Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury

NCT00596765 | Completed

• 1 other identifier: NeuroPsy_Ex2007
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain Injury

Keywords

Brain Injury; Neuropsychology; Cognitive Behavioral Therapy; Neuropsychological Rehabilitation

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

• Quality of Life (Qolibri, Seiqol, SWLS)

  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

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

  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

• Psychopathology/ Affect (ADS; PANAS)

  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

• Community Integration (CIQ)

  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

Study Arms (2)

1

EXPERIMENTAL

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

2

OTHER

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

Interventions

Neuropsychological Cognitive Behavioral Therapy 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.

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philipps University Marburg: lead
• Psychotherapie-Ambulanz Marburg e.V.: collaborator

Study Sites (2)

Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy

Marburg, 35037, Germany

Location

Psychotherapie-Ambulanz Marburg

Marburg, Germany

Location

Related Links

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

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Cornelia Exner, Dr. (PhD)

  Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

  PRINCIPAL INVESTIGATOR

• Winfried Rief, Prof. Dr.

  Philipps University Marburg, Department of Clinical Psychology and Psychotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Winfried Rief

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: September 1, 2007
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

DE (2)