Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
2 other identifiers
interventional
128
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Nov 2011
Typical duration for not_applicable major-depressive-disorder
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
December 19, 2016
CompletedMarch 22, 2017
February 1, 2017
3 years
February 26, 2012
October 25, 2016
February 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
End of therapy (16 weeks), 3 and 12-month follow-up
Secondary Outcomes (2)
Change From Baseline in Hamilton-Depression Rating Scale-17 Items
End of therapy and 12-month follow-up
Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
End of therapy, 3 and 12 month follow-up
Study Arms (2)
Cognitive Behavioral + Dilemma Therapy
EXPERIMENTALCombines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention
Cognitive Behavioral Therapy
ACTIVE COMPARATORCombined Group and Individual Cognitive Behavioral Therapy
Interventions
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 for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Bipolar disorders
- Psychotic symptoms
- Substance abuse
- Organic brain dysfunction
- Mental retardation
- Serious suicidal ideation
- Substantial visual, hearing or cognitive deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Barcelonalead
- National Distance Education University (UNED)collaborator
- University of Minhocollaborator
- University of Hertfordshirecollaborator
- University of Berncollaborator
- University Ramon Llullcollaborator
- Institut Trastorn Límitcollaborator
- Hospital de Matarócollaborator
- Fundació Institut de Recerca de lcollaborator
- Associació Centre de Salut Mental Nou Barriscollaborator
- Fundacion IMIMcollaborator
- EAP Poble Seccollaborator
- Associació Catalana de Terapies Cognitivescollaborator
- Sant Pere Claver Fundació Sanitariacollaborator
Study Sites (4)
Hospital de Mataro (Consorci Sanitari del Maresme)
Mataró, Barcelona, 08304, Spain
CAP Les Hortes
Barcelona, Catalonia, 08004, Spain
Fundació Sanitària Sant Pere Claver
Barcelona, Catalonia, 08004, Spain
Associació Catalana de Teràpies Cognitives
Barcelona, Catalonia, 08032, Spain
Related Publications (3)
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.
PMID: 23683841BACKGROUNDFeixas 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.
PMID: 27103215RESULTFeixas 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.
PMID: 30543642DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Guillem Feixas
- Organization
- Universitat de Barcelona
Study Officials
- PRINCIPAL INVESTIGATOR
Guillem Feixas, Ph.D.
University of Barcelona
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 26, 2012
First Posted
March 2, 2012
Study Start
November 1, 2011
Primary Completion
November 1, 2014
Study Completion
May 1, 2015
Last Updated
March 22, 2017
Results First Posted
December 19, 2016
Record last verified: 2017-02