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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542957
• Other study ID #: dilemma2012
• Secondary ID: PSI2011-23246
• Status: Completed
• Phase: N/A
• First received: February 26, 2012
• Last updated: June 1, 2015
• Start date: November 2011
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Dysthymic Disorder
• Major Depressive Disorder

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.
• 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.

Locations

Country	Name	City	State
Spain	Associació Catalana de Teràpies Cognitives	Barcelona	Catalonia
Spain	CAP Les Hortes	Barcelona	Catalonia
Spain	Fundació Sanitària Sant Pere Claver	Barcelona	Catalonia
Spain	Hospital de Mataro (Consorci Sanitari del Maresme)	Mataro	Barcelona

Sponsors (14)

Lead Sponsor	Collaborator
University of Barcelona	Associació Catalana de Terapies Cognitives, Associació Centre de Salut Mental Nou Barris, EAP Poble Sec, Fundació Institut de Recerca de l, Fundacion IMIM, Hospital de Mataró, Institut Trastorn Límit, National Distance Education University (UNED), Sant Pere Claver Fundació Sanitaria, University of Bern, University of Hertfordshire, University of Minho, University Ramon Llull

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Feixas G, Bados A, García-Grau E, Montesano A, Dada G, Compañ V, Aguilera M, Salla M, Soldevilla JM, Trujillo A, Paz C, Botella L, Corbella S, Saúl-Gutiérrez LA, Cañete 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the end of therapy	To assess change in severity of depressive symptoms	End of therapy (16 weeks)	Yes
Secondary	Change from baseline in Hamilton-Depression Rating Scale-17 items		End of therapy	Yes

External Links

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