Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury
This study is currently recruiting participants.
Verified October 2012 by Philipps University Marburg Medical Center
Sponsor:
Philipps University Marburg Medical Center
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: October 31, 2012
Last verified: October 2012
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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 2013 |
| Estimated Primary Completion Date: | November 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596765
Contacts
| Contact: Cornelia Exner, Dr. (PhD) | ++49-6421-2826738 | exnerc@staff.uni-marburg.de |
Locations
| Germany | |
| Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy | Recruiting |
| Marburg, Germany, 35037 | |
| Contact: Cornelia Exner, Prof. Dr. ++49 341 / 97 35 93 1 exnerc@uni-leipzig.de | |
| Principal Investigator: Cornelia Exner, Prof. Dr. | |
| Sub-Investigator: Nico Conrad, Dipl.-psych. | |
| Sub-Investigator: Bettina K. Doering, Dipl.-Psych. | |
| Sub-Investigator: Anna Kuenemund, Dipl.-Psych | |
| Sub-Investigator: Sarah Zwick, Dipl.-Psych. | |
| Psychotherapie-Ambulanz Marburg | Recruiting |
| Marburg, Germany | |
| Contact: Cornelia Exner, PD Dr. 064212826738 exnerc@staff.uni-marburg.de | |
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: | October 31, 2012 |
| 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 Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013