weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
12 weeks
Self Reported Headache Disability
Aikaikkuna: 18 Weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
18 Weeks
Health Related (Cognition) Locus of Control
Aikaikkuna: 6 weeks
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
6 weeks
Health Related (Cognition) Locus of Control
Aikaikkuna: 12 weeks
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
12 weeks
Health Related (Cognition) Locus of Control
Aikaikkuna: 18 weeks
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
18 weeks
Perceived Self-Efficacy (Cognition)
Aikaikkuna: 6 weeks
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
6 weeks
Perceived Self-Efficacy (Cognition)
Aikaikkuna: 12 weeks
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
12 weeks
Perceived Self-Efficacy (Cognition)
Aikaikkuna: 18 weeks
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
18 weeks
Attribution of Cognitive Symptoms
Aikaikkuna: 6 weeks
Cognitive Symptom Attribution Scale 7 individual items
6 weeks
Attribution of Cognitive Symptoms
Aikaikkuna: 12 weeks
Cognitive Symptom Attribution Scale 7 individual items
12 weeks
Attribution of Cognitive Symptoms
Aikaikkuna: 18 weeks
Cognitive Symptom Attribution Scale 7 individual items
18 weeks
Therapist-Rated Patient Engagement in Treatment
Aikaikkuna: Week 1 of Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 1 of Treatment
Therapist-Rated Patient Engagement in Treatment
Aikaikkuna: Week 2 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 2 of treatment
Therapist-Rated Patient Engagement in Treatment
Aikaikkuna: Week 3 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 3 of treatment
Therapist-Rated Patient Engagement in Treatment
Aikaikkuna: Week 4 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 4 of treatment
Therapist-Rated Patient Engagement in Treatment
Aikaikkuna: Week 5 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 5 of treatment

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Brooke Army Medical Center

Yhteistyökumppanit

Henry M. Jackson Foundation for the Advancement of Military Medicine
The Defense and Veterans Brain Injury Center

Tutkijat

  • Päätutkija: Amy O Bowles, MD, BAMC

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Keskiviikko 1. kesäkuuta 2011

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 1. kesäkuuta 2014

Opintojen valmistuminen (Todellinen)

Perjantai 1. elokuuta 2014

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 15. huhtikuuta 2011

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 20. huhtikuuta 2011

Ensimmäinen Lähetetty (Arvio)

Torstai 21. huhtikuuta 2011

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Maanantai 9. helmikuuta 2015

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 6. helmikuuta 2015

Viimeksi vahvistettu

Sunnuntai 1. helmikuuta 2015

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • C.2010.199

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