Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
|ClinicalTrials.gov Identifier: NCT01542957|
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : December 19, 2016
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Dysthymic Disorder||Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy Behavioral: Cognitive Behavioral Therapy for Depression||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||May 2015|
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 Name: 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 Name: Cognitive Therapy
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542957
|Hospital de Mataro (Consorci Sanitari del Maresme)|
|Mataro, Barcelona, Spain, 08304|
|CAP Les Hortes|
|Barcelona, Catalonia, Spain, 08004|
|Fundació Sanitària Sant Pere Claver|
|Barcelona, Catalonia, Spain, 08004|
|Associació Catalana de Teràpies Cognitives|
|Barcelona, Catalonia, Spain, 08032|
|Principal Investigator:||Guillem Feixas, Ph.D.||University of Barcelona|