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Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.

This study has been terminated.
(Project end after 3 years; prolongation was rejected)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01039857
First Posted: December 25, 2009
Last Update Posted: July 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Swiss National Science Foundation
University Hospital Inselspital, Berne
Information provided by:
University of Bern
  Purpose
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.

Condition Intervention Phase
Adjustment Disorders Non-progressive Brain Injury Behavioral: Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy Behavioral: Integrative Neuro-Psychotherapy Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.

Further study details as provided by University of Bern:

Primary Outcome Measures:
  • 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 Measures:
  • 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) ]

Enrollment: 25
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Structured solution focused therapy
Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
Behavioral: Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
Experimental: Integrative clarification therapy
Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques
Behavioral: Integrative Neuro-Psychotherapy
Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039857


Locations
Switzerland
Bern University Hospital Dep. for Cognitive and Restorative Neurology
Bern, Switzerland, 3012
Sponsors and Collaborators
University of Bern
Swiss National Science Foundation
University Hospital Inselspital, Berne
Investigators
Study Chair: Hansjoerg Znoj, Prof. Dr. phil. University of Bern, Dep. of Clinical Psychology and Psychotherapy
Study Director: Helene Hofer, Dr. phil. Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Study Director: Martin Grosse Holtforth, Prof. Dr. phil. University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for Depression
Study Director: Rene M Mueri, Prof. Dr. med. Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
  More Information

Responsible Party: Prof. Dr. Hansjoerg Znoj, University of Bern, Department of Clinical Psychology and Psychotherapy
ClinicalTrials.gov Identifier: NCT01039857     History of Changes
Other Study ID Numbers: 012/08
100014-124574, 2009-2012 ( Other Grant/Funding Number: SNF )
1784 ( Other Identifier: Bern University Hospital )
First Submitted: December 24, 2009
First Posted: December 25, 2009
Last Update Posted: July 10, 2015
Last Verified: July 2015

Keywords provided by University of Bern:
Psychotherapy
Depression
Adjustment Disorders
Neuropsychology
Rehabilitation
Coping Skills
Stroke
Caregivers

Additional relevant MeSH terms:
Brain Injuries
Adjustment Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders
Pharmaceutical Solutions


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