Condition category
Mental and Behavioural Disorders
Date applied
10/06/2013
Date assigned
20/06/2013
Last edited
23/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
Cezar Giosan
cgiosan@gmail.com

Trial website

http://www.DarwinianPsychotherapy.com

Contact information

Type

Scientific

Primary contact

Dr Cezar Giosan

ORCID ID

Contact details

33-40 88th Street
Jackson Heights
11372
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PN-II-ID PCE 2011-3-0230

Study information

Scientific title

Darwinian psychotherapy: A clinical trial for an evolutionary-driven type of intervention for depression

Acronym

Study hypothesis

This study examines the efficiency of an evolutionary-driven cognitive therapy for depression, contrasted with classical cognitive therapy for depression.

Ethics approval

Ethics Commission, Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, 05/05/2013, DCMP: 31205/24.05.2013

Study design

Uni-center randomized interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/10/2011

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

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

01/10/2011

Recruitment end date

30/09/2014

Locations

Countries of recruitment

Romania

Trial participating centre

33-40 88th Street
Jackson Heights
11372
United States of America

Sponsor information

Organisation

Romanian Authority for Scientific Research (Romania)

Sponsor details

Str. Mendeleev nr. 21-25
Sector 1
Bucharest
010362
Romania

Sponsor type

Research council

Website

http://www.cncs-nrc.ro/

Funders

Funder type

Research council

Funder name

Romanian Authority for Scientific Research: CNCS-UEFISCDI (Romania) Grant number: PN-II-ID PCE 2011-3-0230

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24641778

Publication citations

  1. Protocol

    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.

Additional files

Editorial Notes