Behavioral Activation for First Episode Psychosis

Recruiting at 1 trial location

Overseen By Maria Santos, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: California State University, San Bernardino

Disqualifiers: Serious medical condition, others

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

Compensation: Varies

Number of Visits: 13

Duration: 6 months

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach called Behavioral Activation (BA) for individuals experiencing their first episode of psychosis, compared to standard community mental health care (treatment-as-usual, or TAU). The goal is to determine if BA helps participants remain more engaged in their care. Participants in both groups will also attend family sessions. The trial seeks Latino individuals diagnosed with a psychotic disorder who have experienced a first episode within the past three years. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mental health care for others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Behavioral Activation for First Episode Psychosis is safe?

Research shows that behavioral activation (BA) is generally safe for individuals experiencing their first episode of psychosis (FEP). Previous studies have examined BA as a method to alleviate symptoms of depression and psychosis. These studies found that BA is usually well-tolerated, with few serious side effects. For instance, one study focused on BA for individuals with negative symptoms of schizophrenia, similar to those in FEP. This study reported no major negative effects, suggesting that BA can be a safe option for many.

In summary, the evidence so far indicates that BA is a safe treatment for people with first-episode psychosis. Participants have generally managed the treatment well, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation for First Episode Psychosis because it offers a fresh approach to helping patients manage their symptoms. Unlike typical treatments for psychosis, which often focus on medication and symptom stabilization, this method emphasizes engaging patients in meaningful activities to improve their mood and functioning. By targeting behavioral patterns and encouraging positive actions, this approach has the potential to enhance overall well-being and reduce the impact of psychotic episodes, offering a promising complement to traditional care.

What evidence suggests that Behavioral Activation might be an effective treatment for first-episode psychosis?

Research has shown that Behavioral Activation (BA), which participants in this trial may receive, can be as effective as cognitive therapy for treating depression, often occurring in first-episode psychosis (FEP). Participants in BA studies tend to adhere to the treatment, resulting in noticeable improvements. Previous research found that BA helps reduce depression and increases engagement with mental health services. This is encouraging because better engagement can lead to improved overall outcomes in managing FEP. While this trial specifically studies BA for FEP, these early findings suggest it could be effective for this condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Maria Santos, PhD

Principal Investigator

California State University, San Bernardino

Are You a Good Fit for This Trial?

This trial is for Latinos aged 15-35 with a first episode of psychosis, who can speak English or Spanish. They must have a caregiver willing to participate and be able to give informed consent. Excluded are those with psychosis due to other medical conditions or substance use, serious medical issues, or more than three years since their first psychotic episode.

Inclusion Criteria

I can speak English or Spanish.

I am between 15 and 35 years old.

Self-identification as Latino

Exclusion Criteria

My psychosis is caused by another health issue or medication.

3≤ years after the onset

I have a serious health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Assessment

Pre-intervention assessment to establish baseline measures

1-2 weeks

Treatment

Participants receive either Behavioral Activation (BA) or Treatment as Usual (TAU) over 6 months

6 months

Up to 12 sessions

Post-intervention Assessment

Assessment of outcomes immediately after the intervention phase

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 1-month and 6-month post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation for First Episode Psychosis
• Treatment As Usual

Trial Overview The study compares a special 12-session program called Behavioral Activation (BA) designed for new cases of psychosis against the usual mental health care over six months. Both groups will also have family sessions. The goal is to see if BA helps patients engage better in their treatment.

How Is the Trial Designed?

Group I: Behavioral Activation for First Episode Psychosis Experimental Treatment 1 Intervention

Patients will receive BA for FEP in individual session format provided by the PI based on a manual adapted for this study.

Group II: Treatment at Usual Active Control 1 Intervention

Patients randomized to TAU will receive typical clinic care offered beyond psychiatric services.

Behavioral Activation for First Episode Psychosis is already approved in United States, European Union for the following indications:

Approved in United States as Behavioral Activation for:

• Depression
• First-Episode Psychosis

Approved in European Union as Behavioral Activation for:

• Depression

Who Is Running the Clinical Trial?

California State University, San Bernardino

Lead Sponsor

Trials

3

Recruited

4,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Olive View-UCLA Education & Research Institute

Collaborator

Trials

34

Recruited

880,000+

Published Research Related to This Trial

This pilot study aims to assess the feasibility of using clinician-delivered behavioral activation as an additional treatment for depression in approximately 60 young people with early/emerging psychosis, focusing on their depressive symptoms and overall functioning.

