Ignite Creation Date:
2024-05-05 @ 10:07 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01039857
Status:
TERMINATED
Last Update Posted:
2015-07-10
First Post:
2009-12-24
Brief Title:
Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients A Randomized Controlled Study
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients A Randomized Controlled Study
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Project end after 3 years prolongation was rejected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an intervention study with patients after a non-progressive brain injury who suffer from depression It will determine whether an integration of neuropsychological and psychotherapeutic techniques and an additional caregivers support program offers benefits to those in the process of coping with the effects of a stroke The investigators expect the integrative neuro-psychotherapy to be more effective in the treatment of emotional distress reactions following a stroke than the structured solution focused treatment
Detailed Description:
Background
A brain injury is one of the most common causes of disability acquired in adulthood The full extent of the impairment usually only becomes clear during the course of rehabilitation Apart from the emotional effects of dealing with the impairment it is also invariably a matter of adjusting to life with a disability In this phase of realization and coming to terms with their condition many brain-injured people develop a mental disorder mainly adjustment disorders with depressive andor anxiety symptoms Mental disorders related to adjustment are a significant and often limiting factor in patient rehabilitation While there is a very extensive body of literature on the diagnosis and treatment of cognitive disorders following a brain injury research on the diagnosis and treatment of clinical disorders following a brain injury is scarce There are many theoretical observations in the available literature about ways of dealing with adjustment disorders following a brain injury in order to maximize a patients rehabilitation outcome Yet current research based with randomized studies is still in its infancy The main aim of the current project is to close this scientific gap A key objective of the proposed study is to investigate whether an integration of neuropsychological and psychotherapeutic techniques and an additional caregivers support program offers benefits to those in the process of coping with the effects of a brain injury
It is expected that the integrative neuro-psychotherapy is more effective in the treatment of emotional distress reactions than the structured solution focused therapy Moreover a stronger improvement in acceptance awareness quality of life and goal attainment is anticipated in patients who receive the integrative neuro-psychotherapy treatment A correlation is expected of the extent of improvement and neuropsychological functional level in memory and executive functioning In addition the extent of improvement might depend on personality changes due to the stroke or on the location and volume of the lesion
Several measures will be used for patient assessment Demographic data will be collected MR or CT images will be made the National Institute of Health Stroke Scale NIHSS will be applied A comprehensive neuropsychological examination memory attention executive functioning and visual functioning will be performed with each patient before the beginning of the treatment Several questionnaires measuring depressive symptoms quality of life coping strategies awareness personality changes relationship and goals will be applied by patients caregivers and therapists depending on the questionnaire
Objective
A key objective of the proposed study is to investigate whether an integration of neuropsychological and psychotherapeutic techniques and an additional caregivers support program offers benefits to those in the process of coping with the effects of a non-progressive brain injury
Methods
This is a randomized controlled intervention study with two treatment arms the structured solution focused therapy and the integrative neuro-psychotherapy 20 face to face sessions will be held for each patient Primary caregivers will be supported by an online coaching tool Assessments will be made at baseline after 10 sessions progress after 20 sessions termination and at 6 months post treatment follow-up The hypothesis of statistically significant differences in the two groups will be tested by independent t-tests Moreover correlation tests will be applied to test post-hoc whether the extent of improvement measured by the BDI-II depends on the neuropsychological functional level in the cognitive area memory and executive functioning A lesion analysis and estimation of the lesion volume will be carried out post-hoc in order to test whether these factors do predict the effectiveness of the integrative neuro-psychotherapy
A brain injury is one of the most common causes of disability acquired in adulthood The full extent of the impairment usually only becomes clear during the course of rehabilitation Apart from the emotional effects of dealing with the impairment it is also invariably a matter of adjusting to life with a disability In this phase of realization and coming to terms with their condition many brain-injured people develop a mental disorder mainly adjustment disorders with depressive andor anxiety symptoms Mental disorders related to adjustment are a significant and often limiting factor in patient rehabilitation While there is a very extensive body of literature on the diagnosis and treatment of cognitive disorders following a brain injury research on the diagnosis and treatment of clinical disorders following a brain injury is scarce There are many theoretical observations in the available literature about ways of dealing with adjustment disorders following a brain injury in order to maximize a patients rehabilitation outcome Yet current research based with randomized studies is still in its infancy The main aim of the current project is to close this scientific gap A key objective of the proposed study is to investigate whether an integration of neuropsychological and psychotherapeutic techniques and an additional caregivers support program offers benefits to those in the process of coping with the effects of a brain injury
It is expected that the integrative neuro-psychotherapy is more effective in the treatment of emotional distress reactions than the structured solution focused therapy Moreover a stronger improvement in acceptance awareness quality of life and goal attainment is anticipated in patients who receive the integrative neuro-psychotherapy treatment A correlation is expected of the extent of improvement and neuropsychological functional level in memory and executive functioning In addition the extent of improvement might depend on personality changes due to the stroke or on the location and volume of the lesion
Several measures will be used for patient assessment Demographic data will be collected MR or CT images will be made the National Institute of Health Stroke Scale NIHSS will be applied A comprehensive neuropsychological examination memory attention executive functioning and visual functioning will be performed with each patient before the beginning of the treatment Several questionnaires measuring depressive symptoms quality of life coping strategies awareness personality changes relationship and goals will be applied by patients caregivers and therapists depending on the questionnaire
Objective
A key objective of the proposed study is to investigate whether an integration of neuropsychological and psychotherapeutic techniques and an additional caregivers support program offers benefits to those in the process of coping with the effects of a non-progressive brain injury
Methods
This is a randomized controlled intervention study with two treatment arms the structured solution focused therapy and the integrative neuro-psychotherapy 20 face to face sessions will be held for each patient Primary caregivers will be supported by an online coaching tool Assessments will be made at baseline after 10 sessions progress after 20 sessions termination and at 6 months post treatment follow-up The hypothesis of statistically significant differences in the two groups will be tested by independent t-tests Moreover correlation tests will be applied to test post-hoc whether the extent of improvement measured by the BDI-II depends on the neuropsychological functional level in the cognitive area memory and executive functioning A lesion analysis and estimation of the lesion volume will be carried out post-hoc in order to test whether these factors do predict the effectiveness of the integrative neuro-psychotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 100014-124574 2009-2012 | OTHER_GRANT | None | None |
| 1784 | OTHER | Bern University Hospital | None |