Supportive + Cognitive Behavioural Therapy for High Risk of Psychosis

Overseen By Cari Jahraus

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Axis I psychotic disorder, IQ < 70, CNS disorder

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will recruit 60 young people who meet established criteria for being at clinical high risk for psychosis. They will be offered a range of psychological interventions starting with the most benign treatments in different steps. At step 1 they will be offered individual or group support and if there is no improvement they will be offered more intensive CBT individual therapy or CBSST group therapy. Assessments will occur at baseline, 6,12 and 18 months

Do I need to stop my current medications to join the trial?

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.

What data supports the effectiveness of the treatment Supportive + Cognitive Behavioral Therapy for individuals at high risk of psychosis?

Research shows that Cognitive Behavioral Therapy (CBT) is effective in reducing symptoms and improving well-being in people with psychosis. It is considered a recommended treatment in many healthcare systems and has been shown to help with symptom remission and relapse prevention. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for people at high risk of psychosis?

Cognitive Behavioral Therapy (CBT) is generally considered safe for people, including those at high risk of psychosis. It has been evaluated in numerous studies and is recommended as a treatment in various health services worldwide, with a better benefit/risk ratio compared to some medications. ^{2 3 4 5 6}

How does supportive therapy differ from other treatments for high risk of psychosis?

Supportive therapy, also known as supportive counseling, focuses on providing emotional support and practical assistance, which can be less intensive than cognitive-behavioral therapy (CBT) that targets specific thought patterns. Unlike antipsychotic medications, supportive therapy offers a better benefit/risk ratio by avoiding medication side effects while still aiming to improve psychosocial functioning and quality of life. ^{3 6 7 8 9}

Research Team

Jean Addington, Ph.D.

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for young people who are at high risk of developing psychosis but haven't yet. They should not have had a psychotic disorder before, an IQ below 70, or significant brain-related health issues.

Inclusion Criteria

You have symptoms that suggest a high risk of developing psychosis.

Exclusion Criteria

You have been diagnosed with a psychotic disorder in the past or currently have symptoms that meet the criteria for a psychotic disorder.

My IQ is below 70.

I have a history of a serious brain or nerve disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Step 1 Treatment

Participants receive individual or group support therapy

1-2 months

Monthly visits (in-person)

Step 2 Treatment

Participants receive more intensive CBT individual therapy or CBSST group therapy if no improvement in Step 1

4-6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 6, 12, and 18 months

Treatment Details

Interventions

• CBT
• Supportive therapy

Trial Overview The study tests stepped care in youth at risk for psychosis. It starts with supportive therapy and can step up to intensive Cognitive Behavioral Therapy (CBT) if needed, with progress checks every 6 months.

Participant Groups

Group I: Open treatment Experimental Treatment 1 Intervention

Supportive therapy followed by CBT

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

A study involving 48 patients at clinical high risk for psychosis revealed that they prioritize subjective wellbeing and resilience as key indicators of a good outcome, which are often overlooked in traditional clinical assessments.

The research led to the development of a preliminary 12-item checklist (GO-12) that incorporates patient-defined measures of good outcomes, suggesting that including these metrics could enhance the evaluation of treatment effectiveness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining service-user perspectives for the development of a good outcome checklist for individuals at clinical high risk for psychosis. Petros, N., Cullen, AE., Vieira, S., et al.[2021]

The POSITIVE study is a large clinical trial involving 330 participants, comparing the efficacy of cognitive behavioural therapy (CBT) to supportive therapy (ST) in reducing positive symptoms of psychosis, aiming to clarify CBT's specific effectiveness.

The trial employs rigorous methodologies, including systematic recruitment and advanced statistical analysis, to ensure reliable results that could inform the implementation of psychotherapy in routine clinical care for psychotic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: the POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial. Klingberg, S., Wittorf, A., Meisner, C., et al.[2023]

Psychotherapy, particularly cognitive-behavioral therapy (CBT), is effective in preventing the transition to full-blown psychosis in individuals at clinical high risk (CHR) and in reducing relapse rates for those with a first-episode psychosis (FEP).

