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Completed

NCT Number: NCT00596765

Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy, Marburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Psychotherapie-Ambulanz Marburg e.V.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2014
Study completion
2015
First posted
Jan 17, 2008
Registry last updated
May 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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