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- Klinische proef NCT00211835
Treatment of Post-TBI Depression
Treatment of Post-TBI Depression - A Randomized Clinical Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Goals Demonstrate the efficacy of cognitive behavioral therapy (CBT), both immediately after treatment and in the long term, in alleviating post-TBI depression.
Examine the relationship between improved mood, participation, and life satisfaction.
Implement exploratory analyses of the relationships between person and injury characteristics and outcomes of treatment.
Maximize potential application to clinical practice by:
Implementing the treatment in a clinical context so that its utility is demonstrated in a setting that maximizes ecological validity, and Creating and disseminating a manual detailing CBT treatment. This study is a randomized clinical trial that compares two treatment conditions: CBT and supportive psychotherapy (SPT). CBT has been shown to be effective in diverse studies. In this study, CBT has been shaped to be used specifically with people with typical post-TBI cognitive challenges. All participants will be given an opportunity to immediately receive a randomly assigned psychotherapy intervention to potentially enhance coping. Both CBT and SPT will involve 16 sessions of individual treatment. The initial session will be 90 minutes, with remaining sessions 50 minutes. In both treatments, participants will be seen for three months, with sessions twice weekly for the first month and once a week subsequently. The research assistants who will administer pre- and postintervention evaluation instruments will be blind to each participant's randomly assigned treatment condition. Evaluation instruments will be administered at baseline and at three points of follow-up: one week, six months, and one year after treatment. A detailed manual describing treatment methods will be developed based on the intervention.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10029-6574
- Icahn School of Medicine at Mount Sinai
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Being at least 18years old
- Having a TBI as a result of a blow to the head followed by a loss of consciousness or period of being dazed and confused or a period of post traumatic amnesia or clinical signs of altered neurological function; this information must be medically documented (e.g., emergency medical record, hospital record, neuroradiological report, or neurological exam or record of physician's visit within 24 hours of injury)
- Being at least 6 months post injury
- Being English-speaking
- Having residential telephone service
- Living within 1.5 hours of New York City
- Having at least a sixth-grade reading level
- Meeting DSM-IV criteria for a current depressive mood disorder
- Not being in psychotherapy and being willing to abstain from seeking psychotherapy during the course of participation
- Being willing to complete questionnaires and interviews about mood, thinking skills, community participation and life satisfaction
- Agreeing to participate, verified by completion of informed consent and HIPAA documents.
- Individuals who meet criteria and are currently using prescribed mood medications will be included in the study if dosage has been stable for sixty days.
Exclusion Criteria:
- Pre-existing neurological disorder, including brain injury from an etiology other than trauma
- History of mental retardation
- Lack of capacity to sign informed consent
- Taking antidepressant medications for less than six months
- Having any changes in antidepressant medications in the last six months
- History of current or past psychosis or mania
- Current substance abuse
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Treatment Arm 1
Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood.
The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression.
CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
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Individual psychotherapy focused on identifying and correcting maladaptive cognitions and behaviors with the goal of improving mood.
The intervention has adapted CBT specifically to address cognitive deficits associated with TBI, which compound the cognitive distortions typical of depression.
CBT therapists embed compensatory strategies within treatment sessions to address cognitive limitations of each participant.
|
Experimenteel: Treatment Arm 2
A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI.
In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.
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A client-centered individual psychotherapy treatment approach designed to address depressive disorders commonly experienced by individuals following a TBI.
In line with traditional supportive psychotherapy approaches, the objective of SPT is to improve the individual's ability to deal with problems of daily living more effectively through problem identification, praise, reassurance, encouragement, psychoeducation, advice, anticipatory guidance, and expanding awareness.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Remission of depression (DSM-IV diagnosis no longer met)
Tijdsspanne: baseline
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baseline
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Remission of depression (DSM-IV diagnosis no longer met)
Tijdsspanne: one week after treatment completion
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one week after treatment completion
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Remission of depression (DSM-IV diagnosis no longer met)
Tijdsspanne: six months after treatment completion
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six months after treatment completion
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Remission of depression (DSM-IV diagnosis no longer met)
Tijdsspanne: one year after treatment completion
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one year after treatment completion
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Increased participation (Participation Objective, Participation Subjective)
Tijdsspanne: baseline
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baseline
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Improved quality of life (Life-3).
Tijdsspanne: baseline
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baseline
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Increased participation (Participation Objective, Participation Subjective)
Tijdsspanne: one week after treatment completion
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one week after treatment completion
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Increased participation (Participation Objective, Participation Subjective)
Tijdsspanne: six months after treatment completion
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six months after treatment completion
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Increased participation (Participation Objective, Participation Subjective)
Tijdsspanne: one year after treatment completion
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one year after treatment completion
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Improved quality of life (Life-3).
Tijdsspanne: one week after treatment completion
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one week after treatment completion
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Improved quality of life (Life-3).
Tijdsspanne: six months after treatment completion
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six months after treatment completion
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Improved quality of life (Life-3).
Tijdsspanne: one year after treatment completion
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one year after treatment completion
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Wayne Gordon, Ph.D., Icahn School of Medicine at Mount Sinai
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GCO 04-0782
- H133B040033
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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