Dysthymic Disorder, Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, Dysthymic Disorder, Depression, Cognitive Behavior Therapy, Personal Construct Theory, Repertory Grid Technique, Cognitive Conflicts, Personal dilemmas
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 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.
Interventions
BEHAVIORALCombined 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.
Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
Sponsors
National Distance Education University (UNED)
University of Minho
University of Hertfordshire
University of Bern
University Ramon Llull
Institut Trastorn Límit
Hospital de Mataró
Fundació Institut de Recerca de l
Associació Centre de Salut Mental Nou Barris
Fundacion IMIM
EAP Poble Sec
Associació Catalana de Terapies Cognitives
Sant Pere Claver Fundació Sanitaria
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hamilton-Depression Rating Scale-17 Items | 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 | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| 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. | 63 |
| Total | 128 |
Baseline characteristics
| Characteristic | Cognitive Behavioral + Dilemma Therapy | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| Age, Continuous | 48.37 years STANDARD_DEVIATION 11.22 | 50.06 years STANDARD_DEVIATION 11.03 | 49.20 years STANDARD_DEVIATION 11.19 |
| Sex: Female, Male Female | 51 Participants | 48 Participants | 99 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: End of therapy (16 weeks), 3 and 12-month follow-up
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | Baseline | 37.23 units on a scale | Standard Deviation 8.96 |
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | At the end of therapy change from baseline | -17.62 units on a scale | Standard Deviation 12.05 |
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | 3-month follow-up change from baseline | -15.42 units on a scale | Standard Deviation 13.16 |
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | 12-month follow-up change from baseline | -19.51 units on a scale | Standard Deviation 13.17 |
| Cognitive Behavioral Therapy | Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | 12-month follow-up change from baseline | -16.65 units on a scale | Standard Deviation 13.87 |
| Cognitive Behavioral Therapy | Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | Baseline | 36.94 units on a scale | Standard Deviation 9.56 |
| Cognitive Behavioral Therapy | Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | 3-month follow-up change from baseline | -15.60 units on a scale | Standard Deviation 15.56 |
| Cognitive Behavioral Therapy | Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up | At the end of therapy change from baseline | -15.52 units on a scale | Standard Deviation 13.92 |
p-value: 0.695% CI: [-3.35, 1.43]Mixed Models Analysis
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.
Time frame: End of therapy, 3 and 12 month follow-up
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up | Baseline | 2.17 units on a scale | Standard Deviation 0.5 |
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up | At the end of therapy change from baselina | -0.76 units on a scale | Standard Deviation 0.7 |
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up | 3 month follow-up change from baseline | -0.59 units on a scale | Standard Deviation 0.76 |
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up | 12 month follow-up change from baseline | -0.77 units on a scale | Standard Deviation 0.81 |
| Cognitive Behavioral Therapy | Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up | 12 month follow-up change from baseline | -0.58 units on a scale | Standard Deviation 0.86 |
| Cognitive Behavioral Therapy | Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up | Baseline | 2.08 units on a scale | Standard Deviation 0.56 |
| Cognitive Behavioral Therapy | Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up | 3 month follow-up change from baseline | -0.63 units on a scale | Standard Deviation 0.8 |
| Cognitive Behavioral Therapy | Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up | At the end of therapy change from baselina | -0.67 units on a scale | Standard Deviation 0.75 |
p-value: 0.8495% CI: [-0.14, 0.12]Mixed Models Analysis
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.
Time frame: End of therapy and 12-month follow-up
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Hamilton-Depression Rating Scale-17 Items | Baseline | 18.93 units on a scale | Standard Deviation 6.96 |
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Hamilton-Depression Rating Scale-17 Items | At the end of therapy change from baseline | -7.61 units on a scale | Standard Deviation 9.21 |
| Cognitive Behavioral + Dilemma Therapy | Change From Baseline in Hamilton-Depression Rating Scale-17 Items | 12 month follow-up change from baseline | -5.32 units on a scale | Standard Deviation 9.56 |
| Cognitive Behavioral Therapy | Change From Baseline in Hamilton-Depression Rating Scale-17 Items | Baseline | 20.05 units on a scale | Standard Deviation 6.09 |
| Cognitive Behavioral Therapy | Change From Baseline in Hamilton-Depression Rating Scale-17 Items | At the end of therapy change from baseline | -8.84 units on a scale | Standard Deviation 8.28 |
| Cognitive Behavioral Therapy | Change From Baseline in Hamilton-Depression Rating Scale-17 Items | 12 month follow-up change from baseline | -7.89 units on a scale | Standard Deviation 9.57 |
p-value: 0.2195% CI: [-0.71, 3.25]Mixed Models Analysis