Depressive DisorderACT GDF-15NCT06195436
Efficacy of Acceptance and Commitment Therapy on Serum GDF-15 Levels in Older Adults With and Without Depression: a Non-randomized Intervention Study
A study testing Acceptance and Commitment Therapy for people with and without depression in people with Depressive Disorder, run by Universidad de Colima.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Acceptance and Commitment Therapy for people with and without depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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) .
Read more
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.
- Conditions
- Depressive Disorder
- Being tested
- Acceptance and Commitment Therapy for people with and without depression
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy for people with and without depressionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy for people with depression | Active comparator | Acceptance and Commitment Therapy for people with depression Receives: Behavioral: Acceptance and Commitment Therapy for people with and without depression |
| Acceptance and Commitment Therapy for people without depression. | Active comparator | Not described Receives: Behavioral: Acceptance and Commitment Therapy for people with and without depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Colima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Huerta, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195436
- Sponsor's protocol ID
- ACT_GDF15
- Acronym
- ACT GDF-15
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acceptance and Commitment Therapy on Serum GDF-15 Levels in Older Adults With and Without Depression: a Non-randomized Intervention Study
- ClinicalTrials.gov ID
- NCT06195436
- Acronym / sponsor ID
- ACT GDF-15 / ACT_GDF15
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de ColimaUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy for people with depression | Active comparator | Behavioral: Acceptance and Commitment Therapy for people with and without depressionAcceptance and Commitment Therapy for people with depression |
| Acceptance and Commitment Therapy for people without depression. | Active comparator | Behavioral: Acceptance and Commitment Therapy for people with and without depression |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy for people with and without depressionParticipants 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. | Behavioural | Acceptance and Commitment Therapy for people with depression, Acceptance and Commitment Therapy for people without depression. |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy for people with and without depression in people with Depressive Disorder, run by Universidad de Colima.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo García Rodríguez, MSc (+523121258825, ricardogarcirodri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GDF-15 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.