Group Cognitive Evolutionary Therapy for Depression (GRCET)

March 4, 2026 updated by: Cezar Giosan, University of Bucharest

Group Cognitive Evolutionary Therapy for Depression - A Randomized Clinical Trial

The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health, especially on depressive symptoms and anxiety.

Participants will be allocated in one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist. The intervention will consist of two 8-hour sessions of Group Cognitive Therapy, in two consecutive days.

The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the study is to assess the efficacy of Group Cognitive Evolutionary Therapy on depressive symptoms and other indicators of mental health for people with mild to severe depressive symptoms. This clinical trial will provide essential insights into the potential benefits of this form of therapy. The results will contribute to the development of a short, economical and effective method of enhancing mental health for patients with mild to severe depressive symptoms.

After recruitment, participants will be randomly assigned to one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist.

The intervention group will participate in two 8-hour sessions of Cognitive Evolutionary Therapy over two consecutive days, in groups of no less than 5 and no larger than 8 people. These groups will be led by licensed psychologists with extensive knowledge of evolutionary psychology and cognitive evolutionary therapies.

Both groups will be evaluated at (1) pre-intervention (baseline), (2) one week after the intervention, and (3) three months after the intervention.

G*Power analysis yields a total of N = 44 (f = 0.25, power = 0.95) for the two conditions.

The statistical analysis plan includes the analysis of primary and secondary outcomes, which will be assessed using predefined measures described at the measures section. Additionally, the investigators will assess various predictors to gain insights into the factors influencing intervention outcomes. These predictors will be measured using specific instruments, including screeners (Diagnostic and Statistical Manual, Fifth Edition - Text Revision Self-Rated Level 1 Cross-Cutting Symptom Measure-adult version and The Personality Inventory for Diagnostic and Statistical Manual, Fifth Edition-Brief Form-adult version), and the Adverse Childhood Experiences questionnaire to assess adverse childhood experiences.

Besides demographic assessors and the above mentioned instruments, The Evolutionary Fitness Scale will be used both to determine predictors for the intervention outcome and as an assessment tool for the topics of interventions for each subject, this being a central part of Cognitive Evolutionary Therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Romania
    • Bucharest
      • Bucharest, Bucharest, Romania, 050663
        • University of Bucharest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • mild to severe depressive symptoms
  • age 18 to 65

Exclusion Criteria:

  • severe personality traits (antagonism, impulsivity, disinhibition, psychoticism)
  • formally diagnosed with a severe mental disorder
  • currently participating in any ongoing therapeutic intervention for mental health.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group Cognitive Evolutionary Therapy
In-person therapy groups
Behavioral: Group Cognitive Evolutionary Therapy
In-person therapy group. Delivery method: in-person groups. Number of sessions: 2. Duration of each session: 8 hours. Topics to be covered in the sessions are informed by the answers to the Fitness Evaluation Scale, following an adapted protocol of Cognitive Therapy for Depression.
No Intervention: Waitlist
Waitlist. No intervention for this arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety symptomatology
Time Frame: up to 6 months

Anxiety symptomatology will be assessed with the Depression Anxiety and Stress Scale (DASS 21), a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress.

The anxiety scale is a 7-question self-reported instrument designed to assess autonomic arousal, skeletal muscle effects, situation, anxiety, and subjective experience of anxious affect. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 1-week timeframe (0 - not at all; 3 - most of the time). The total score for the seven items ranges from 0 to 21 and is a dimensional value.
up to 6 months
Depressive symptomatology
Time Frame: up to 6 months
Depressive symptomatology will be assessed with the 21-item Depression Anxiety and Stress Scale (DASS 21). Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 1-week timeframe (0- not at all; 3 - nearly every day). The depression subscale is a 7-question self-reported instrument that assesses dysphoria, hopelessness, devaluation of life, self-depreciation, lack of interest, anhedonia and inertia. Clinical cutoffs are provided.
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: up to 6 months
Sleep quality will be assessed with a single item Sleep Quality Scale (SQS). Participants rate their overall sleep quality for the majority of nights in the past seven days on scale from 0 to 10, (0 - terrible, 10 - excellent)
up to 6 months
Social provisions
Time Frame: up to 6 months
Social provisions will be assessed with the 10-item Social Provisions Scale (SPS 10). Each of the 10 questions will be answered on a scale from 1 to 4 (1- strongly disagree, 4 - strongly agree) with reference to the current relationship with friends, family members, coworkers, community members and others.
up to 6 months
Satisfaction with life
Time Frame: up to 6 months
Satisfaction with life will be measured with the Satisfaction With Life Scale (SWLS). The scale consists of 5 items designed to measure global cognitive judgments of one's life satisfaction. Participants indicate how much they agree, or disagree with each of these 5 items using a 7-point scale that ranges from 1 (strongly disagree) to 7 (strongly disagree).
up to 6 months
Self-perceived mate value
Time Frame: up to 6 months
Each subject's self perceived mate value will be measured with the Components of Mate Value Survey (CMVS). The survey consists of 22 questions with reference to various dimensions of self perceived mate value, and can be answered on a scale from 1 to 5 (1 - strongly disagree, 5 - strongly agree).
up to 6 months
Stress
Time Frame: up to 6 months
By employing the Depression Anxiety and Stress Scale (DASS 21) stress will be measured by the stress subscale, sensitive to chronic non-specific arousal. The stress subscale measures difficulty relaxing, nervous arousal and being easily upset, agitation, irritability, over-reactivity, and impatience.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bucharest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Cezar Giosan, PhD, University of Bucharest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Giosan, C. (2020). Cognitive Evolutionary Therapy for Depression. Springer International Publishing. https://doi.org/10.1007/978-3-030-38874-4.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GROUPCET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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