DepressionPAT4ELANCT06273137
Positive Affect Treatment for Adolescents With Early Life Adversity
A study testing Positive affect treatment and Supportive psychotherapy (SUP) in people with Depression, run by University of California, Irvine at 1 site in United States.
Trial summary
Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Positive affect treatment and Supportive psychotherapy (SUP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2024to 31 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 12-16
- exposed to 2 or more adverse childhood experiences (ACEs)
Who cannot join
- currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies)
- current or past history of manic or psychotic symptoms
- parent-reported diagnosis of intellectual disability or autism spectrum disorder
- chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis),
- bleeding disorders such as hemophilia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Irvine
Irvine, California, 92617
Kate R Kuhlman, 9498245574, krkuhl@uci.edu
About this study
Official title: Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy
Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For the initial pilot phase of the investigation, the investigators will recruit up to 30 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. For the second phase of the investigation, the investigators will recruit up to 300 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or supportive psychotherapy. For both phases, at study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia and reward sensitivity). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.
- Conditions
- Depression
- Being tested
- Positive affect treatment, Supportive psychotherapy (SUP)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive affect treatmentBehavioural
Also called PAT
PAT includes 15 weekly, 1-hour sessions. The treatment is composed of three modules targeting behaviors (Sessions 1-7), cognitions (Sessions 8 -10), and compassion (Sessions 11-14), with skills being reinforced in a cumulative manner in subsequent sessions. The final session in the original treatment (Session 15) addressed relapse prevention, which will be adapted to focus on further reinforcing and generalizing learned skills. The treatment includes guided activities that target different aspects of positive affectivity such as reward approach-motivation, reward learning, and reward attainment.
Supportive psychotherapy (SUP)Behavioural
Supportive psychotherapy provides a time, attention, and social support control that is similar to a placebo but likely to be perceived as relevant to this population.
| Study group | Role | What they receive |
|---|---|---|
| Positive affect treatment | Experimental | PAT is a 15-week cognitive-behavioral therapy that focuses on increasing reward motivation and sensitivity at the neural, behavioral, and affective levels of analysis. These observed effects occur through PAT's effects on reward sensitivity and positive affect. Participants will be assigned to a therapist with training in cognitive-behavioral therapy who will meet with them weekly via telehealth. Receives: Behavioral: Positive affect treatment |
| Waitlist | No intervention | Not described |
| Supportive Psychotherapy (SUP) | Active comparator | Participants randomized to SUP will receive 15 weeks of SUP from a doctoral student in clinical psychology. SUP is a flexibly-delivered, manualized evidence-based treatment that focuses on reinforcing a patient's existing coping strategies while fostering a positive therapeutic relationship. Supportive psychotherapy provides a time, attention, and social support control that is similar to a placebo but likely to be perceived as relevant to this population. Receives: Behavioral: Supportive psychotherapy (SUP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms - anhedonia subscale
Reynolds Adolescent Depression Scale 2nd Edition - anhedonia subscale score; Scores can range from 7-28 with higher values indicating more severe anhedonia.
Measured: 4 months / end of treatment
reward sensitivity
Reward motivation will be assessed behaviorally with the Effort Expenditures for Reward Task (EEfRT). The EEfRT assesses reward sensitivity by compelling participants to choose to engage in high and low effort motor tasks for varying potential monetary gains and computes reward sensitivity as the difference in propensity to choose hard choice trials at increasing trial values.
Measured: 4 months / end of treatment
Systemic inflammation - C-reactive protein (CRP)
C-reactive protein concentrations measured in saliva; assay detection range is approximately 25 pg/mL - 1600 pg/mL with higher values indicating the presence of more systemic inflammation.
Measured: 4 months / end of treatment
8. Self-reported reward sensitivity
Self-reported reward sensitivity will be assessed using the 21-item Positive Valence System Scale (PVSS-21) which will be assessed at study enrollment, and then 4-, 8-, and 12-months after study enrollment. For each item, responses can range from 1-8, and the questionnaire is scored using a sum. Total scores can range from 21 - 189 and lower scores reflect a worse outcome.
Measured: 4 months / end of treatment
Secondary outcomes (1)
Inflammatory gene expression
Degree of expression of 19 pro-inflammatory genes as measured via genome-wide transcriptional profiling of RNA from peripheral blood mononuclear cells. Values are expressed as z-scores, and higher values indicate greater average expression of pro-inflammatory genes.
