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

This study is currently recruiting participants.
Verified February 2014 by University of Barcelona
Sponsor:
Collaborators:
National Distance Education University (UNED)
University of Minho
University of Hertfordshire
University of Bern
Ramon Llull University
Institut Trastorn Límit
Hospital de Mataró
Fundació Institut de Recerca de l
Associació Centre de Salut Mental Nou Barris
Fundacion IMIM
EAP Poble Sec
Associació Catalana de Terapies Cognitives
Sant Pere Claver Fundació Sanitaria
Information provided by (Responsible Party):
Dr. Guillem Feixas, University of Barcelona
ClinicalTrials.gov Identifier:
NCT01542957
First received: February 26, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Dysthymic Disorder
Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy
Behavioral: Cognitive Behavioral Therapy for Depression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention

Resource links provided by NLM:


Further study details as provided by University of Barcelona:

Primary Outcome Measures:
  • Change from Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the end of therapy [ Time Frame: End of therapy (16 weeks) ] [ Designated as safety issue: Yes ]
    To assess change in severity of depressive symptoms


Secondary Outcome Measures:
  • Change from baseline in Hamilton-Depression Rating Scale-17 items [ Time Frame: End of therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: November 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral + Dilemma Therapy
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Behavioral: 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.
Other Name: Personal Construct Therapy
Active Comparator: Cognitive Behavioral Therapy
Combined Group and Individual Cognitive Behavioral Therapy
Behavioral: 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.
Other Name: Cognitive Therapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542957

Contacts
Contact: Marta Salla, Ph.D. Cand. +34933125098 msallam@ub.edu
Contact: Olga Pucurull, Ph.D. Cand. +34933125809 opucurull@ub.edu

Locations
Spain
Hospital de Mataro (Consorci Sanitari del Maresme) Recruiting
Mataro, Barcelona, Spain, 08304
Contact: Josep Cañete, M.D.    +3493741700    jcanete@csdm.cat   
Contact: Cristina Martinez-Viana, Clin Psy    +3493741700    cmartinezvi@csdm.cat   
Principal Investigator: Josep Cañete, M.D.         
Sub-Investigator: Cristina Martinez-Viana, Clin Psy         
Associació Catalana de Teràpies Cognitives Recruiting
Barcelona, Catalonia, Spain, 08032
Contact: Maria Monini, MS in Psychology    +344568316    ctc@copc.cat   
Principal Investigator: Maria Monini         
Sub-Investigator: Gemma Borràz-Estruch, MS in Psychology         
Fundació Sanitària Sant Pere Claver Recruiting
Barcelona, Catalonia, Spain, 08004
Contact: Adriana Trujillo, Ph.D. student       trujilloadriana@ub.edu   
Sub-Investigator: Jordi Codina, Clinical Psychologist         
Sub-Investigator: Víctor Guasch, Psychiatrist         
CAP Les Hortes Recruiting
Barcelona, Catalonia, Spain, 08004
Contact: Lucia Garcia    +3493 324 91 00    uaau.eappoblesec@comb.cat   
Principal Investigator: Albert Broto, Physician         
Sub-Investigator: Francesc Vila Duart, Physician         
Sponsors and Collaborators
University of Barcelona
National Distance Education University (UNED)
University of Minho
University of Hertfordshire
University of Bern
Ramon Llull University
Institut Trastorn Límit
Hospital de Mataró
Fundació Institut de Recerca de l
Associació Centre de Salut Mental Nou Barris
Fundacion IMIM
EAP Poble Sec
Associació Catalana de Terapies Cognitives
Sant Pere Claver Fundació Sanitaria
Investigators
Principal Investigator: Guillem Feixas, Ph.D. University of Barcelona
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Guillem Feixas, Professor, University of Barcelona
ClinicalTrials.gov Identifier: NCT01542957     History of Changes
Other Study ID Numbers: dilemma2012, PSI2011-23246
Study First Received: February 26, 2012
Last Updated: February 7, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by University of Barcelona:
Major Depressive Disorder
Dysthymic Disorder
Depression
Cognitive Behavior Therapy
Personal Construct Theory
Repertory Grid Technique
Cognitive Conflicts
Personal dilemmas

Additional relevant MeSH terms:
Depression
Depressive Disorder
Dysthymic Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014