Darwinian psychotherapy for depression

ISRCTN	ISRCTN64664414
DOI	https://doi.org/10.1186/ISRCTN64664414
Secondary identifying numbers	PN-II-ID PCE 2011-3-0230

Submission date: 10/06/2013
Registration date: 20/06/2013
Last edited: 16/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Dr Cezar Giosan
Scientific

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

Study information

Study design	Uni-center randomized interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Darwinian psychotherapy: A clinical trial for an evolutionary-driven type of intervention for depression
Study objectives	This study examines the efficiency of an evolutionary-driven cognitive therapy for depression, contrasted with classical cognitive therapy for depression.
Ethics approval(s)	Ethics Commission, Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, 05/05/2013, DCMP: 31205/24.05.2013
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2011
Completion date	30/09/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
Key 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
Key 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.
Date of first enrolment	01/10/2011
Date of final enrolment	30/09/2014

Locations

Countries of recruitment

Romania
United States of America

Study participating centre

33-40 88th Street

Jackson Heights
11372
United States of America

Sponsor information

Romanian Authority for Scientific Research (Romania)
Research council

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

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

Funders

Funder type

Research council

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

No information available

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	19/03/2014		Yes	No
Basic results		10/06/2020	16/06/2020	No	No

Additional files

ISRCTN64664414_BasicResults_10Jun2020.pdf: uploaded 16/06/2020

Editorial Notes

16/06/2020: The basic results of this trial have been uploaded as an additional file.
02/06/2020: The contact email address was changed.
26/02/2019: The intention to publish date has been added.