- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00211835
Treatment of Post-TBI Depression
Treatment of Post-TBI Depression - A Randomized Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10029-6574
- Icahn School of Medicine at Mount Sinai
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Remission of depression (DSM-IV diagnosis no longer met)
Délai: baseline
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baseline
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Remission of depression (DSM-IV diagnosis no longer met)
Délai: 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)
Délai: 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)
Délai: one year after treatment completion
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one year after treatment completion
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Increased participation (Participation Objective, Participation Subjective)
Délai: baseline
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baseline
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Improved quality of life (Life-3).
Délai: baseline
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baseline
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Increased participation (Participation Objective, Participation Subjective)
Délai: one week after treatment completion
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one week after treatment completion
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Increased participation (Participation Objective, Participation Subjective)
Délai: six months after treatment completion
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six months after treatment completion
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Increased participation (Participation Objective, Participation Subjective)
Délai: one year after treatment completion
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one year after treatment completion
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Improved quality of life (Life-3).
Délai: one week after treatment completion
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one week after treatment completion
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Improved quality of life (Life-3).
Délai: six months after treatment completion
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six months after treatment completion
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Improved quality of life (Life-3).
Délai: one year after treatment completion
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one year after treatment completion
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Wayne Gordon, Ph.D., Icahn School of Medicine at Mount Sinai
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Symptômes comportementaux
- Les troubles mentaux
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Troubles de l'humeur
- Blessures et Blessures
- Traumatisme crânio-cérébral
- Traumatisme, système nerveux
- La dépression
- Dépression
- Lésions cérébrales
- Lésions cérébrales, traumatiques
Autres numéros d'identification d'étude
- GCO 04-0782
- H133B040033
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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