ClinicalTrials.gg
Not yet recruitingNCT06195436ACT GDF-15Updated Jan 8, 2024

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

An interventional study of Acceptance and Commitment Therapy for people with and without depression in Depressive Disorder, sponsored by Universidad de Colima. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-08.

Sponsored by Universidad de Colima · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
60 Years and older
Sex
All
01

Study 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 .

Read the 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:

  • To determine the severity of depressive symptoms in the elderly participants.
  • To assess the serum levels of GDF-15 in the elderly participants.
  • To compare the serum levels of GDF-15 before and after the implementation of Acceptance and Commitment Therapy for twelve weeks in older adults with and without depression.
  • To compare the depressive symptoms before and after the implementation of the Acceptance and Commitment Therapy and the control group for twelve weeks.
  • Evaluate the adherence to the interventions carried out on the study participants.
  • To establish the influence of age, sex, comorbidities and socioeconomic level on the efficacy of acceptance and commitment therapy and the control group in the participants.

Study hypothesis:

Older adults with depression show a greater decrease in serum GDF-15 levels after the implementation of Acceptance and Commitment Therapy in a group mode when compared to the group without depression for twelve weeks.

Type of research and variables:

Study Design: Non-randomized intervention study.

  • 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.
02

Conditions studied

  • Depressive Disorder

Browse trials for

03

In context

Depressive Disorder

855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.

This study's planned enrollment of 60 is below the median of 88 across 689 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Universidad de Colima is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Acceptance and Commitment Therapy for people with depression

    Acceptance and Commitment Therapy for people with depression

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

  • Active comparator
    Acceptance and Commitment Therapy for people without depression.

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

Interventions

  • BehavioralAcceptance and Commitment Therapy for people with and without depression

    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.

06

What researchers measure

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).

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2024; primary completion for Jan 2025, 5 months later.

Of 260 non-industry interventional studies with no phase under Depressive Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 46. This study's planned 5 months is below that.

Counting every sponsor, half of 274 studies reached it within 29 months; a quarter within 15 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2023
First posted
Jan 8, 2024
StartEst.
Aug 1, 2024
Primary completionEst.
Jan 1, 2025
CompletionEst.
Jan 1, 2026
Last update
Jan 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06195436
Lead sponsor
Universidad de Colima
Responsible party
Miguel Huerta (PhD Md, Universidad de Colima) — Principal investigator
First posted
Jan 8, 2024
Start date
Aug 1, 2024 (estimated)
Primary completion
Jan 1, 2025 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Jan 8, 2024

Study contacts

Ricardo García Rodríguez, MSc
Contact
ricardogarcirodri@gmail.com
+523121258825

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion