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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Major Depressive Disorder, Dysthymic Disorder

Intervention / Treatment
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* Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy
* Behavioral: Cognitive Behavioral Therapy for Depression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral + Dilemma Therapy<br>Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention | Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy<br>* 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.<br>* Other names: Personal Construct Therapy;|
| Active Comparator: Cognitive Behavioral Therapy<br>Combined Group and Individual Cognitive Behavioral Therapy | Behavioral: Cognitive Behavioral Therapy for Depression<br>* Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.<br>* Other names: Cognitive Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 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. | End of therapy (16 weeks), 3 and 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hamilton-Depression Rating Scale-17 Items | 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. | End of therapy and 12-month follow-up | 
| Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 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. | End of therapy, 3 and 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Dysthymic Disorder, Depression, Cognitive Behavior Therapy, Personal Construct Theory, Repertory Grid Technique, Cognitive Conflicts, Personal dilemmas