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

Primary Purpose

Major Depressive Disorder, Dysthymic Disorder

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Combined Cognitive Behavioral and Dilemma-Focused Therapy
Cognitive Behavioral Therapy for Depression
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Dysthymic Disorder, Depression, Cognitive Behavior Therapy, Personal Construct Theory, Repertory Grid Technique, Cognitive Conflicts, Personal dilemmas

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Mataro (Consorci Sanitari del Maresme)
  • CAP Les Hortes
  • Fundació Sanitària Sant Pere Claver
  • Associació Catalana de Teràpies Cognitives

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral + Dilemma Therapy

Cognitive Behavioral Therapy

Arm Description

Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention

Combined Group and Individual Cognitive Behavioral Therapy

Outcomes

Primary Outcome Measures

Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 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.

Secondary Outcome Measures

Change From Baseline in Hamilton-Depression Rating Scale-17 Items
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
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.

Full Information

First Posted
February 26, 2012
Last Updated
February 17, 2017
Sponsor
University of Barcelona
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
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1. Study Identification

Unique Protocol Identification Number
NCT01542957
Brief Title
Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
Official Title
Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymic Disorder
Keywords
Major Depressive Disorder, Dysthymic Disorder, Depression, Cognitive Behavior Therapy, Personal Construct Theory, Repertory Grid Technique, Cognitive Conflicts, Personal dilemmas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral + Dilemma Therapy
Arm Type
Experimental
Arm Description
Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
Combined Group and Individual Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Combined Cognitive Behavioral and Dilemma-Focused Therapy
Other Intervention Name(s)
Personal Construct Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Depression
Other Intervention Name(s)
Cognitive Therapy
Intervention Description
Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
Primary Outcome Measure Information:
Title
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
Description
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.
Time Frame
End of therapy (16 weeks), 3 and 12-month follow-up
Secondary Outcome Measure Information:
Title
Change From Baseline in Hamilton-Depression Rating Scale-17 Items
Description
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.
Time Frame
End of therapy and 12-month follow-up
Title
Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
Description
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.
Time Frame
End of therapy, 3 and 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillem Feixas, Ph.D.
Organizational Affiliation
University of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Mataro (Consorci Sanitari del Maresme)
City
Mataro
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
Facility Name
CAP Les Hortes
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08004
Country
Spain
Facility Name
Fundació Sanitària Sant Pere Claver
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08004
Country
Spain
Facility Name
Associació Catalana de Teràpies Cognitives
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08032
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23683841
Citation
Feixas G, Bados A, Garcia-Grau E, Montesano A, Dada G, Compan V, Aguilera M, Salla M, Soldevilla JM, Trujillo A, Paz C, Botella L, Corbella S, Saul-Gutierrez LA, Canete J, Gasol M, Ibarra M, Medeiros-Ferreira L, Soriano J, Ribeiro E, Caspar F, Winter D. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial. Trials. 2013 May 17;14:144. doi: 10.1186/1745-6215-14-144.
Results Reference
background
PubMed Identifier
27103215
Citation
Feixas G, Bados A, Garcia-Grau E, Paz C, Montesano A, Compan V, Salla M, Aguilera M, Trujillo A, Canete J, Medeiros-Ferreira L, Soriano J, Ibarra M, Medina JC, Ortiz E, Lana F. A DILEMMA-FOCUSED INTERVENTION FOR DEPRESSION: A MULTICENTER, RANDOMIZED CONTROLLED TRIAL WITH A 3-MONTH FOLLOW-UP. Depress Anxiety. 2016 Sep;33(9):862-9. doi: 10.1002/da.22510. Epub 2016 Apr 22.
Results Reference
result
PubMed Identifier
30543642
Citation
Feixas G, Paz C, Garcia-Grau E, Montesano A, Medina JC, Bados A, Trujillo A, Ortiz E, Compan V, Salla M, Aguilera M, Guasch V, Codina J, Winter DA. One-year follow-up of a randomized trial with a dilemma-focused intervention for depression: Exploring an alternative to problem-oriented strategies. PLoS One. 2018 Dec 13;13(12):e0208245. doi: 10.1371/journal.pone.0208245. eCollection 2018.
Results Reference
derived
Links:
URL
http://www.ub.edu/terdep
Description
Web page in Spanish and Catalan describing the research project and recruitment information

Learn more about this trial

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

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