Positive Affect Treatment for Depression

(PAT4ELA Trial)

Overseen By Kate R Kuhlman, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Antidepressants, Steroids

Disqualifiers: Manic, Psychotic, Autism, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 15 weeks

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether Positive Affect Training (PAT) can help adolescents who have faced early life adversities feel more positive emotions and reduce their risk of depression. The study involves 22 adolescents and measures their mood over several months to see if PAT is effective.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking an antidepressant or any medications that affect immune functioning daily, like certain asthma or allergy medications.

What data supports the effectiveness of the Positive Affect Treatment (PAT) for depression?

Research on similar treatments, like Positive Psychotherapy and Positive Cognitive Behavior Therapy, shows that focusing on increasing positive emotions can significantly reduce depressive symptoms and improve overall well-being. These treatments have been found to be effective in both group and individual settings, suggesting that PAT may also help people with depression by enhancing positive feelings. ^{1 2 3 4 5}

Is Positive Affect Treatment (PAT) safe for humans?

The research articles do not provide specific safety data for Positive Affect Treatment (PAT), but they suggest that treatments focusing on increasing positive emotions, like PAT, are generally well-received and can be beneficial for mood improvement without mentioning any safety concerns. ^{2 3 4 6 7}

How is Positive Affect Treatment (PAT) different from other treatments for depression?

Positive Affect Treatment (PAT) is unique because it focuses on increasing positive emotions and well-being, rather than just reducing negative symptoms. This approach targets core symptoms like anhedonia (inability to feel pleasure), which may respond better to interventions aimed at enhancing positivity. ^{1 2 6 7 8}

Research Team

Kate R Kuhlman

Principal Investigator

UC Irvine

Eligibility Criteria

This trial is for adolescents who have faced two or more types of childhood adversity but do not currently suffer from major depressive disorder. It aims to help those at risk for depression due to early life challenges.

Inclusion Criteria

I am between 12 and 16 years old.

Exposed to 2 or more adverse childhood experiences (ACEs)

Exclusion Criteria

Parent-reported diagnosis of intellectual disability or autism spectrum disorder

I have experienced manic or psychotic symptoms in the past or currently.

I have a long-term health condition like cancer or diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Positive Affect Therapy (PAT) for 15 weeks, focusing on increasing reward motivation and sensitivity

15 weeks

15 visits (virtual)

Follow-up

Participants are monitored for positive affect and depressive symptoms at 4, 8, and 12 months

12 months

3 visits (virtual)

Treatment Details

Interventions

• Positive Affect Treatment

Trial Overview The study tests Positive Affect Treatment (PAT) on these youths, comparing a group receiving PAT with a waitlist control group. The goal is to see if PAT can boost positive feelings and reduce symptoms of depression over time.

Participant Groups

Group I: Positive affect treatment Experimental Treatment 1 Intervention

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.

Group II: Supportive Psychotherapy (SUP) Active Control 1 Intervention

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.

Group III: Waitlist Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

The Clinical Positive Affect Scale (CPAS) was developed and validated as a 16-item self-report tool to measure self-perceived positive affect in a sample of 300 college students, demonstrating high internal consistency (α = 0.97).

The CPAS effectively captures positive affect and shows good validity, as it correlates negatively with measures of depression, anxiety, and drug abuse, indicating its potential usefulness for clinicians and researchers in assessing patients' emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The absence of depressive symptoms is not the presence of wellness: validation of the Clinical Positive Affect Scale. Nierenberg, AA., Bentley, KH., Farabaugh, AH., et al.[2019]

The Positive Affect Stimulation and Sustainment (PASS) Module showed a moderate effect in reducing depressive symptoms among 27 female college students with dysphoric symptoms, indicating its potential as a treatment approach.

