Cognitive Therapy for Schizophrenia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Antipsychotics

Disqualifiers: Brain damage, Suicidal risk, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special therapy called Recovery Oriented Cognitive Therapy (CT-R) for individuals with schizophrenia or schizoaffective disorder. The researchers aim to determine if CT-R, combined with regular treatment, improves symptoms and quality of life. Participants will be randomly assigned to either continue their usual care or receive CT-R for about nine months. The trial seeks individuals diagnosed with schizophrenia or schizoaffective disorder who are already receiving medical treatment. As an unphased trial, it offers a unique opportunity to contribute to understanding innovative therapies that could enhance treatment options.

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

No, you do not need to stop your current medications. The study involves adding cognitive therapy to your existing treatment.

What prior data suggests that recovery oriented cognitive therapy (CT-R) is safe for patients with schizophrenia/schizoaffective disorder?

Research shows that Recovery Oriented Cognitive Therapy (CT-R) is generally well-received by people with serious mental health issues. Studies have demonstrated that it is a proven method, having been tested and supported by research. CT-R focuses on improving well-being and empowerment by helping individuals pursue their goals and engage in meaningful activities.

No specific reports of negative effects or side effects from CT-R have emerged, suggesting it is safe for patients. As a type of talk therapy, CT-R does not involve medication, often resulting in fewer physical side effects. Overall, CT-R appears to be a safe choice for those seeking to enhance their mental health and recovery journey. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Recovery Oriented Cognitive Therapy (CT-R) is unique because it emphasizes personal aspirations and meaningful activities to drive recovery, unlike traditional treatments that often focus primarily on symptom management. This approach activates positive cognitions, emotions, and motivation by engaging individuals in activities that matter to them, fostering a more holistic recovery. Researchers are excited about CT-R because it has the potential to not only alleviate symptoms but also enhance overall life satisfaction and personal growth for individuals.

What evidence suggests that Recovery Oriented Cognitive Therapy (CT-R) is effective for schizophrenia/schizoaffective disorder?

Research has shown that Recovery Oriented Cognitive Therapy (CT-R), tested in this trial, can assist people with schizophrenia. In past studies, participants who received CT-R alongside their usual treatment demonstrated better daily functioning, increased motivation, and fewer symptoms such as auditory or visual hallucinations. Another study found that CT-R improved patients' quality of life over time. This therapy encourages involvement in meaningful activities and supports personal goal achievement. The results suggest that CT-R can significantly enhance the lives of those living with schizophrenia. Participants in this trial will either receive CT-R or continue with their usual care. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Therapists: 25 years of age or above, licensed therapist, preliminarily trained in CT-R.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Therapists complete a training phase consisting of a workshop and approximately 3 months of group supervision while providing CT-R to 1 training case each

3 months

Treatment

Participants receive Recovery Oriented Cognitive Therapy (CT-R) in weekly sessions for approximately 9 months

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Recovery Oriented Cognitive Therapy (CT-R)

How Is the Trial Designed?

Group I: Recovery Oriented Cognitive Therapy (CT-R) Experimental Treatment 1 Intervention

Therapists implement CT-R in weekly sessions for approximately 9 months while supported by a clinical supervisor. Therapists will have completed a supervised CT-R training case prior to the initiation of the randomized controlled trial. CT-R will focus on strengthening aspirations and focusing on activities that can bring about one's desired life. The therapist will use techniques to engage the patient in the adaptive mode, which involves activating cognitions, affects, motivation, and behaviors by engaging the individual in personally meaningful activities.

Group II: Continued Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Cognitive therapy (CT) is significantly more effective than waiting-list controls and antidepressants for treating mild to moderate depression, based on a meta-analysis of 48 high-quality trials involving 2765 patients.

CT may also help prevent relapses in the long term, suggesting it could be a more sustainable treatment option compared to antidepressants, which have higher relapse rates in naturalistic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the effects of cognitive therapy in depressed patients. Gloaguen, V., Cottraux, J., Cucherat, M., et al.[2022]

Cognitive therapy (CT) has evolved into a broad scientific approach that includes various disorder-specific interventions, making it adaptable for different psychological disorders.

The article reviews the efficacy and validity of CT, highlighting its effectiveness in treating conditions like posttraumatic stress disorder and health anxiety, while also noting the differences and similarities in treatment approaches for these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The science of cognitive therapy. Hofmann, SG., Asmundson, GJ., Beck, AT.[2018]

In a study of 420 veterans with PTSD, those receiving Seeking Safety (SS) had a higher treatment completion rate (89%) compared to those receiving cognitive processing therapy (CPT) (50%), indicating SS may be more acceptable for veterans.

However, veterans who completed CPT showed significantly greater reductions in PTSD symptoms, as measured by the PTSD checklist, suggesting that while SS is easier to complete, CPT may be more effective in reducing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. Baig, MR., Ouyang, S., Mata-Galán, E., et al.[2021]

Citations

1.

beckinstitute.org

beckinstitute.org/wp-content/uploads/2021/06/CT-R-Research-Summary.pdf

Recovery-Oriented Cognitive Therapy: Research Summary

Results revealed that individuals in the standard treatment + CT-R group had better functioning, more motivation and a decrease in positive symptoms. Page 3 ...

2.

psychiatryonline.org

psychiatryonline.org/doi/10.1176/appi.ps.201600413

Six-Month Follow-Up of Recovery-Oriented Cognitive ...

The study examined six-month follow-up results and the impact of length of illness on treatment outcomes of recovery-oriented cognitive ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6738704/

Cognitive–behavioural therapy for personal recovery of ...

The results showed that the CBT programme improved the patients' psychological health-related QoL with a small effect size (Cohen's d=0.03). Moreover, the long- ...

4.

psychiatrictimes.com

psychiatrictimes.com/view/recovery-oriented-cognitive-therapy-changing-lives-with-a-whole-person-approach

Recovery-Oriented Cognitive Therapy: Changing Lives ...

In program evaluation studies, CT-R has been associated with reduction in the use of coercive control methods, 22 an increase in number of days ...

5.

withpower.com

withpower.com/trial/phase-schizophrenia-2021-5cdaf

Effectiveness and Mechanisms of Recovery Oriented ...

Research shows that Recovery Oriented Cognitive Therapy (CT-R) can be effective for people with schizophrenia, as a study found positive outcomes six months ...

6.

nasmhpd.org

nasmhpd.org/wp-content/uploads/mon-july-28-430-515-recovery-oriented-cognitive-therapy.pdf

Recovery-Oriented Cognitive Therapy (CT-R)

We offer training and dissemination of Recovery-Oriented. Cognitive Therapy and Cognitive Behavior Therapy to health and mental health ...

7.

beckinstitute.org

beckinstitute.org/wp-content/uploads/2021/09/TAC_Paper_7_508C_0.pdf

Recovery-Oriented Cognitive Therapy: a Theory-Driven, ...

Recovery-Oriented Cognitive Therapy (CT-R) is a theory-driven, empirically-supported approach for promoting recovery and resiliency in individuals ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06653829

NST-SPARK: Preliminary Study of an Augmented Reality ...

This is an augmented reality (AR) mobile phone application that uses Recovery-oriented Cognitive Therapy (CT-R) to target negative symptoms of schizophrenia.

9.

psychwire.com

psychwire.com/free-resources/q-and-a/s8fbr4/benefits-of-recovery-oriented-cognitive-therapy

Benefits of Recovery-Oriented Cognitive Therapy

CT-R was developed using a specific cognitive model that conceptualizes negative symptoms as coming from unhelpful and inaccurate beliefs.