NCT01039857

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

2.6 years

First QC Date

December 24, 2009

Last Update Submit

July 8, 2015

Conditions

Adjustment DisordersNon-progressive Brain Injury

Keywords

PsychotherapyDepressionAdjustment DisordersNeuropsychologyRehabilitationCoping SkillsStrokeCaregivers

Outcome Measures

Primary Outcomes (1)

  • emotional distress measured by the Beck Depression Inventory (BDI-II)

    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)

    end of therapy, 6 months after end of therapy (follow-up)

  • Awareness measured by the Awareness Questionnaire

    end of therapy, 6 months after end of therapy (follow-up)

  • Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)

    end of therapy, 6 months after end of therapy (follow-up)

Study Arms (2)

Structured solution focused therapy

OTHER

Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy

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

Behavioral: Integrative Neuro-Psychotherapy

Interventions

Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapyBEHAVIORAL
Structured solution focused therapy
Integrative Neuro-PsychotherapyBEHAVIORAL

Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques

Integrative clarification therapy

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University Hospital Dep. for Cognitive and Restorative Neurology

Bern, 3012, Switzerland

Location

MeSH Terms

Conditions

Adjustment DisordersDepressionStroke

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hansjoerg Znoj, Prof. Dr. phil.

    University of Bern, Dep. of Clinical Psychology and Psychotherapy

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 24, 2009

First Posted

December 25, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2012

Study Completion

December 1, 2013

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

CH(1)