Measured: 4 months / end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start3 Feb 2024
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to either receive PAT or one of two control conditions (waitlist, supportive psychotherapy) upon enrollment.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Kuhlman, University of California, Irvine
- Investigators
- Kate R Kuhlman, Principal investigator, UC Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273137
- Sponsor's protocol ID
- 2963
- Acronym
- PAT4ELA
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy
- ClinicalTrials.gov ID
- NCT06273137
- Acronym / sponsor ID
- PAT4ELA / 2963
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 22 Feb 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.
Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For the initial pilot phase of the investigation, the investigators will recruit up to 30 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. For the second phase of the investigation, the investigators will recruit up to 300 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or supportive psychotherapy. For both phases, at study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia and reward sensitivity). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized to either receive PAT or one of two control conditions (waitlist, supportive psychotherapy) upon enrollment.
| Arm | Type | Receives |
|---|---|---|
| Positive affect treatment | Experimental | Behavioral: Positive affect treatmentPAT is a 15-week cognitive-behavioral therapy that focuses on increasing reward motivation and sensitivity at the neural, behavioral, and affective levels of analysis. These observed effects occur through PAT's effects on reward sensitivity and positive affect. Participants will be assigned to a therapist with training in cognitive-behavioral therapy who will meet with them weekly via telehealth. |
| Waitlist | No intervention | – |
| Supportive Psychotherapy (SUP) | Active comparator | Behavioral: Supportive psychotherapy (SUP)Participants randomized to SUP will receive 15 weeks of SUP from a doctoral student in clinical psychology. SUP is a flexibly-delivered, manualized evidence-based treatment that focuses on reinforcing a patient's existing coping strategies while fostering a positive therapeutic relationship. Supportive psychotherapy provides a time, attention, and social support control that is similar to a placebo but likely to be perceived as relevant to this population. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 12-16
- exposed to 2 or more adverse childhood experiences (ACEs)
Key exclusion criteria (5 listed)
- currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies)
- current or past history of manic or psychotic symptoms
- parent-reported diagnosis of intellectual disability or autism spectrum disorder
- chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis),
- bleeding disorders such as hemophilia
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 |
|---|---|---|
| Positive affect treatmentAlso: PATPAT includes 15 weekly, 1-hour sessions. The treatment is composed of three modules targeting behaviors (Sessions 1-7), cognitions (Sessions 8 -10), and compassion (Sessions 11-14), with skills being reinforced in a cumulative manner in subsequent sessions. The final session in the original treatment (Session 15) addressed relapse prevention, which will be adapted to focus on further reinforcing and generalizing learned skills. The treatment includes guided activities that target different aspects of positive affectivity such as reward approach-motivation, reward learning, and reward attainment. | Behavioural | Positive affect treatment |
| Supportive psychotherapy (SUP)Supportive psychotherapy provides a time, attention, and social support control that is similar to a placebo but likely to be perceived as relevant to this population. | Behavioural | Supportive Psychotherapy (SUP) |
Primary outcome
depressive symptoms - anhedonia subscale
Time frame: 4 months / end of treatment
Reynolds Adolescent Depression Scale 2nd Edition - anhedonia subscale score; Scores can range from 7-28 with higher values indicating more severe anhedonia.
reward sensitivity
Time frame: 4 months / end of treatment
Reward motivation will be assessed behaviorally with the Effort Expenditures for Reward Task (EEfRT). The EEfRT assesses reward sensitivity by compelling participants to choose to engage in high and low effort motor tasks for varying potential monetary gains and computes reward sensitivity as the difference in propensity to choose hard choice trials at increasing trial values.
Systemic inflammation - C-reactive protein (CRP)
Time frame: 4 months / end of treatment
C-reactive protein concentrations measured in saliva; assay detection range is approximately 25 pg/mL - 1600 pg/mL with higher values indicating the presence of more systemic inflammation.
8. Self-reported reward sensitivity
Time frame: 4 months / end of treatment
Self-reported reward sensitivity will be assessed using the 21-item Positive Valence System Scale (PVSS-21) which will be assessed at study enrollment, and then 4-, 8-, and 12-months after study enrollment. For each item, responses can range from 1-8, and the questionnaire is scored using a sum. Total scores can range from 21 - 189 and lower scores reflect a worse outcome.
1 secondary outcome
Inflammatory gene expression
Time frame: 4 months / end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers.
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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.
Kate R Kuhlman principal investigator
UC Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive affect treatment and Supportive psychotherapy (SUP) in people with Depression, run by University of California, Irvine at 1 site in United States.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate R Kuhlman, Ph.D. (9498245574, krkuhl@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depressive symptoms - anhedonia subscale (time frame: 4 months / end of treatment). The study lists 4 primary outcomes in all. 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 6 May 2026.