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

6. Februar 2015 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

143

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Texas
      • San Antonio, Texas, Vereinigte Staaten, 78234
        • Brooke Army Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: 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).
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
Experimental: 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."
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
POSIT
Andere Namen:
  • POSIT
Experimental: 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.
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
APT-III, Other standard individual and group interventions.
Andere Namen:
  • APT-III
Experimental: 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.
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
APT-III, Other standard individual and group interventions.
Andere Namen:
  • APT-III

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Emotional Functioning
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fatigue
Zeitfenster: Baseline
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Baseline
Post-Concussive Symptoms
Zeitfenster: Baseline
Neurobehavioral Symptom Inventory Total Raw scale 22 individual items
Baseline
Self Reported Quality of Life
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Baseline
Post-Traumatic Stress Symptomatology
Zeitfenster: 18 Weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
18 Weeks
Self Reported Headache Disability
Zeitfenster: Baseline
Headache Impact Test-6 (HIT-6) Total Weighted Score
Baseline
Health Related (Cognition) Locus of Control
Zeitfenster: 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)
Zeitfenster: Baseline
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Baseline
Attribution of Cognitive Symptoms
Zeitfenster: Baseline
Cognitive Symptom Attribution Scale 7 individual items
Baseline
Therapist-Rated Patient Engagement in Treatment
Zeitfenster: Week 6 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 6 of treatment
Post-Concussive Symptoms
Zeitfenster: 6 Weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
6 Weeks
Post-Concussive Symptoms
Zeitfenster: 12 weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
12 weeks
Post-Concussive Symptoms
Zeitfenster: 18 weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
18 weeks
Fatigue
Zeitfenster: 6 weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
6 weeks
Fatigue
Zeitfenster: 12 Weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
12 Weeks
Fatigue
Zeitfenster: 18 Weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
18 Weeks
Change in Healthcare Utilization
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
6 weeks
Self Reported Alcohol Use Behaviors
Zeitfenster: 12 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
12 weeks
Self Reported Alcohol Use Behaviors
Zeitfenster: 18 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
18 weeks
Post-Traumatic Stress Symptomatology
Zeitfenster: 6 weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
6 weeks
Post-Traumatic Stress Symptomatology
Zeitfenster: Baseline
Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
Baseline
Post-Traumatic Stress Symptomatology
Zeitfenster: 12 Weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
12 Weeks
Self Reported Headache Disability
Zeitfenster: 6 weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
6 weeks
Self Reported Headache Disability
Zeitfenster: 12 weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
12 weeks
Self Reported Headache Disability
Zeitfenster: 18 Weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
18 Weeks
Health Related (Cognition) Locus of Control
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 6 weeks
Cognitive Symptom Attribution Scale 7 individual items
6 weeks
Attribution of Cognitive Symptoms
Zeitfenster: 12 weeks
Cognitive Symptom Attribution Scale 7 individual items
12 weeks
Attribution of Cognitive Symptoms
Zeitfenster: 18 weeks
Cognitive Symptom Attribution Scale 7 individual items
18 weeks
Therapist-Rated Patient Engagement in Treatment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 5 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 5 of treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2011

Primärer Abschluss (Tatsächlich)

1. Juni 2014

Studienabschluss (Tatsächlich)

1. August 2014

Studienanmeldedaten

Zuerst eingereicht

15. April 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. April 2011

Zuerst gepostet (Schätzen)

21. April 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

9. Februar 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Februar 2015

Zuletzt verifiziert

1. Februar 2015

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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