Major Depressive DisorderNCT01542957
Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
A study testing Combined Cognitive Behavioral and Dilemma-Focused Therapy and Cognitive Behavioral Therapy for Depression in people with Major Depressive Disorder and Dysthymic Disorder, run by University of Barcelona at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Dysthymic Disorder
- What is being tested?
- Combined Cognitive Behavioral and Dilemma-Focused Therapy and Cognitive Behavioral Therapy for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesSpain
- Study dates
- Nov 2011to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
CAP Les Hortes
Barcelona, Catalonia, 08004
Fundació Sanitària Sant Pere Claver
Barcelona, Catalonia, 08004
Associació Catalana de Teràpies Cognitives
Barcelona, Catalonia, 08032
Hospital de Mataro (Consorci Sanitari del Maresme)
Mataró, Barcelona, 08304
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Dysthymic Disorder
- Being tested
- Combined Cognitive Behavioral and Dilemma-Focused Therapy, Cognitive Behavioral Therapy for Depression
- Keywords
- Major Depressive Disorder, Dysthymic Disorder, Depression, Cognitive Behavior Therapy, Personal Construct Theory, Repertory Grid Technique, Cognitive Conflicts, Personal dilemmas
- Medical subject headings
- Depressive Disorder, Major, Dysthymic Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Cognitive Behavioral and Dilemma-Focused TherapyBehavioural
Also called Personal Construct 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 DepressionBehavioural
Also called Cognitive Therapy
Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral + Dilemma Therapy | Experimental | Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention Receives: Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy |
| Cognitive Behavioral Therapy | Active comparator | Combined Group and Individual Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy for Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of therapy (16 weeks), 3 and 12-month follow-up
Secondary outcomes (2)
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.
Measured: 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.
Measured: End of therapy, 3 and 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Dr. Guillem Feixas, University of Barcelona
- Investigators
- Guillem Feixas, Ph.D., Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542957
- Sponsor's protocol ID
- dilemma2012
- Other IDs
- PSI2011-23246
- Status last verified
- Feb 2017
- First submitted
- 26 Feb 2012
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23683841Feixas 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.
PubMed 27103215Feixas 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.
PubMed 30543642
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
- ClinicalTrials.gov ID
- NCT01542957
- Acronym / sponsor ID
- dilemma2012
- Conditions
- Major Depressive Disorder, Dysthymic Disorder
- Keywords
- Major Depressive Disorder, Dysthymic Disorder, Depression, Cognitive Behavior Therapy, Personal Construct Theory, Repertory Grid Technique, Cognitive Conflicts, Personal dilemmas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- 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
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Posted 19 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral + Dilemma Therapy | Experimental | Behavioral: Combined Cognitive Behavioral and Dilemma-Focused TherapyCombines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral Therapy for DepressionCombined Group and Individual Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Bipolar disorders
- Psychotic symptoms
- Substance abuse
- Organic brain dysfunction
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Cognitive Behavioral and Dilemma-Focused TherapyAlso: Personal Construct Therapy7 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. | Behavioural | Cognitive Behavioral + Dilemma Therapy |
| Cognitive Behavioral Therapy for DepressionAlso: Cognitive TherapyCognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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.
2 secondary outcomes
Change From Baseline in Hamilton-Depression Rating Scale-17 Items
Time frame: 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
Time frame: End of therapy, 3 and 12 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23683841Feixas 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.
- Results publication: PubMed 27103215Feixas 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.
- Derived from this study: PubMed 30543642Feixas 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.
- Web page in Spanish and Catalan describing the research project and recruitment informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillem Feixas, Ph.D. principal investigator
University of Barcelona
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Cognitive Behavioral and Dilemma-Focused Therapy and Cognitive Behavioral Therapy for Depression in people with Major Depressive Disorder and Dysthymic Disorder, run by University of Barcelona at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01542957, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.