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Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention

17. februar 2017 oppdatert av: Dr. Guillem Feixas, University of Barcelona
The purpose of this study is to determine the efficacy of a brief psychological intervention focused on the personal dilemmas identified for each depressive patient. For that, this intervention is combined to group cognitive therapy (an already proven efficacious format) and compared to cognitive individual therapy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments most of the cases evolve with only partial remission, relapse and recurrence.

Cognitive models made a significant contribution in the understanding of unipolar depression and its psychological treatment. Even though, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence.

Our research group has been working in the notion of cognitive conflict viewed as personal dilemma according to personal construct theory. The investigators use a novel method for identifying those conflicts using the repertory grid technique. Preliminary results with depressive patients show that more than 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused in the resolution of these internal conflicts.

This study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will contribute to enhance the efficacy of Cognitive-Behavioral Therapy for depression. A therapy manual for this approach will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: a CBT treatment package and another package combining cognitive-behavioral and dilemma-focused interventions. The investigators expect that this combined package will increase the efficacy of CBT, one of the more prestigious therapies for depression, this resulting in a significant contribution for its treatment.

Studietype

Intervensjonell

Registrering (Faktiske)

128

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
    • Barcelona
      • Mataro, Barcelona, Spania, 08304
        • Hospital de Mataro (Consorci Sanitari del Maresme)
    • Catalonia
      • Barcelona, Catalonia, Spania, 08004
        • CAP Les Hortes
      • Barcelona, Catalonia, Spania, 08004
        • Fundació Sanitària Sant Pere Claver
      • Barcelona, Catalonia, Spania, 08032
        • Associació Catalana de Teràpies Cognitives

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Meeting diagnostic criteria for Major Depressive Disorder (MDD) or Dysthymic Disorder (DD) according to the DSM-IV-TR (APA, 2002) criteria a assessed using SCID-I
  • A score above 19 on the BDI-II Questionnaire
  • Presenting at leat one cognitive conflict (implicative dilemma or dilemmatic construct) as assessed using the Repertory Grid Technique
  • Enough level of competence to communicate in Spanish or Catalan

Exclusion Criteria:

  • Bipolar disorders
  • Psychotic symptoms
  • Substance abuse
  • Organic brain dysfunction
  • Mental retardation
  • Serious suicidal ideation
  • Receiving psychological treatment (unless it is suspended at the time of inclusion in the study itself, in agreement with the patient and the practitioner applying it)
  • Substantial visual, hearing or cognitive deficits

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cognitive Behavioral + Dilemma Therapy
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Atferdsmessig: Combined Cognitive Behavioral and Dilemma-Focused Therapy
7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.
Andre navn:
  • Personal Construct Therapy
Aktiv komparator: Cognitive Behavioral Therapy
Combined Group and Individual Cognitive Behavioral Therapy
Atferdsmessig: Cognitive Behavioral Therapy for Depression
Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
Andre navn:
  • Kognitiv terapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
Tidsramme: End of therapy (16 weeks), 3 and 12-month follow-up
To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.
End of therapy (16 weeks), 3 and 12-month follow-up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Hamilton-Depression Rating Scale-17 Items
Tidsramme: End of therapy and 12-month follow-up
This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.
End of therapy and 12-month follow-up
Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
Tidsramme: End of therapy, 3 and 12 month follow-up
To assess subjective well-being, symptoms or problems, life functioning, and risk. The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34). The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.
End of therapy, 3 and 12 month follow-up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Barcelona

Samarbeidspartnere

University of Minho
University of Bern
University of Hertfordshire
Hospital de Mataró
University Ramon Llull
Fundacion IMIM
National Distance Education University (UNED)
Institut Trastorn Límit
Fundació Institut de Recerca de l
Associació Centre de Salut Mental Nou Barris
EAP Poble Sec
Associació Catalana de Terapies Cognitives
Sant Pere Claver Fundació Sanitaria

Etterforskere

  • Hovedetterforsker: Guillem Feixas, Ph.D., University of Barcelona

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2011

Primær fullføring (Faktiske)

1. november 2014

Studiet fullført (Faktiske)

1. mai 2015

Datoer for studieregistrering

Først innsendt

26. februar 2012

Først innsendt som oppfylte QC-kriteriene

1. mars 2012

Først lagt ut (Anslag)

2. mars 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. februar 2017

Sist bekreftet

1. februar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • dilemma2012
  • PSI2011-23246 (Annet stipend/finansieringsnummer: Ministry of Science and Innovation (Spanish Government))

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