Positive Emotion Upregulation for Schizophrenia

Overseen By David H Zald, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Substance use, Neurological disease, Epilepsy, others

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

Compensation: Varies

Number of Visits: 2

74 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that currently untreated or unstable psychiatric and medical conditions are exclusion criteria, which might imply that stable medication use is allowed.

What data supports the effectiveness of the treatment Positive Emotion Upregulation for schizophrenia?

Research shows that the Positive Emotions Program for Schizophrenia (PEPS), which is similar to Positive Emotion Upregulation, effectively reduces negative symptoms like anhedonia (inability to feel pleasure) and apathy, and improves social functioning in people with schizophrenia. ^{1 2 3 4 5}

Is Positive Emotion Upregulation safe for humans?

The Positive Emotions Program for Schizophrenia (PEPS) has been tested in studies with participants who completed all sessions without reported safety issues, suggesting it is generally safe for humans. ^{3 5 6 7 8}

How does the Positive Emotion Upregulation treatment differ from other treatments for schizophrenia?

The Positive Emotion Upregulation treatment, also known as the Positive Emotions Program for Schizophrenia (PEPS), is unique because it focuses on enhancing positive emotions and developing positive performance beliefs, which helps reduce negative symptoms like anhedonia (inability to feel pleasure) and apathy. Unlike traditional drug treatments, PEPS involves emotion regulation strategy training through sessions, leading to improved social functioning and reduced negative symptoms. ^{3 4 6 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to learn if attention and ways of thinking impact decision-making and brain processes related to decision-making in people with schizophrenia or schizoaffective disorder relative to people without either condition. It will also learn how brain functioning during decision-making relates to real-world decisions made during daily life. The main questions it aims to answer are: * Does paying attention to specific information impact decision-making and brain processes? * Does thinking in a certain way according to specific 'thinking strategies' improve brain processes related to decision-making? * Does brain functioning during decision-making relate to real-world choices to engage in activities? Researchers will compare brain functioning and decision-making on computer tasks of gambling after participants have been trained to use a positive thinking strategy. They will compare what is different in the brain and behavior when participants use this strategy and when they do not. Participants will also answer brief surveys about activities and feelings for a week in their daily lives. Participants will: * Complete several hours of clinical interviewing, cognitive tests, and surveys of about symptoms, experiences, and personality * Complete computer tasks about gambling decisions during MRI brain scanning and while having their visual attention measured using eye-tracking * Complete brief surveys about their activities and feelings 5 times a day for 1 week using a cell phone. Each survey only take several minutes.

Research Team

David Zald, PhD

Principal Investigator

Rutgers University

Eligibility Criteria

This trial is for individuals with schizophrenia or schizoaffective disorder, as well as healthy controls without these conditions. Participants will undergo clinical interviews, cognitive tests, and surveys. They must be willing to complete computer tasks during MRI scans and eye-tracking sessions, and answer brief surveys on a cell phone multiple times a day for one week.

Inclusion Criteria

I understand and can agree to the study's procedures and risks.

Subjects with schizophrenia/schizoaffective disorder must have a primary diagnosis of schizophrenia or schizoaffective disorder

I match a psychiatric group in age, sex, race/ethnicity, and education but don't have schizophrenia.

Exclusion Criteria

Subjects must not have self-disclosure of consistent current substance use other than nicotine, alcohol, or cannabis

Subjects must not have a many-year history of severely disordered substance use other than nicotine/tobacco

I have never undergone electroconvulsive therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cognitive Testing and Training

Participants complete clinical interviews, cognitive tests, and surveys about symptoms, experiences, and personality. They are trained to use a positive thinking strategy.

Several hours

1 visit (in-person)

Neuroimaging and Behavioral Tasks

Participants complete computer tasks about gambling decisions during MRI brain scanning and eye-tracking.

1.5 hours

1 visit (in-person)

Experience Sampling

Participants complete brief surveys about their activities and feelings 5 times a day for 1 week using a cell phone.

1 week

Follow-up

Participants are monitored for any changes in decision-making and brain processes after the intervention.

4 weeks

Treatment Details

Interventions

• Positive Emotion Upregulation

Trial Overview The study investigates how attention and positive thinking strategies affect decision-making and brain activity in people with schizophrenia compared to those without it. It examines the impact of these strategies on gambling decisions during computer tasks under MRI observation and real-world choices via daily surveys.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

There is only 1 arm in this study. In this arm of the study, participants are instructed to implement a cognitive strategy (i.e., way of thinking) during 1/2 of the trials of a behavioral, gambling task. On the other 1/2 of the trials they behave naturally without implementing the cognitive strategy.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Maladaptive cognitive emotion regulation strategies, such as rumination, worry, and suppression, are linked to increased positive symptoms in schizophrenia spectrum disorders, suggesting that how individuals manage their emotions can significantly impact their symptoms.

Global emotion dysregulation is associated with both positive and negative symptoms, indicating that addressing emotion regulation in psychological treatments may be beneficial for improving overall symptom management in individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of emotion dysregulation on positive and negative symptoms in schizophrenia spectrum disorders: A systematic review. Liu, J., Chua, JJ., Chong, SA., et al.[2021]

In a study of 56 individuals with schizophrenia over 12 years, no initial correlation was found between the duration of untreated psychosis (DUP) and expressed emotion (EE) at the start of treatment.