Participants in the PASS group experienced a significant increase in positive affect after sessions, while the control group showed a decrease, suggesting that PASS effectively enhances positive emotional states during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Affect Stimulation and Sustainment (PASS) Module for Depressed Mood: A preliminary investigation of treatment-related effects. McMakin, DL., Siegle, GJ., Shirk, SR.[2021]

A pilot study involving 29 individuals with anxiety and depression showed that a 10-session positive activity intervention (PAI) significantly improved positive affect and psychological well-being compared to a waitlist group.

The PAI not only enhanced positive emotions but also led to substantial reductions in negative affect and symptoms of anxiety and depression, with these improvements lasting for at least 6 months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upregulating the positive affect system in anxiety and depression: Outcomes of a positive activity intervention. Taylor, CT., Lyubomirsky, S., Stein, MB.[2020]

Positive psychotherapy (PPT) focuses on enhancing positive emotions and engagement rather than just reducing depressive symptoms, showing significant long-term benefits, including a decrease in mild-to-moderate depression levels for up to a year in group settings.

In individual treatments for major depressive disorder, PPT resulted in higher remission rates compared to standard treatments and those combined with medication, suggesting it can be an effective supplement to traditional depression therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive psychotherapy. Seligman, MEP., Rashid, T., Parks, AC.[2022]

In a study involving 49 patients with major depressive disorder, positive Cognitive Behavior Therapy (P-CBT) led to significantly greater improvements in depressive symptoms compared to traditional CBT (T-CBT) during the second treatment block, indicating its enhanced efficacy.

P-CBT not only improved depressive symptoms but also resulted in higher rates of clinically significant changes in negative affect and happiness, with effect sizes indicating a strong positive impact on overall mental health, bringing participants' positive emotions to normative levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive cognitive behavior therapy in the treatment of depression: A randomized order within-subject comparison with traditional cognitive behavior therapy. Geschwind, N., Arntz, A., Bannink, F., et al.[2020]

Greater moment-to-moment persistence of positive affect (PA) in daily life is linked to a lower likelihood of depressive symptoms in the future, as shown in a study with 540 participants from the general population.

Patients with recurrent depression who exhibit higher PA persistence are more likely to respond positively to treatment, especially when receiving antidepressants like imipramine, indicating that enhancing PA may be crucial for effective depression recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moment-to-moment transfer of positive emotions in daily life predicts future course of depression in both general population and patient samples. Höhn, P., Menne-Lothmann, C., Peeters, F., et al.[2021]

In two studies involving 737 participants, individuals who fear happiness perceived positive affect treatments as a poor fit for their needs, despite these treatments being designed to help them.

This suggests that people who avoid positivity may resist treatments that could be effective for them, highlighting the importance of understanding patient preferences in therapy selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individuals fearing positivity do not perceive positive affect treatments as strong fits: A novel experimental finding and replication. Bryant, JS., Gallagher, MR., Collins, AC., et al.[2023]

This study will evaluate the effectiveness of different components of Internet-based interventions for depression, involving 192 participants in a randomized controlled trial to determine the contributions of positive psychotherapeutic strategies (PPs) and behavioral activation (BA).

The trial aims to assess not only the reduction of negative symptoms but also the enhancement of positive affect and well-being, which are crucial for effective depression treatment, with follow-ups extending up to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies. Mira, A., Díaz-García, A., Castilla, D., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The absence of depressive symptoms is not the presence of wellness: validation of the Clinical Positive Affect Scale. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Positive Affect Stimulation and Sustainment (PASS) Module for Depressed Mood: A preliminary investigation of treatment-related effects. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Upregulating the positive affect system in anxiety and depression: Outcomes of a positive activity intervention. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Positive psychotherapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Positive cognitive behavior therapy in the treatment of depression: A randomized order within-subject comparison with traditional cognitive behavior therapy. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Moment-to-moment transfer of positive emotions in daily life predicts future course of depression in both general population and patient samples. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Individuals fearing positivity do not perceive positive affect treatments as strong fits: A novel experimental finding and replication. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies. [2023]