Clinical trial NCT00596765: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Keywords: Brain Injury
Neuropsychology
Cognitive Behavioral Therapy
Neuropsychological Rehabilitation
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Psychotherapie-Ambulanz Marburg e.V.
First posted: 2008-01-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Psychosocial Adjustment/ Everyday Functioning as a composite score of SCL-90-R and AFIB
timeFrame: 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:
measure: Quality of Life (Qolibri, Seiqol, SWLS)
timeFrame: 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
measure: Self-concept/ Life Goals (HISDS II; GOALS; RSES-REV; Self-complexity Measure; FSKN)
timeFrame: 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
measure: Psychopathology/ Affect (ADS; PANAS)
timeFrame: 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
measure: Community Integration (CIQ)
timeFrame: 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
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy
city: Marburg
country: Germany
facility: Psychotherapie-Ambulanz Marburg
Study officials:
affiliation: Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
name: Cornelia Exner, Dr. (PhD)
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
name: Winfried Rief, Prof. Dr.
role: STUDY_DIRECTOR
References: