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

This study has been completed.
Sponsor:
Collaborators:
National Distance Education University (UNED)
University of Minho
University of Hertfordshire
University of Bern
University Ramon Llull
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: June 1, 2015
Last verified: June 2015
  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

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 ]

Enrollment: 128
Study Start Date: November 2011
Study Completion Date: May 2015
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Hospital de Mataro (Consorci Sanitari del Maresme)
Mataro, Barcelona, Spain, 08304
Associació Catalana de Teràpies Cognitives
Barcelona, Catalonia, Spain, 08032
CAP Les Hortes
Barcelona, Catalonia, Spain, 08004
Fundació Sanitària Sant Pere Claver
Barcelona, Catalonia, Spain, 08004
Sponsors and Collaborators
University of Barcelona
National Distance Education University (UNED)
University of Minho
University of Hertfordshire
University of Bern
University Ramon Llull
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: June 1, 2015
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
Depressive Disorder, Major
Disease
Dysthymic Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2015