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

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ClinicalTrials.gov Identifier: NCT01542957
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : December 19, 2016
Last Update Posted : March 22, 2017
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

Tracking Information
First Submitted Date  ICMJE February 26, 2012
First Posted Date  ICMJE March 2, 2012
Results First Submitted Date  ICMJE October 25, 2016
Results First Posted Date  ICMJE December 19, 2016
Last Update Posted Date March 22, 2017
Study Start Date  ICMJE November 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy [ Time Frame: End of therapy (16 weeks) ]
To assess change in severity of depressive symptoms
Change History Complete list of historical versions of study NCT01542957 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
  • Change From Baseline in Hamilton-Depression Rating Scale-17 Items [ Time Frame: 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.
  • Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
Official Title  ICMJE Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Dysthymic Disorder
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral + Dilemma Therapy
    Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
    Intervention: Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy
  • Active Comparator: Cognitive Behavioral Therapy
    Combined Group and Individual Cognitive Behavioral Therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy for Depression
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2015)
128
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2012)
112
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01542957
Other Study ID Numbers  ICMJE dilemma2012
PSI2011-23246 ( Other Grant/Funding Number: Ministry of Science and Innovation (Spanish Government) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Guillem Feixas, University of Barcelona
Study Sponsor  ICMJE University of Barcelona
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Guillem Feixas, Ph.D. University of Barcelona
PRS Account University of Barcelona
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP