Efficacy of Acceptance and Commitment Therapy on Serum GDF-15 Levels in Older Adults With and Without Depression: a Non-randomized Intervention Study

NCT06195436 | Unknown DMC

• 1 other identifier: ACT_GDF15
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

In a world where the population is aging, strategies are required that promote physical, social and mental health in these age groups. Depression associated with biological aging is evidenced by clinical findings and biological markers in the course of the disease (such is the case of the GDF-15). The presence of mental health disorders, such as depression, favors the risk of premature mortality (even 25 years less than the general population, even controlling for the suicide variable. In addition, older adult patients with depression have a higher risk of presenting chronic diseases, immunological alterations, and neurocognitive disorders , favoring accelerated aging that contributes to a reduction in their intrinsic and functional capacities. (51) . GDF -15 has been proposed as a pro-aging protein , specifically promoted by mitochondrial dysfunction, which in turn leads to accelerated aging through oxidative stress. In addition, considering that mental health requires care through therapies with the necessary scientific evidence to have an impact on the mental and physical health of older adults, therefore , Acceptance and Commitment Therapy is proposed as a way to lead to healthy aging that promotes less oxidative stress derived from the same depression. Therefore, the purpose of this study is focused on demonstrating the efficacy of acceptance and commitment therapy implemented for twelve weeks in a group of older adults with and without depression, and evaluating it considering the serum levels of GDF- 15 .

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• GDF-15

  the serum levels resulting from the measurement with the ELISA technique with a specific Kit for GDF-15. The values will be presented through the difference before and after both study interventions in each participant (value after the intervention - value before the intervention).

  12 weeks

Study Arms (2)

Acceptance and Commitment Therapy for people with depression

ACTIVE COMPARATOR

Acceptance and Commitment Therapy for people with depression

Behavioral: Acceptance and Commitment Therapy for people with and without depression

Acceptance and Commitment Therapy for people without depression.

ACTIVE COMPARATOR

Behavioral: Acceptance and Commitment Therapy for people with and without depression

Interventions

Acceptance and Commitment Therapy for people with and without depression BEHAVIORAL

Participants with and without depression will be assigned to two study groups; both groups will undergo Acceptance and Commitment Therapy based on the required guidelines for twelve weeks.

Acceptance and Commitment Therapy for people with depression; Acceptance and Commitment Therapy for people without depression.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 60 years of age of any gender with at least nine years of studies.
• People belonging to the group of Retirees and Pensioners of the University of Colima AC
• People who wish to voluntarily participate in the study.
• People with and without depression.

You may not qualify if:

• People who are undergoing psychological treatment or who in the last 12 months have undergone some psychological therapy.
• People under drug treatment for depression.
• People with a score of less than 23 points in the assessment of the cognitive state by the Minimental .
• People with medical diagnosis of neurocognitive diseases.

Sponsors & Collaborators

• Universidad de Colima: lead

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Central Study Contacts

Ricardo García Rodríguez, MSc

CONTACT

+523121258825; ricardogarcirodri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: For ethical reasons, it is methodologically inappropriate to randomize the study groups, so the protocol will adhere to the TREND guidelines (Transparent Reports of Non-randomized Evaluations \[for its acronym in English: Transparent reporting of reviews with nonrandomized Designs \]), which share several criteria with CONSORTs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Md

Model Details: Conceptual definition: "It is framed in a functional philosophical position, it is based on a new Theory of Language and Cognition; offers an alternative to traditional psychopathology: the functional dimension of Experiential Avoidance; and promotes basic research and controlled trials". Operational definition: Participants with and without depression will be assigned to two study groups; both groups will undergo Acceptance and Commitment Therapy based on the required guidelines for twelve weeks.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 8, 2024

Record last verified: 2023-12