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Clinical Trials/NCT06195436
NCT06195436Not yet recruitingNot Applicable

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

Universidad de Colima0 sites60 target enrollmentStarted: August 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
GDF-15

Study Overview

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 .

Detailed Description

Research question:

What is the efficacy of the implementation of Acceptance and Commitment Therapy in a group modality for twelve weeks on the serum levels of GDF-15 in older adults with and without depression?

General objective:

To determine the effectiveness of the implementation of Acceptance and Commitment Therapy in a group mode for twelve weeks on the serum levels of GDF-15 in older adults with and without depression .

Specific objectives:

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

Acceptance and Commitment Therapy for people with depression

Active Comparator

Acceptance and Commitment Therapy for people with depression

Intervention: Acceptance and Commitment Therapy for people with and without depression (Behavioral)

Acceptance and Commitment Therapy for people without depression.

Active Comparator

Intervention: Acceptance and Commitment Therapy for people with and without depression (Behavioral)

Outcomes

Primary Outcomes

GDF-15

Time Frame: 12 weeks

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Miguel Huerta

PhD Md

Universidad de Colima

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