Brain InjuryNCT00596765
Neuropsychological Cognitive Behavioral Therapy for Patients With Acquired Brain Injury
A study testing Neuropsychological Cognitive Behavioral Therapy in people with Brain Injury, run by Philipps University Marburg at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- Neuropsychological Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2007to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Philipps University Marburg, Departement of Clinical Psychology and Psychotherapy
Marburg, 35037
Psychotherapie-Ambulanz Marburg
Marburg
About this study
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
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.
Read the 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.
- Conditions
- Brain Injury
- Being tested
- Neuropsychological Cognitive Behavioral Therapy
- Keywords
- Brain Injury, Neuropsychology, Cognitive Behavioral Therapy, Neuropsychological Rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological Cognitive Behavioral TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Neuropsychological Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial Adjustment/ Everyday Functioning as a composite score of SCL-90-R and AFIB
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- Psychotherapie-Ambulanz Marburg e.V.
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
- Investigators
- Cornelia Exner, Dr. (PhD), Principal investigator, Philipps University Marburg, Department of Clinical Psychology and PsychotherapyWinfried Rief, Prof. Dr., Study director, Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596765
- Sponsor's protocol ID
- NeuroPsy_Ex2007
- Status last verified
- May 2016
- First submitted
- 8 Jan 2008
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00596765
- Acronym / sponsor ID
- NeuroPsy_Ex2007
- Conditions
- Brain Injury
- Keywords
- Brain Injury, Neuropsychology, Cognitive Behavioral Therapy, Neuropsychological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- Psychotherapie-Ambulanz Marburg e.V.
- Study start
- Sep 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Neuropsychological Cognitive Behavioral TherapyNeuropsychological 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). |
| 2 | Other | Behavioral: Neuropsychological Cognitive Behavioral TherapyWaiting 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological Cognitive Behavioral TherapyNeuropsychological 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. | Behavioural | 1, 2 |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Click here for more information about this study: "Selbständig leben nach einer Hirnschädigung"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia Exner, Dr. (PhD) principal investigator
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
Winfried Rief, Prof. Dr. study director
Philipps University Marburg, Department of Clinical Psychology and Psychotherapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological Cognitive Behavioral Therapy in people with Brain Injury, run by Philipps University Marburg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.