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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Dysthymic Disorder
• Intervention / Treatment: Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy; Behavioral: Cognitive Behavioral Therapy for Depression

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: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mataro, Barcelona, Spain, 08304
      • Hospital de Mataro (Consorci Sanitari del Maresme)
  • Catalonia
    • Barcelona, Catalonia, Spain, 08004
      • CAP Les Hortes
    • Barcelona, Catalonia, Spain, 08004
      • Fundació Sanitària Sant Pere Claver
    • Barcelona, Catalonia, Spain, 08032
      • Associació Catalana de Teràpies Cognitives

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral + Dilemma Therapy; Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention	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 Names: Personal Construct Therapy
Active Comparator: Cognitive Behavioral Therapy; Combined Group and Individual Cognitive Behavioral 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 Names: Cognitive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	End of therapy, 3 and 12 month follow-up

Collaborators and Investigators

• Sponsor: University of Barcelona
• Collaborators: University of Minho; University of Bern; University of Hertfordshire; Hospital de Mataró; University Ramon Llull; Fundacion IMIM; National Distance Education University (UNED); Institut Trastorn Límit; Fundació Institut de Recerca de l; Associació Centre de Salut Mental Nou Barris; EAP Poble Sec; Associació Catalana de Terapies Cognitives; Sant Pere Claver Fundació Sanitaria
• Investigators: Principal Investigator: Guillem Feixas, Ph.D., University of Barcelona

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 26, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Major Depressive Disorder; Cognitive Behavior Therapy; Personal Construct Theory; Dysthymic Disorder; Repertory Grid Technique; Cognitive Conflicts; Personal dilemmas
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Dysthymic Disorder
• Other Study ID Numbers: dilemma2012; PSI2011-23246 (Other Grant/Funding Number: Ministry of Science and Innovation (Spanish Government))