Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury

NCT ID: NCT00596765

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Neuropsychological Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Neuropsychological Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psychotherapie-Ambulanz Marburg e.V.

OTHER

Sponsor Role collaborator

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Winfried Rief

Prof. Dr. Winfried Rief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cornelia Exner, Dr. (PhD)

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Winfried Rief, Prof. Dr.

Role: STUDY_DIRECTOR

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Locations

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Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy

Marburg, , Germany

Site Status

Psychotherapie-Ambulanz Marburg

Marburg, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.psychotherapie-ambulanz-marburg.de/FrameSets/fsForschung.html

Click here for more information about this study: "Selbständig leben nach einer Hirnschädigung"

Other Identifiers

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NeuroPsy_Ex2007

Identifier Type: -

Identifier Source: org_study_id

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