Clinical trial NCT01542957: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: National Distance Education University (UNED)
name: University of Minho
name: University of Hertfordshire
name: University of Bern
name: University Ramon Llull
name: Institut Trastorn Límit
name: Hospital de Mataró
name: Fundació Institut de Recerca de l
name: Associació Centre de Salut Mental Nou Barris
name: Fundacion IMIM
name: EAP Poble Sec
name: Associació Catalana de Terapies Cognitives
name: Sant Pere Claver Fundació Sanitaria
First posted: 2012-03-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up
timeFrame: End of therapy (16 weeks), 3 and 12-month follow-up
Secondary outcomes:
measure: Change From Baseline in Hamilton-Depression Rating Scale-17 Items
timeFrame: End of therapy and 12-month follow-up
measure: Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up
timeFrame: End of therapy, 3 and 12 month follow-up
Other outcomes:
Locations:
city: Mataro
country: Spain
facility: Hospital de Mataro (Consorci Sanitari del Maresme)
state: Barcelona
city: Barcelona
country: Spain
facility: CAP Les Hortes
state: Catalonia
city: Barcelona
country: Spain
facility: Fundació Sanitària Sant Pere Claver
state: Catalonia
city: Barcelona
country: Spain
facility: Associació Catalana de Teràpies Cognitives
state: Catalonia
Study officials:
affiliation: University of Barcelona
name: Guillem Feixas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.