Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Psychotherapie-Ambulanz Marburg e.V.
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00596765
First received: January 8, 2008
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Acquired brain injury can result in impaired everyday functioning as well as psychosocial problems, including depressive symptoms, irritability, or negative self-concept. The purpose of this study is to determine whether a combination of neuropsychological and cognitive behavioral therapy is effective in the treatment of these sequelae.


Condition Intervention Phase
Brain Injury
Behavioral: Neuropsychological Cognitive Behavioral Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Neuropsychological Therapy for Patients With Acquired Brain Injury Focusing on the Role of Psychosocial Adjustment Using a Cognitive Behavioral Approach

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Psychosocial Adjustment/ Everyday Functioning as a composite score of SCL-90-R and AFIB [ Time Frame: Pre-/ Post-Design, including 3 ponts of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life (Qolibri, Seiqol, SWLS) [ Time Frame: Pre-/ Post-Design, including 3 points of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later ] [ Designated as safety issue: No ]
  • Self-concept/ Life Goals (HISDS II; GOALS; RSES-REV; Self-complexity Measure; FSKN) [ Time Frame: Pre-/ Post-Design, including 3 points of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later ] [ Designated as safety issue: No ]
  • Psychopathology/ Affect (ADS; PANAS) [ Time Frame: Pre-/ Post-Design, including 3 points of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later ] [ Designated as safety issue: No ]
  • Community Integration (CIQ) [ Time Frame: Pre-/ Post-Design, including 3 points of measurement: at the beginning of therapy/ waiting period; immediately after completion of therapy/ waiting period; catamnestic measurement 6 months later ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2007
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Neuropsychological cognitive behavioral psychotherapy for patients with acquired brain injury consists of 25 weekly 1-hr sessions of individualized outpatient treatment. The therapeutical intervention is modularised, patients are assigned to specific interventional modules according to the results of cognitive testing and interviews. Modules concern on the one hand the treatment of deficits in attention, memory, and executive functions. On the other hand psychosocial adjustment to chronic illness is addressed through modules that concern the development of a positive self-concept, the adjustment of life-goals and coping with negative affect (e.g. depressive symptoms, irritability, guilt).
Behavioral: Neuropsychological Cognitive Behavioral Therapy
Neuropsychological Cognitive Behavioral Therapy encompasses 2 foci: First emphasis is on neuropsychological compensatory strategies for the treatment of deficits in attention, memory, and executive functions. Secondly, cognitive behavioral intervention techniques are employed to support the patient in the process of coping with chronic illness: i.e. improve regulation of negative affect, diversify the impaired self-concept after acquired brain injury, and adjust important life-goals to changed circumstances.
2

Waiting list: Patients are randomly assigned to one of two existing groups after completion of the first session of various neuropsychological tests and interviews.

Patients assigned to the experimental group receive therapy immediately after completing the first session of various neuropsychological tests and interviews. Patients randomized to the waiting list receive the treatment as specified above after waiting for 5 month.

Behavioral: Neuropsychological Cognitive Behavioral Therapy
Neuropsychological Cognitive Behavioral Therapy encompasses 2 foci: First emphasis is on neuropsychological compensatory strategies for the treatment of deficits in attention, memory, and executive functions. Secondly, cognitive behavioral intervention techniques are employed to support the patient in the process of coping with chronic illness: i.e. improve regulation of negative affect, diversify the impaired self-concept after acquired brain injury, and adjust important life-goals to changed circumstances.

Detailed Description:

Acquired brain injury (ABI) commonly results in persistent cognitive, emotional and motivational problems. About 50% of patients involved develop psychiatric illness, most likely in the first year following ABI, which is associated with reduced psychosocial functioning and less favorable rehabilitation outcome. Treatment of these complex conditions requires a combination of neuropsychological and psychotherapeutic intervention techniques.

This study aims at evaluating a combination of neuropsychological intervention methods, which include developing and using compensation strategies for cognitive impairments (attention, memory and executive functions), and psychotherapeutic intervention focusing on emotion regulation, developing positive self-concepts and adjustment of life-goals. These therapeutic interventions are modularized and patients are assigned to intervention modules according to results of objective neuropsychological testing and interviews.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having suffered an acquired brain injury after the age of 14, such as traumatic brain injury, neoplasm (after surgery), toxic brain damage, or brain damages through inflammatory diseases
  • Being at least 3 months post injury
  • Being German-speaking
  • Agreeing to participate, verified by completion of informed consent

Exclusion Criteria:

  • Suffering from recurrent, degenerative, or progressive neurological diseases (e.g. multiple sclerosis, dementia, Chorea Huntington)
  • Current or past psychosis or bipolar disorder
  • Current or past diagnosis of substance dependency
  • History of mental retardation
  • Currently in psychotherapy
  • Severe lateralized disorder (e.g. aphasia, neglect)
  • Lacking minimum basic skills for attending therapy (e.g. not orientated to person, place, time, and events; unable to sustain attention for an hour-long session; cannot state cognitive strengths and weaknesses; cannot state areas in everyday functioning that are impaired due to the acquired brain injury)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596765

Locations
Germany
Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy
Marburg, Germany, 35037
Psychotherapie-Ambulanz Marburg
Marburg, Germany
Sponsors and Collaborators
Philipps University Marburg Medical Center
Psychotherapie-Ambulanz Marburg e.V.
Investigators
Principal Investigator: Cornelia Exner, Dr. (PhD) Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Study Director: Winfried Rief, Prof. Dr. Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
  More Information

Additional Information:
No publications provided

Responsible Party: Winfried Rief, Prof. Dr. Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00596765     History of Changes
Other Study ID Numbers: NeuroPsy_Ex2007
Study First Received: January 8, 2008
Last Updated: April 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Philipps University Marburg Medical Center:
Brain Injury
Neuropsychology
Cognitive Behavioral Therapy
Neuropsychological Rehabilitation

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014