Individuals with a short DUP and high EE experienced more rehospitalizations compared to those with low EE, while those with a long DUP had increased rehospitalizations regardless of EE level, indicating that both DUP and EE interact to influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of two predictors' interaction on short- and long-term treatment outcomes of schizophrenia]. Cechnicki, A., Bielańska, A., Daren, A., et al.[2019]

The Positive Emotions Program for Schizophrenia (PEPS) was found to be feasible and effective in a natural setting, significantly improving negative symptoms like anhedonia and apathy in 21 participants after eight sessions.

Participants also showed enhanced social functioning, indicating that PEPS not only reduces negative symptoms but may also help improve overall quality of life for individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Positive Emotion Regulation Training on Negative Symptoms and Social Functioning in Schizophrenia: A Field Test. Favrod, J., Nguyen, A., Tronche, AM., et al.[2020]

Schizophrenia patients can experience positive emotions when exposed to strong stimuli, but they show a reduced tendency to feel positive emotions in neutral or weak stimulus situations, known as a diminished 'positivity offset'.

This reduction in positivity offset may contribute to difficulties in motivation and approach behaviors towards new experiences, suggesting a nuanced understanding of emotional experience in schizophrenia beyond just anhedonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THE POSITIVITY OFFSET THEORY OF ANHEDONIA IN SCHIZOPHRENIA. Strauss, GP., Frost, KH., Lee, BG., et al.[2020]

The Positive Emotions Program for Schizophrenia (PEPS) is a new, group-based intervention designed to specifically target and improve the diminished capacity to experience positive emotions in individuals with schizophrenia.

PEPS is user-friendly, recovery-oriented, and has been beta-tested with healthcare professionals, making it a promising tool for enhancing pleasure and motivation in patients with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the Positive Emotions Program for Schizophrenia: An Intervention to Improve Pleasure and Motivation in Schizophrenia. Nguyen, A., Frobert, L., McCluskey, I., et al.[2020]

The Positive Emotions Programme for Schizophrenia (PEPS) significantly reduces anhedonia in patients with schizophrenia, as shown by improved scores on the Scale for the Assessment of Negative Symptoms (SANS) after 8 weeks and sustained improvements at a 6-month follow-up.

In a study of 80 participants, those receiving PEPS alongside treatment as usual (TAU) demonstrated greater clinical improvements in anhedonia compared to those receiving only TAU, highlighting PEPS as an effective and easily implementable intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Pleasure and Motivation in Schizophrenia: A Randomized Controlled Clinical Trial. Favrod, J., Nguyen, A., Chaix, J., et al.[2020]

In a study of 46 drug-free patients with schizophrenia, researchers found no overall correlation between negative and positive symptoms across various diagnostic systems, suggesting that these symptoms may not be distinct categories for all patients.

However, within specific subtypes like paranoid and undifferentiated schizophrenia, a positive correlation was observed, indicating that symptom relationships can vary based on patient classification and treatment history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive and negative symptoms in schizophrenia. Rosen, WG., Mohs, RC., Johns, CA., et al.[2019]

Negative symptoms in schizophrenia can be measured effectively using the Positive And Negative Syndrome Scale (PANSS), which helps in understanding and reporting these symptoms more clearly.

Current treatments under investigation, such as dopamine agonists and combined serotonin/dopamine antagonists like clozapine and risperidone, show promise in alleviating negative symptoms, but more well-controlled clinical trials are needed to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New pharmacotherapeutic modalities for negative symptoms in psychosis. Lindenmayer, JP.[2019]

In a study involving a large sample of schizophrenia patients and healthy controls, patients showed increased activation in the right amygdala when processing negative emotions and reduced activation during positive emotions, indicating altered emotional processing.

The study also found that medication status affects the activation of the ventral anterior cingulate cortex during negative emotional stimuli, suggesting that treatment may influence emotional experiences in schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered amygdala activation in schizophrenia patients during emotion processing. Pankow, A., Friedel, E., Sterzer, P., et al.[2016]

Individuals at ultrahigh-risk (UHR) for psychosis show reduced emotional reactivity, experiencing less positive emotion to pleasant stimuli and less negative emotion to unpleasant stimuli compared to healthy controls, based on a study involving 29 UHR participants and 32 healthy controls.

The diminished positive emotional response in UHR individuals is linked to higher levels of depression and anxiety, indicating that mood and anxiety symptoms may influence their emotional experiences differently than in those with chronic schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroleptic-free youth at ultrahigh risk for psychosis evidence diminished emotion reactivity that is predicted by depression and anxiety. Gruber, J., Strauss, GP., Dombrecht, L., et al.[2018]

References

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

The impact of emotion dysregulation on positive and negative symptoms in schizophrenia spectrum disorders: A systematic review. [2021]

2. Poland pubmed.ncbi.nlm.nih.gov

[The effect of two predictors' interaction on short- and long-term treatment outcomes of schizophrenia]. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Positive Emotion Regulation Training on Negative Symptoms and Social Functioning in Schizophrenia: A Field Test. [2020]

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

THE POSITIVITY OFFSET THEORY OF ANHEDONIA IN SCHIZOPHRENIA. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Development of the Positive Emotions Program for Schizophrenia: An Intervention to Improve Pleasure and Motivation in Schizophrenia. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Improving Pleasure and Motivation in Schizophrenia: A Randomized Controlled Clinical Trial. [2020]

7. Ireland pubmed.ncbi.nlm.nih.gov

Positive and negative symptoms in schizophrenia. [2019]

8. Denmark pubmed.ncbi.nlm.nih.gov

New pharmacotherapeutic modalities for negative symptoms in psychosis. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Altered amygdala activation in schizophrenia patients during emotion processing. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroleptic-free youth at ultrahigh risk for psychosis evidence diminished emotion reactivity that is predicted by depression and anxiety. [2018]