Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.
Primary Purpose
Adjustment Disorders, Non-progressive Brain Injury
Status
Terminated
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
Integrative Neuro-Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Adjustment Disorders focused on measuring Psychotherapy, Depression, Adjustment Disorders, Neuropsychology, Rehabilitation, Coping Skills, Stroke, Caregivers
Eligibility Criteria
Inclusion Criteria:
- Non-progressive acquired brain injury
- Time passed since brain injury equal or more than 4 months
- Sufficient language ability to communicate and understand
- Sufficient language ability in German
- Currently in an outpatient setting
- Diagnosis of an adjustment disorder (DSM-IV: 309.x, acute or chronic)
- Age between 18 and 66 years
Exclusion Criteria
- Events other than non-progressive acquired brain injury (e.g. neurodegenerative illness)
- Presence of other chronic diseases (e.g. multiple sclerosis, sarcoidosis, Parkinson disorder, chronic pain disorder, rheumatic disorder)
- Moderate to severe cognitive impairment
- Prior history of psychiatric disease such as alcohol and drug abuse, personality disorders, obsessive-compulsive disorder, psychotic disorder
- Suicidal or violent behaviour
Sites / Locations
- Bern University Hospital Dep. for Cognitive and Restorative Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Structured solution focused therapy
Integrative clarification therapy
Arm Description
Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques
Outcomes
Primary Outcome Measures
emotional distress measured by the Beck Depression Inventory (BDI-II)
Secondary Outcome Measures
Acceptance measured by the Trier Skala zur Krankheitsverarbeitung (TSK)
Awareness measured by the Awareness Questionnaire
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Full Information
NCT ID
NCT01039857
First Posted
December 24, 2009
Last Updated
July 8, 2015
Sponsor
University of Bern
Collaborators
Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT01039857
Brief Title
Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.
Official Title
Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Project end after 3 years; prolongation was rejected
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bern
Collaborators
Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 and/or 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 patient's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjustment Disorders, Non-progressive Brain Injury
Keywords
Psychotherapy, Depression, Adjustment Disorders, Neuropsychology, Rehabilitation, Coping Skills, Stroke, Caregivers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Structured solution focused therapy
Arm Type
Other
Arm Description
Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
Arm Title
Integrative clarification therapy
Arm Type
Experimental
Arm Description
Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
Intervention Type
Behavioral
Intervention Name(s)
Integrative Neuro-Psychotherapy
Intervention Description
Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques
Primary Outcome Measure Information:
Title
emotional distress measured by the Beck Depression Inventory (BDI-II)
Time Frame
after the first 10 sessions (Progress), end of therapy, 6 months after end of therapy (follow-up)
Secondary Outcome Measure Information:
Title
Acceptance measured by the Trier Skala zur Krankheitsverarbeitung (TSK)
Time Frame
end of therapy, 6 months after end of therapy (follow-up)
Title
Awareness measured by the Awareness Questionnaire
Time Frame
end of therapy, 6 months after end of therapy (follow-up)
Title
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Time Frame
end of therapy, 6 months after end of therapy (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-progressive acquired brain injury
Time passed since brain injury equal or more than 4 months
Sufficient language ability to communicate and understand
Sufficient language ability in German
Currently in an outpatient setting
Diagnosis of an adjustment disorder (DSM-IV: 309.x, acute or chronic)
Age between 18 and 66 years
Exclusion Criteria
Events other than non-progressive acquired brain injury (e.g. neurodegenerative illness)
Presence of other chronic diseases (e.g. multiple sclerosis, sarcoidosis, Parkinson disorder, chronic pain disorder, rheumatic disorder)
Moderate to severe cognitive impairment
Prior history of psychiatric disease such as alcohol and drug abuse, personality disorders, obsessive-compulsive disorder, psychotic disorder
Suicidal or violent behaviour
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hansjoerg Znoj, Prof. Dr. phil.
Organizational Affiliation
University of Bern, Dep. of Clinical Psychology and Psychotherapy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helene Hofer, Dr. phil.
Organizational Affiliation
Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Grosse Holtforth, Prof. Dr. phil.
Organizational Affiliation
University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for Depression
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rene M Mueri, Prof. Dr. med.
Organizational Affiliation
Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Official's Role
Study Director
Facility Information:
Facility Name
Bern University Hospital Dep. for Cognitive and Restorative Neurology
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.
We'll reach out to this number within 24 hrs