CBT offers a better benefit/risk ratio compared to antipsychotic medications, making it a preferred treatment option, especially when integrated into specialized early intervention services that also provide community support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based psychotherapy for the prevention and treatment of first-episode psychosis. Müller, H., Laier, S., Bechdolf, A.[2021]

Cognitive behavioural therapy for psychosis (CBTp) has been established as a recommended treatment, but meta-analyses show only modest effects compared to standard treatments, indicating that not all patients benefit equally from the therapy.

Factors like the therapeutic alliance and targeting specific psychological mechanisms (such as trauma or worry) are crucial for improving CBTp outcomes, suggesting a need for a more personalized approach to therapy that considers individual patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for psychosis: The end of the line or time for a new approach? Newman-Taylor, K., Bentall, R.[2023]

Cognitive-behavioral therapy (CBT) has been shown to effectively reduce positive symptoms of schizophrenia, such as hallucinations, and can also help prevent relapses, as supported by several studies and a meta-analysis.

Despite its proven efficacy, CBT is rarely implemented in routine clinical settings for schizophrenia patients, highlighting a gap in treatment delivery that could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapy of positive symptoms in the treatment of patients with schizophrenia psychosis]. Wiedemann, G., Klingberg, S.[2019]

A 25-session cognitive-behavioral therapy program for early psychosis showed significant improvements in psychotic symptoms among 20 patients, with effects maintained at a 6-month follow-up.

The program had a high acceptance rate of 75% and an 84% compliance rate, indicating that the treatment dosage and structure were effective in engaging participants, including adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy in early psychosis: an open study in a clinical setting]. Marois, MJ., Gingras, N., Provencher, MD., et al.[2018]

In a study of 128 outpatients at risk of developing psychosis, both specific cognitive behavior therapy (CBT) and supportive counseling (SC) improved social adjustment over 12 months, as measured by the Social Adjustment Scale II.

However, there was no significant difference in effectiveness between CBT and SC, suggesting that while both treatments are beneficial, additional support like vocational rehabilitation may be necessary for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled multicentre trial of cognitive behaviour therapy in the early initial prodromal state: effects on social adjustment post treatment. Bechdolf, A., Wagner, M., Veith, V., et al.[2018]

A study involving 26 young individuals at clinical high risk for psychosis showed that systemic therapy (ST) significantly improved positive and depressive symptoms, self-esteem, and social support after 6 months compared to supportive therapy.

The results suggest that ST can be an effective short-term intervention for enhancing psychosocial functioning in non-clinical CHR youth, although further long-term studies are necessary to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic Therapy for Youth at Clinical High Risk for Psychosis: A Pilot Study. Shi, J., Wang, L., Yao, Y., et al.[2020]

About one-third of individuals identified with psychosis risk syndromes (PRS) convert to a diagnosable psychotic disorder within three years, highlighting the importance of early identification and intervention.

Due to the high rate of false positives and limited evidence on the effectiveness of current interventions, a staged approach is recommended, prioritizing non-medication strategies like case management and psychosocial support before considering antipsychotic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How should we intervene in psychosis risk syndromes? Wang, J., Jiang, K., Zhang, T., et al.[2021]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Examining service-user perspectives for the development of a good outcome checklist for individuals at clinical high risk for psychosis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: the POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Evidence-based psychotherapy for the prevention and treatment of first-episode psychosis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for psychosis: The end of the line or time for a new approach? [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

[Psychotherapy of positive symptoms in the treatment of patients with schizophrenia psychosis]. [2019]

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

[Cognitive-behavioural therapy in early psychosis: an open study in a clinical setting]. [2018]

7. Australia pubmed.ncbi.nlm.nih.gov

Randomized controlled multicentre trial of cognitive behaviour therapy in the early initial prodromal state: effects on social adjustment post treatment. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Systemic Therapy for Youth at Clinical High Risk for Psychosis: A Pilot Study. [2020]

9. China pubmed.ncbi.nlm.nih.gov

How should we intervene in psychosis risk syndromes? [2021]