Plain English Summary
Background and study aims
Depression affects almost 7% of the population and is the most important cause of disease burden in middle- and high-income countries. Psychotherapists normally focus on events within the lifespan of a patient and examine the immediate causes of depression. Recent advances in Evolutionary Psychology, however, propose that low mood has an adaptive function. Therefore the aim of this study is to test whether interventions on the evolutionary causes of depression are beneficial for patients.
Who can participate?
Romanian-speaking adults diagnosed with increased levels of depressive symptoms are eligible to participate in this project.
What does the study involve?
The participants are randomly allocated to receive either cognitive therapy or evolutionary-driven cognitive therapy for depression. Each group undergoes 12 free one-hour therapy sessions, one session per week. The participants are evaluated psychologically at the beginning, during and at the end of treatment.
What are the possible benefits and risks of participating?
Cognitive behavioural therapy does not present known risks for the patients, most of whom will benefit from it , at least to some degree.
Where is the study run from?
This project is run from the Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University (Romania).
When is the study starting and how long is it expected to run for?
The duration of the study is three years (November 2011 November 2014).
Who is funding the study?
The study is funded by the Romanian Authority for Scientific Research (Romania).
Who is the main contact?
PN-II-ID PCE 2011-3-0230
Darwinian psychotherapy: A clinical trial for an evolutionary-driven type of intervention for depression
This study examines the efficiency of an evolutionary-driven cognitive therapy for depression, contrasted with classical cognitive therapy for depression.
Ethics Commission, Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, 05/05/2013, DCMP: 31205/24.05.2013
Uni-center randomized interventional study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Experimental group: Evolutionary-driven cognitive therapy for depression (EB-CBT). This group receives 12 EB-CBT therapy sessions, one session per week.
Control group: Cognitive therapy for depression (CBT). This group receives 12 CBT therapy sessions, one session per week.
Primary outcome measure
1. Depressive symptomatology measured with the Beck Depression Inventory (BDI)
2. Depression diagnosis, assessed by the Structured Clinical Interview for DSM-IV (SCID).
Both primary outcomes measured at baseline, fourth, eight, 12th session, and three months after the completion of the treatment.
Secondary outcome measures
1. Perceptions about quality of life
2. Social and occupational functioning
Both secondary outcomes measured at baseline, fourth, eight, 12th session, and three months after the completion of the treatment.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Romanian-speaking adults, either sex (18 years old and up) with elevated Beck Depression Inventory scores (>13)
2. Current diagnosis of Major Depressive Disorder or Episode with or without co morbid dysthymia
Target number of participants
Participant exclusion criteria
Participants presenting panic disorder, substance abuse, psychotic symptoms, organic brain disorders (e.g., dementia), imminent risk of suicide, self-injury or harming others, serious legal or health issues that would prevent from regularly attending are excluded.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
33-40 88th Street
United States of America
Romanian Authority for Scientific Research (Romania)
Str. Mendeleev nr. 21-25
Romanian Authority for Scientific Research: CNCS-UEFISCDI (Romania) Grant number: PN-II-ID PCE 2011-3-0230
Funding Body Type
Funding Body Subtype
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)
See additional files
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24641778
Giosan C, Cobeanu O, Mogoase C, Muresan V, Malta LS, Wyka K, Szentagotai A, Evolutionary cognitive therapy versus standard cognitive therapy for depression: a protocol for a blinded, randomized, superiority clinical trial., Trials, 2014, 15, 83, doi: 10.1186/1745-6215-15-83.
- ISRCTN64664414_BasicResults_10Jun2020.pdf uploaded 16/06/2020