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

July 8, 2015 updated by: University of Bern
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.

Study Overview

Status

Terminated

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • Bern University Hospital Dep. for Cognitive and Restorative Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
after the first 10 sessions (Progress), end of therapy, 6 months after end of therapy (follow-up)

Secondary Outcome Measures

Outcome Measure
Time Frame
Acceptance measured by the Trier Skala zur Krankheitsverarbeitung (TSK)
Time Frame: end of therapy, 6 months after end of therapy (follow-up)
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)
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)
end of therapy, 6 months after end of therapy (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Collaborators

University Hospital Inselspital, Berne
Swiss National Science Foundation

Investigators

  • Study Chair: Hansjoerg Znoj, Prof. Dr. phil., University of Bern, Dep. of Clinical Psychology and Psychotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 24, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/08
  • 100014-124574, 2009-2012 (Other Grant/Funding Number: SNF)
  • 1784 (Bern University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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