The study will evaluate clinician training completion, participant consent rates, and treatment fidelity, with the goal of informing a larger randomized controlled trial to better understand the efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural activation for depressive symptoms in young people with emerging or early psychosis: A pilot study protocol. Byrne, MK., Easpaig, BNG., Gray, R., et al.[2023]

The motivational and behavioral activation (mBA) approach was found to be feasible and effective in reducing negative symptoms of schizophrenia in a pilot study with 73 participants, showing large effects compared to usual psychiatric rehabilitation.

Participants receiving mBA also demonstrated improvements in verbal learning and memory, suggesting that this approach may enhance cognitive functioning alongside addressing negative symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational and Behavioral Activation as an Adjunct to Psychiatric Rehabilitation for Mild to Moderate Negative Symptoms in Individuals with Schizophrenia: A Proof-of-Concept Pilot Study. Choi, KH., Jaekal, E., Lee, GY.[2020]

In a study of 236 first-episode psychosis patients, significant improvements were observed in functional recovery measures during treatment, such as reduced unemployment and enhanced quality of life, but no changes in symptom severity were noted.

One-third of the patients (33%) disengaged from treatment, with higher rates of disengagement associated with unemployment and poorer baseline psychosocial functioning, indicating a need for targeted interventions to retain these individuals in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes for 236 patients from a 2-year early intervention in psychosis service. Turner, MA., Boden, JM., Smith-Hamel, C., et al.[2019]

A study involving 99 participants with recent diagnoses of schizophrenia showed that a combination of cognitive-behavioral therapy focused on social activation (CBTsa) led to significant short-term improvements in symptom severity and functioning compared to standard treatment alone.

However, these benefits did not persist at the 6-month follow-up, suggesting that longer treatment durations may be necessary to achieve lasting changes in negative symptoms and dysfunctional beliefs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for social activation in recent-onset psychosis: Randomized controlled trial. Pos, K., Franke, N., Smit, F., et al.[2020]

Antipsychotic medications are effective for both acute and maintenance treatment in patients experiencing their first episode of psychosis, as supported by recent studies that have improved methods for defining illness onset and treatment response.

Early intervention is crucial, as patients often endure 12 to 24 months of untreated psychosis, which can lead to poorer treatment outcomes; using newer antipsychotics may enhance efficacy and reduce side effects, promoting better medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation and treatment of first-episode psychosis. Sheitman, BB., Lee, H., Strous, R., et al.[2022]

The Graduated Recovery Intervention Program (GRIP) was found to be well-tolerated and feasible for individuals with first episode psychosis, as shown by good attendance and low dropout rates among the 46 participants.

While the overall results were not statistically significant, there were indications that GRIP may improve functional outcomes compared to treatment as usual (TAU), suggesting it could be a promising intervention for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot investigation of the Graduated Recovery Intervention Program (GRIP) for first episode psychosis. Penn, DL., Uzenoff, SR., Perkins, D., et al.[2021]

A randomized controlled trial involving 81 patients aged 15 to 25 with first-episode psychosis showed that a multimodal cognitive-behavioral therapy for relapse prevention significantly reduced relapse rates compared to standardized case management, with a p-value of 0.042.

Patients receiving the relapse prevention therapy also experienced a longer time to their first relapse (p = 0.03), indicating that this approach may be more effective in managing early psychosis than traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of relapse prevention therapy for first-episode psychosis patients. Gleeson, JF., Cotton, SM., Alvarez-Jimenez, M., et al.[2019]

In a study of 172 patients with first-episode nonaffective psychosis, haloperidol, risperidone, and olanzapine were found to be equally effective in reducing psychotic symptoms after 6 weeks of treatment, with no significant differences in response rates among the three medications.

Haloperidol was associated with a higher frequency of extrapyramidal symptoms and the need for anticholinergic medications compared to olanzapine and risperidone, while olanzapine led to significantly more weight gain, highlighting important safety and tolerability considerations in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A practical clinical trial comparing haloperidol, risperidone, and olanzapine for the acute treatment of first-episode nonaffective psychosis. Crespo-Facorro, B., Pérez-Iglesias, R., Ramirez-Bonilla, M., et al.[2019]

In a study involving 404 individuals with first-episode psychosis, the NAVIGATE program, which included a substance abuse component, did not significantly reduce self-reported substance use compared to usual care over a two-year follow-up period.

