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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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-
Sponsor: University of Barcelona

Current Primary Outcome: Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up [ Time Frame: 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.


Original Primary Outcome: Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy [ Time Frame: End of therapy (16 weeks) ]

To assess change in severity of depressive symptoms


Current Secondary Outcome:

  • Change From Baseline in Hamilton-Depression Rating Scale-17 Items [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome:

Information By: University of Barcelona

Dates:
Date Received: February 26, 2012
Date Started: November 2011
Date Completion:
Last Updated: February 17, 2017
Last Verified: February 2017