Plain English Summary
Background and study aims
Depression is one of the most common mental disorders worldwide. The symptoms of depression can vary greatly from person to person, but generally include low mood, problems with sleeping and/or eating, and loss of interest in life. Depression comes in many forms, and two of the most recognised are major depressive disorder (MDD), and dysthymic disorder (DD). MMD is diagnosed when symptoms begin suddenly, last for at least two weeks and are serious enough to affect day to day life. The symptoms of DD are not quite as severe as in MDD, but last for at least two years. Although a good deal of progress has been made, the success in the treatment of these disorders is limited, as patients have a tendency to relapse. One of the reasons for this is thought to be that people suffering from these disorders have an internal struggle going on, which creates suffering and blocks their personal development (cognitive conflict). The aim of this study is to find out whether having individual dilemma-focused therapy (DFT) in combination with cognitive behavioural therapy (CBT) will be more effective than CBT alone in treating patients suffering from MDD and DD.
Who can participate?
Adults suffering from moderate to severe MDD or DD who have at least one cognitive conflict.
What does the study involve?
At the start of the study, the participants undergo a psychological assessment, in order to establish a definitive diagnosis. All participants are then given eight weekly 2 hour sessions of group CBT. They are randomly allocated into two groups. One group are given 8 individual CBT weekly sessions. The second group are given 8 individual DFT weekly sessions. After the participants have finished the course of individual therapy, they are assessed again in order to see if there is any change to their condition. This assessment is repeated twice more after three months and then after one year.
What are the possible benefits and risks of participating?
A potential benefit of participating is that participants will have access to therapies which are not usually offered, which may help their conditions. There are no notable risks of taking part in the trial.
Where is the study run from?
Universitat de Barcelona (Spain)
When is study starting and how long is it expected to run for?
November 2011 to June 2014
Who is funding the study?
Ministry of Economy, Secretary of Research, Development and Innovation (Spain)
Who is the main contact?
Dr Guillem Feixas
gfeixas@ub.edu
Trial website
Contact information
Type
Scientific
Primary contact
Prof Guillem Feixas
ORCID ID
Contact details
Universitat de Barcelona
Campus Mundet - Psicologia
Edifici Ponent
despatx 3601
Passeig Vall d'Hebron
171
Barcelona
08035
Spain
+34933125100
gfeixas@ub.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01542957
Protocol/serial number
PSI2011-23246
Study information
Scientific title
Cognitive therapy for unipolar Depression: efficacy of a dilemma-focused intervention, a randomised controlled trial
Acronym
CTFORDEP
Study hypothesis
A new brief intervention focused on the dilemma(s) specifically detected for each patient in addition to CBT will be more efficacious than CBT alone. Patients diagnosed with Major Depressive Disorder and those with Dysthymic Disorcer allocated in the combined dilemma-focused and CBT will show higher reductions in depressive symptoms and more general improvement in functioning and wellbeing.
Ethics approval
University of Barcelona Ethics Committee, 04 July 2011, ref: IRB00003099
Hospital of Mataró Ethics Committee 21 December 2011
Study design
Randomised single-blind treatment efficacy study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Major Depressive Disorder, dysthymic disorder.
Intervention
Combined Group Cognitive Behavioral (8, 2-hour weekly sessions) and Individual Dilemma-Focused Therapy (8, 1-hour weekly sessions)
Cognitive Behavioral Therapy (8, 2-hour group weekly sessions and 8, 1-hour individual weekly sessions)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Change from baseline in Beck Depression Inventory-Second Edition (BDI-II) at the end of therapy.
Secondary outcome measures
1. Change from baseline in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) at the end of therapy
2. Change from baseline in Hamilton Anxiety Rating Scale (HARS) at the end of therapy
3. Change from baseline in measures of the Repertory Grid Technique
Overall trial start date
20/11/2011
Overall trial end date
30/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 to 70 years old
2. Both genders
3. Meeting diagnostic criteria for Major Depressive Disorder (MDD) or Dysthymic Disorder (DD) according to the DSM-IV-TR (APA, 2002) criteria assessed using SCID-I
4. A score above 19 on the BDI-II Questionnaire
5. Presenting at least one cognitive conflict (implicative dilemma or dilemmatic construct) as assessed using the Repertory Grid Technique
6. Enough level of competence to communicate in Spanish or Catalan
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
112 patients. To achieve minimal requirements of statistical analysis, some additional recruiting will be needed if too few men or dysthymic patients are included for the study.
Total final enrolment
128
Participant exclusion criteria
1. Bipolar disorders
2. Psychotic symptoms
3. Substance abuse
4. Organic brain dysfunction
5. Mental retardation
6. Serious suicidal ideation
7. 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)
8. Substantial visual, hearing or cognitive deficits
Recruitment start date
20/11/2011
Recruitment end date
30/06/2014
Locations
Countries of recruitment
Spain
Trial participating centre
Universitat de Barcelona
Barcelona
08035
Spain
Sponsor information
Organisation
University of Barcelona (Spain)
Sponsor details
Department of Personality
Assessment and Psychological Treatment
Faculty of Psychology
Campus Mundet (UB)
Passeig Vall d'Hebron
171
Facultat de Psicologia
Barcelona
08035
Spain
+34933125100
gfeixas@ub.edu
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Ministry of Economy, Secretary of Research, Development and Innovation (Spain) ref: PSI2011-23246
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23683841 (added 25/10/2013)
2. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27103215 (added 16/04/2019)
3. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/26367519 (added 16/04/2019)
4. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30543642 (added 16/04/2019)
Publication citations
-
Protocol
Feixas G, Bados A, García-Grau E, Montesano A, Dada G, Compañ V, Aguilera M, Salla M, Soldevilla JM, Trujillo A, Paz C, Botella L, Corbella S, Saúl-Gutiérrez LA, Cañete 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, 14, 144, doi: 10.1186/1745-6215-14-144.