Group Cognitive Evolutionary Therapy for Depression

NCT06359769 | Active Not Recruiting

• 1 other identifier: GROUPCET
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety

Keywords

Evolutionary Psychology; Evolutionary Psychopathology; Group Therapy; Cognitive Behavioral Therapy; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Depressive symptomatology

  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

• Anxiety symptomatology

  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

Secondary Outcomes (5)

• Sleep quality

  up to 6 months

• Stress

  up to 6 months

• Social provisions

  up to 6 months

• Satisfaction with life

  up to 6 months

• Self-perceived mate value

  up to 6 months

Study Arms (2)

Group Cognitive Evolutionary Therapy

EXPERIMENTAL

In-person therapy groups

Behavioral: Group Cognitive Evolutionary Therapy

Waitlist

NO INTERVENTION

Waitlist. No intervention for this arm.

Interventions

Group Cognitive Evolutionary Therapy BEHAVIORAL

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.

Group Cognitive Evolutionary Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to severe depressive symptoms
• age 18 to 65

You may not qualify if:

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

Sponsors & Collaborators

• University of Bucharest: lead

Study Sites (1)

University of Bucharest

Bucharest, Bucharest, 050663, Romania

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Cezar Giosan, PhD

  University of Bucharest

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)