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| ID | Type | Description | Link |
|---|---|---|---|
| PSI2011-23246 | Other Grant/Funding Number | Ministry of Science and Innovation (Spanish Government) |
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| Name | Class |
|---|---|
| National Distance Education University (UNED) | UNKNOWN |
| University of Minho | OTHER |
| University of Hertfordshire | OTHER |
| University of Bern |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral + Dilemma Therapy | Experimental | Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention |
|
| Cognitive Behavioral Therapy | Active Comparator | Combined Group and Individual Cognitive Behavioral Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Cognitive Behavioral and Dilemma-Focused Therapy | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillem Feixas, Ph.D. | University of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Mataro (Consorci Sanitari del Maresme) | Mataró | Barcelona | 08304 | Spain | ||
| CAP Les Hortes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23683841 | Background | Feixas G, Bados A, Garcia-Grau E, Montesano A, Dada G, Compan V, Aguilera M, Salla M, Soldevilla JM, Trujillo A, Paz C, Botella L, Corbella S, Saul-Gutierrez LA, Canete J, Gasol M, Ibarra M, Medeiros-Ferreira L, Soriano J, Ribeiro E, Caspar F, Winter D. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial. Trials. 2013 May 17;14:144. doi: 10.1186/1745-6215-14-144. | |
| 27103215 |
| Label | URL |
|---|---|
| Web page in Spanish and Catalan describing the research project and recruitment information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral + Dilemma Therapy | Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| End of Therapy |
|
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| OTHER |
| University Ramon Llull | OTHER |
| Institut Trastorn Límit | UNKNOWN |
| Hospital de Mataró | OTHER |
| Fundació Institut de Recerca de l | UNKNOWN |
| Associació Centre de Salut Mental Nou Barris | UNKNOWN |
| Fundacion IMIM | OTHER |
| EAP Poble Sec | UNKNOWN |
| Associació Catalana de Terapies Cognitives | UNKNOWN |
| Sant Pere Claver Fundació Sanitaria | UNKNOWN |
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|
| Cognitive Behavioral Therapy for Depression | Behavioral | Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized. |
|
|
| 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 |
| Barcelona |
| Catalonia |
| 08004 |
| Spain |
| Fundació Sanitària Sant Pere Claver | Barcelona | Catalonia | 08004 | Spain |
| Associació Catalana de Teràpies Cognitives | Barcelona | Catalonia | 08032 | Spain |
| Result |
| Feixas G, Bados A, Garcia-Grau E, Paz C, Montesano A, Compan V, Salla M, Aguilera M, Trujillo A, Canete J, Medeiros-Ferreira L, Soriano J, Ibarra M, Medina JC, Ortiz E, Lana F. A DILEMMA-FOCUSED INTERVENTION FOR DEPRESSION: A MULTICENTER, RANDOMIZED CONTROLLED TRIAL WITH A 3-MONTH FOLLOW-UP. Depress Anxiety. 2016 Sep;33(9):862-9. doi: 10.1002/da.22510. Epub 2016 Apr 22. |
| 30543642 | Derived | Feixas G, Paz C, Garcia-Grau E, Montesano A, Medina JC, Bados A, Trujillo A, Ortiz E, Compan V, Salla M, Aguilera M, Guasch V, Codina J, Winter DA. One-year follow-up of a randomized trial with a dilemma-focused intervention for depression: Exploring an alternative to problem-oriented strategies. PLoS One. 2018 Dec 13;13(12):e0208245. doi: 10.1371/journal.pone.0208245. eCollection 2018. |
| FG001 |
| Cognitive Behavioral Therapy |
Combined Group and Individual Cognitive Behavioral Therapy 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. |
| COMPLETED |
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| NOT COMPLETED |
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| 3-month Follow-up |
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| 12-month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral + Dilemma Therapy | Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention 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. |
| BG001 | Cognitive Behavioral Therapy | Combined Group and Individual Cognitive Behavioral Therapy 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified | Posted | Mean | Standard Deviation | units on a scale | End of therapy (16 weeks), 3 and 12-month follow-up |
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| Secondary | 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. | The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified. | Posted | Mean | Standard Deviation | units on a scale | End of therapy and 12-month follow-up |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified | Posted | Mean | Standard Deviation | units on a scale | End of therapy, 3 and 12 month follow-up |
|
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"0" means that serious and other [non-serious] adverse events were not collected or assessed as part of the study since no detrimental effects were expected as result of psychotherapies.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral + Dilemma Therapy | Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention 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. | 0 | 0 | 0 | 0 | ||
| EG001 | Cognitive Behavioral Therapy | Combined Group and Individual Cognitive Behavioral Therapy 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. | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Guillem Feixas | Universitat de Barcelona | 0034 933125100 | gfeixas@ub.edu |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Male |
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| At the end of therapy change from baseline |
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| 3-month follow-up change from baseline |
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| 12-month follow-up change from baseline |
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