Group Cognitive Evolutionary Therapy for Depression

Depression Clinical Trial

— GRCET  

Official title:

Group Cognitive Evolutionary Therapy for Depression - A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06359769
• Other study ID #: GROUPCET
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: University of Bucharest
• Contact: Cezar Giosan, PhD
• Phone: +40730908050
• Email: giosan[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 moderate 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 moderate 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) two weeks after the intervention, (3) three months after the intervention and (4) six months after the intervention. G*Power analysis yields a total of N = 36 (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, we will assess various predictors to gain insights into the factors influencing intervention outcomes. These predictors will be measured using specific instruments, including screeners (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure-adult version and The Personality Inventory for DSM-5-Brief Form (PID-5-BF)-adult version), and the ACE's questionnaire to assess adverse childhood experiences. Besides demographic assessors and the above mentioned instruments, The Fitness Evolutionary Scale (FES) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• moderate depression
• age 18 to 65

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder

Intervention

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 (Giosan, 2020).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bucharest

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptomatology	Depressive symptomatology will be assessed with the Patient Health Questionnaire-Severity Measure for Depression, 9 item questionnaire. Participants assign ratings on a scale of 0 to 3 based on how often they experienced specific items in the preceding 2-week timeframe (0- not at all; 3 - nearly every day). The scores indicate the severity of depression, ranging from minimal depression (1-4) to mild, moderate, moderately severe, or severe depression (20-27).	up to 6 months
Primary	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	Sleep quality	Sleep quality will be assessed with a single items 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
Secondary	Perceived stress	Perceived stress will be measured with the Perceived Stress Scale 4 - PSS 4. The total score is determined by adding together the scores of each of the four items of the scale (from 0 to 4, with questions 2 and 3 being reverse coded). The questions ask about feelings and thoughts during the last month.	up to 6 months
Secondary	Social provisions	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
Secondary	Satisfaction with life	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
Secondary	Self-perceived mate value	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