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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if altering focus and thought processes can enhance decision-making and brain functions in individuals with schizophrenia or schizoaffective disorder compared to those without these conditions. Participants will learn a positive thinking strategy, known as Positive Emotion Upregulation, and apply it during computer tasks to assess its impact on their brain and decisions. The study also examines how brain activity during these tasks correlates with real-world choices and activities. Suitable candidates for this trial include individuals with schizophrenia or schizoaffective disorder who can understand and follow study tasks. As an unphased trial, this study provides participants an opportunity to contribute to foundational research that could lead to new insights and treatments.

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 prior data suggests that this protocol is safe for participants?

Research shows that Positive Emotion Upregulation could benefit people with schizophrenia. The Positive Emotions Programme for Schizophrenia (PEPS) has significantly reduced anhedonia, helping individuals experience more pleasure. This suggests that the treatment is effective and manageable. Studies have not reported any serious side effects with this approach.

Although specific safety data for this exact method in this trial is unavailable, similar strategies have been used without major problems, which is encouraging. In this study, participants will use positive thinking during decision-making tasks, a generally safe and low-risk activity. This likely ensures safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Positive Emotion Upregulation for schizophrenia because it introduces a novel cognitive strategy aimed at enhancing positive emotions, which is quite different from typical antipsychotic medications that focus on managing symptoms like hallucinations and delusions. This approach encourages participants to actively engage their mind in a way that could improve emotional well-being and overall quality of life. By potentially offering a non-pharmacological option, this strategy could complement existing treatments and provide a new avenue for those who may not fully benefit from standard medications.

What evidence suggests that positive emotion upregulation might be an effective treatment for schizophrenia?

Research has shown that boosting positive emotions can help people with schizophrenia by reducing anhedonia, the inability to feel pleasure in life. In this trial, participants will engage in a Positive Emotion Upregulation strategy. A study on the Positive Emotions Programme for Schizophrenia found it greatly improved patients' ability to feel joy. Another study discovered that teaching people to be more aware of their emotions can help manage symptoms and reduce episodes when conditions worsen. These findings suggest that focusing on positive emotions might improve decision-making and daily life for those with schizophrenia. ^{2 6 7 8 9}

Who Is on the Research Team?

David Zald, PhD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

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 understand tasks well and have an IQ over 70.

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

Subjects without schizophrenia must not have a pervasive history of problematic substance use (other than nicotine or alcohol) as defined by meeting DSM-5 criteria for a substance use disorder

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

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