Adjustment DisordersPhase 1NCT01039857
Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.
A Phase 1 study testing Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy and Integrative Neuro-Psychotherapy in people with Adjustment Disorders and Non-progressive Brain Injury, run by University of Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Adjustment Disorders, Non-progressive Brain Injury
- What is being tested?
- Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy and Integrative Neuro-Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 1
- 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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University Hospital Dep. for Cognitive and Restorative Neurology
Bern, 3012
About this study
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.
Read the 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.
- Conditions
- Adjustment Disorders, Non-progressive Brain Injury
- Being tested
- Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy, Integrative Neuro-Psychotherapy
- Keywords
- Psychotherapy, Depression, Adjustment Disorders, Neuropsychology, Rehabilitation, Coping Skills, Stroke, Caregivers
- Medical subject headings
- Adjustment Disorders, Depression, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapyBehavioural
Integrative Neuro-PsychotherapyBehavioural
Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques
| Study group | Role | What they receive |
|---|---|---|
| Structured solution focused therapy | Other | Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy Receives: Behavioral: Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy |
| Integrative clarification therapy | Experimental | Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques Receives: Behavioral: Integrative Neuro-Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
emotional distress measured by the Beck Depression Inventory (BDI-II)
Measured: after the first 10 sessions (Progress), end of therapy, 6 months after end of therapy (follow-up)
Secondary outcomes (3)
Acceptance measured by the Trier Skala zur Krankheitsverarbeitung (TSK)
Measured: end of therapy, 6 months after end of therapy (follow-up)
Awareness measured by the Awareness Questionnaire
Measured: end of therapy, 6 months after end of therapy (follow-up)
Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Measured: end of therapy, 6 months after end of therapy (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionDec 2013
Why it stopped: Project end after 3 years; prolongation was rejected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjustment DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern
- Investigators
- Hansjoerg Znoj, Prof. Dr. phil., Study chair, University of Bern, Dep. of Clinical Psychology and PsychotherapyHelene Hofer, Dr. phil., Study director, Bern University Hospital, Outpatient Clinic for Cognitive and Restorative NeurologyMartin Grosse Holtforth, Prof. Dr. phil., Study director, University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for DepressionRene M Mueri, Prof. Dr. med., Study director, Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039857
- Sponsor's protocol ID
- 012/08
- Other IDs
- 100014-124574, 2009-2012, 1784
- Status last verified
- Jul 2015
- First submitted
- 24 Dec 2009
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT01039857
- Acronym / sponsor ID
- 012/08
- Conditions
- Adjustment Disorders, Non-progressive Brain Injury
- Keywords
- Psychotherapy, Depression, Adjustment Disorders, Neuropsychology, Rehabilitation, Coping Skills, Stroke, Caregivers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project end after 3 years; prolongation was rejected
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Dec 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured solution focused therapy | Other | Behavioral: Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapyNeuropsychological Therapy, cognitive behavioral therapy, solution focused therapy |
| Integrative clarification therapy | Experimental | Behavioral: Integrative Neuro-PsychotherapyNeuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 Therapy, cognitive behavioral therapy, solution focused therapy | Behavioural | Structured solution focused therapy |
| Integrative Neuro-PsychotherapyNeuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques | Behavioural | Integrative clarification therapy |
Primary outcome
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)
3 secondary outcomes
Acceptance measured by the Trier Skala zur Krankheitsverarbeitung (TSK)
Time frame: end of therapy, 6 months after end of therapy (follow-up)
Awareness measured by the Awareness Questionnaire
Time frame: end of therapy, 6 months after end of therapy (follow-up)
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)
Results and safety
The study was stopped early (reason given: Project end after 3 years; prolongation was rejected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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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.
Hansjoerg Znoj, Prof. Dr. phil. study chair
University of Bern, Dep. of Clinical Psychology and Psychotherapy
Helene Hofer, Dr. phil. study director
Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Martin Grosse Holtforth, Prof. Dr. phil. study director
University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for Depression
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy and Integrative Neuro-Psychotherapy in people with Adjustment Disorders and Non-progressive Brain Injury, run by University of Bern at 1 site in Switzerland.
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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Project end after 3 years; prolongation was rejected). Results are not available in the source record.
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?
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)). 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 10 Jul 2015.