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

NCT ID: NCT01542957

Last Updated: 2017-03-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder Dysthymic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cognitive Behavioral + Dilemma Therapy

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

Group Type EXPERIMENTAL

Combined Cognitive Behavioral and Dilemma-Focused Therapy

Intervention Type BEHAVIORAL

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.

Cognitive Behavioral Therapy

Combined Group and Individual Cognitive Behavioral Therapy

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Depression

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Personal Construct Therapy Cognitive Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Distance Education University (UNED)

UNKNOWN

Sponsor Role collaborator

University of Minho

OTHER

Sponsor Role collaborator

University of Hertfordshire

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

University Ramon Llull

OTHER

Sponsor Role collaborator

Institut Trastorn Límit

UNKNOWN

Sponsor Role collaborator

Hospital de Mataró

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l

UNKNOWN

Sponsor Role collaborator

Associació Centre de Salut Mental Nou Barris

UNKNOWN

Sponsor Role collaborator

Fundacion IMIM

OTHER

Sponsor Role collaborator

EAP Poble Sec

UNKNOWN

Sponsor Role collaborator

Associació Catalana de Terapies Cognitives

UNKNOWN

Sponsor Role collaborator

Sant Pere Claver Fundació Sanitaria

UNKNOWN

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Dr. Guillem Feixas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillem Feixas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

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Hospital de Mataro (Consorci Sanitari del Maresme)

Mataró, Barcelona, Spain

Site Status

CAP Les Hortes

Barcelona, Catalonia, Spain

Site Status

Fundació Sanitària Sant Pere Claver

Barcelona, Catalonia, Spain

Site Status

Associació Catalana de Teràpies Cognitives

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 23683841 (View on PubMed)

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.

Reference Type RESULT
PMID: 27103215 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30543642 (View on PubMed)

Related Links

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http://www.ub.edu/terdep

Web page in Spanish and Catalan describing the research project and recruitment information

Other Identifiers

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PSI2011-23246

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

dilemma2012

Identifier Type: -

Identifier Source: org_study_id

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