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

Not Applicable

Completed

Conditions: Major Depressive Disorder
Dysthymic Disorder

Interventions: Behavioral: Cognitive Behavioral Therapy for Depression
Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy

Registration Number: NCT01542957

Lead Sponsor: University of Barcelona

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy for Depression	Combined Group and Individual Cognitive Behavioral Therapy
Cognitive Behavioral + Dilemma Therapy	Combined Cognitive Behavioral and Dilemma-Focused Therapy	Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up	End of therapy (16 weeks), 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Hamilton-Depression Rating Scale-17 Items	End of therapy and 12-month follow-up	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.
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	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.

Trial Locations

Locations (4): CAP Les Hortes
🇪🇸
Barcelona, Catalonia, Spain
Fundació Sanitària Sant Pere Claver
🇪🇸
Barcelona, Catalonia, Spain
Associació Catalana de Teràpies Cognitives
🇪🇸
Barcelona, Catalonia, Spain
Hospital de Mataro (Consorci Sanitari del Maresme)
🇪🇸
Mataro, Barcelona, Spain