Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Major Depressive Disorder Dysthymic Disorder |
Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy Behavioral: Cognitive Behavioral Therapy for Depression |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention |
- Change from Baseline in Beck Depression Inventory-Second Edition (BDI-II)at the end of therapy [ Time Frame: End of therapy (16 weeks) ] [ Designated as safety issue: Yes ]To assess change in severity of depressive symptoms
| Estimated Enrollment: | 112 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Marta Salla, Ph.D. Cand. | +34933125098 | martasalla84@hotmail.com |
| Contact: Olga Pucurull, Ph.D. Cand. | +34933125809 | opucurull@ub.edu |
| Spain | |
| Hospital de Mataro (Consorci Sanitari del Maresme) | Recruiting |
| Mataro, Barcelona, Spain, 08304 | |
| Contact: Josep Cañete, M.D. +3493741700 jcanete@csdm.cat | |
| Contact: Cristina Martinez-Viana, Clin Psy +3493741700 cmartinezvi@csdm.cat | |
| Principal Investigator: Josep Cañete, M.D. | |
| Sub-Investigator: Cristina Martinez-Viana, Clin Psy | |
| Principal Investigator: | Guillem Feixas, Ph.D. | University of Barcelona |
More Information
No publications provided
| Responsible Party: | Dr. Guillem Feixas, Professor, University of Barcelona |
| ClinicalTrials.gov Identifier: | NCT01542957 History of Changes |
| Other Study ID Numbers: | dilemma2012, PSI2011-23246 |
| Study First Received: | February 26, 2012 |
| Last Updated: | March 6, 2012 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by University of Barcelona:
|
Major Depressive Disorder Dysthymic Disorder Depression Cognitive Behavior Therapy |
Personal Construct Theory Repertory Grid Technique Cognitive Conflicts Personal dilemmas |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Dysthymic Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013