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Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury

Primary Purpose

Brain Injury

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Neuropsychological Cognitive Behavioral Therapy

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring Brain Injury, Neuropsychology, Cognitive Behavioral Therapy, Neuropsychological Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy
Psychotherapie-Ambulanz Marburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Psychosocial Adjustment/ Everyday Functioning as a composite score of SCL-90-R and AFIB

Secondary Outcome Measures

Quality of Life (Qolibri, Seiqol, SWLS)

Self-concept/ Life Goals (HISDS II; GOALS; RSES-REV; Self-complexity Measure; FSKN)

Psychopathology/ Affect (ADS; PANAS)

Community Integration (CIQ)

Full Information

NCT ID

NCT00596765

First Posted

January 8, 2008

Last Updated

May 24, 2016

Sponsor

Philipps University Marburg Medical Center

Collaborators

Psychotherapie-Ambulanz Marburg e.V.

1. Study Identification

Unique Protocol Identification Number

NCT00596765

Brief Title

Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Philipps University Marburg Medical Center

Collaborators

Psychotherapie-Ambulanz Marburg e.V.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injury

Keywords

Brain Injury, Neuropsychology, Cognitive Behavioral Therapy, Neuropsychological Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Neuropsychological Cognitive Behavioral Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cornelia Exner, Dr. (PhD)

Organizational Affiliation

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Winfried Rief, Prof. Dr.

Organizational Affiliation

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

Official's Role

Study Director

Facility Information:

Facility Name

Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Psychotherapie-Ambulanz Marburg

City

Marburg

Country

Germany

12. IPD Sharing Statement

Links:

URL

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

Description

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

Learn more about this trial

Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury

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