Despite a high prevalence of substance use disorders among participants (51.7%), the low engagement with the substance abuse content in the NAVIGATE program suggests that improvements in program delivery and clinician training are necessary to effectively address these co-occurring disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of comprehensive treatment for first episode psychosis on substance use outcomes: A randomized controlled trial. Cather, C., Brunette, MF., Mueser, KT., et al.[2019]

Behavioral activation (BA) significantly reduced negative symptoms in patients with schizophrenia when combined with treatment-as-usual (TAU), as shown by improved scores on the Clinical Assessment Interview for Negative Symptoms (CAINS) and other scales in a study of 70 participants.

Although BA showed immediate benefits post-treatment, these improvements were not maintained at the six-month follow-up, indicating the need for further research to understand how to sustain these positive effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based multi-site randomized controlled trial of behavioral activation for patients with negative symptoms of schizophrenia. Oh, J., Lee, E., Cha, EJ., et al.[2023]

Improving the quality of mental health care and reducing the delay in treatment for individuals with first-episode psychosis can significantly enhance their outcomes, as evidenced by the review of strategies targeting these areas.

Multicomponent treatment packages that address multiple needs and are initiated early after the onset of symptoms show promising effects, but further optimization of psychosocial interventions is necessary to achieve better clinical and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing psychosocial interventions in first-episode psychosis: current perspectives and future directions. Breitborde, NJ., Moe, AM., Ered, A., et al.[2020]

Early and preventive interventions for patients with first-episode psychosis can lead to better outcomes, as studies show that longer untreated psychosis is linked to poorer results.

Using lower doses of atypical antipsychotic medications and incorporating psychological support tailored to young patients and their families can enhance treatment effectiveness and reduce side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing function after first-episode psychosis. Kopala, LC.[2022]

A pilot evaluation of behavioral activation (BA) treatment in eight individuals with psychosis and significant negative symptoms showed promising feasibility and effectiveness, suggesting it could be a viable intervention.

The study indicates that BA, which is known to be effective for depression, may also help improve negative symptoms in psychosis, although further refinements to the treatment approach could enhance its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot investigation of behavioral activation for negative symptoms. Mairs, H., Lovell, K., Campbell, M., et al.[2011]

In a study of 94 patients with first-episode schizophrenia spectrum disorders, those receiving hospital-based rehabilitation spent significantly more time in psychiatric wards and supported housing over a 5-year follow-up compared to those receiving specialized assertive intervention or standard treatment.

The findings suggest that hospital-based rehabilitation, combined with weekly supportive psychodynamic therapy, may not be effective for reducing institutional care use in first-episode psychosis, indicating it may not be a justified treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deinstitutionalization revisited: a 5-year follow-up of a randomized clinical trial of hospital-based rehabilitation versus specialized assertive intervention (OPUS) versus standard treatment for patients with first-episode schizophrenia spectrum disorders. Nordentoft, M., Øhlenschlaeger, J., Thorup, A., et al.[2010]

New generation antipsychotics like olanzapine and risperidone show a lower rate of early dropout compared to haloperidol in first-episode schizophrenia patients, indicating better tolerability; however, the overall efficacy compared to conventional antipsychotics remains inconclusive based on the limited studies reviewed (total n=266).

Patients receiving olanzapine experienced significantly fewer extrapyramidal side effects and required less anticholinergic medication compared to those on haloperidol, suggesting a safety advantage for new generation antipsychotics, but the long-term benefits and overall treatment compliance are still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New generation antipsychotics for first episode schizophrenia. Rummel, C., Hamann, J., Kissling, W., et al.[2018]

Citations

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Behavioural activation for depressive symptoms in young ... There is clear evidence that Cognitive Behavioural Therapy (CBT) can be effective at treating depression in YPEEP [12–14]. However, CBT is a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05310838?tab=table

Optimizing Engagement in Services for First-Episode ... This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care ( ...

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A randomised controlled feasibility trial of Behavioural ... Participants showed strong adherence to the BA, with over 90 % data completeness for outcomes, including depression severity and HbA1c levels.

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(PDF) Behavioural activation for depressive symptoms in ... Conclusion: Our sample was higher functioning, younger and experiencing lower levels of psychotic like experiences than other trials. The ...

5. link.springer.com link.springer.com/article/10.1007/s41811-019-00044-8

Is Behavioral Activation (BA) More Effective than Cognitive ... A landmark study (Jacobson et al., JCCP, 64:295–304, 1996) suggested that behavioral activation (BA) is as effective as cognitive therapy (CT) in the treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10962362/

Identification of Psychosis Risk and Diagnosis of First-Episode ... Negative symptoms can include reductions in motivation and interest, decreased social drive and social behavior, diminished emotional experience ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996422004984

Community-based multi-site randomized controlled trial of ... This study aimed to explore BA as an effective intervention for relieving the negative symptoms of schizophrenia.