Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy

Schizophrenia Clinical Trial

Official title:

Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05140135
• Other study ID #: 844100
• Status: Withdrawn
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is evaluating the effectiveness of recovery oriented cognitive therapy (CT-R) for patients with schizophrenia/schizoaffective disorder. To evaluate CT-R, the investigators are conducting a randomized controlled trial with patients from community mental health centers. Participants will be randomized to the CT-R condition, in which the participants will receive approximately 9 months of CT-R as an adjunctive treatment to current medical treatment, or to the continued usual care control condition.

The primary outcome measure (positive, negative, and general psychopathology symptoms) as well as secondary measures (quality of life, self-esteem, social anhedonia, recovery, dysfunctional attitudes, resilience, internalized stigma, and hopelessness) will be measured at baseline, 4-5 months after the first therapy appointment, approximately 9 months after the first therapy appointment, and approximately 15 months after the baseline appointment.

Description:

Background/Purpose: Despite effective medical treatment, many patients with psychotic illnesses experience poor long-term functional outcomes possibly due to certain psychosocial factors that can interfere with recovery. CT-R was developed to address these factors by leading the individual to substantive progress by addressing any obstacles and promoting a cognitive shift in their beliefs in their own personal and social efficacy. The goal of this study is to evaluate the effectiveness and mechanisms of CT-R as an adjunctive treatment for individuals with schizophrenia/schizoaffective disorder.

Population: Participants will include individuals currently receiving pharmacological treatment for schizophrenia or schizoaffective disorder. Therapist participants who have preliminary training in CT-R will be recruited as well to deliver the treatment. Therapists will first complete a training phase consisting of a workshop and approximately 3 months of group supervision while providing CT-R to 1 training case each.

Intervention: The CT-R that will be implemented in the present study will focus on strengthening aspirations and focusing on activities that can bring about one's desired life. In CT-R, clinicians use techniques to engage the patient in the adaptive mode, which includes cognitions, affects, motivation, and behaviors that are activated when the individual is engaged in personally meaningful activities.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients: Between 18 and 65 years old with a diagnosis of schizophrenia or schizoaffective disorder, proficient in English, currently under the care of a physician and on medication for schizophrenia/schizoaffective disorder, and able to provide informed consent.

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

Exclusion Criteria:

• Patients: Medical comorbidities causing brain damage (e.g., stroke, dementia), significant suicidal risk/ideation requiring immediate referral or suicidal gesture.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Recovery Oriented Cognitive Therapy (CT-R)
The CT-R that will be implemented in the present study will focus on strengthening aspirations and focusing on activities that can bring about one's desired life. In CT-R, clinicians use techniques to engage the patient in the adaptive mode, which includes cognitions, affects, motivation, and behaviors that are activated when the individual is engaged in personally meaningful activities.

Other:
• Treatment as Usual
All patients enrolled in the study who are randomized to the continued care as usual condition will continue to receive the treatments from their physician/treatment team at the Community Mental Health Center; however, they will not receive the adjunctive CT-R treatment.

Locations

Country	Name	City	State
United States	Eirini Zoupou	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)	Assesses positive, negative, and general psychopathology symptoms associated with schizophrenia. Consists of 33 items each rated on a scale from 1 (absent) to 7 (extreme).	Up to 15 months after the baseline appointment
Secondary	Quality of Life Scale (QLS)	Measures quality in life of individuals living with schizophrenia and functioning. Total scores range from 0-126. Lower scores indicate lower quality of life and functioning.	Up to 15 months after the baseline appointment
Secondary	Revised Social Anhedonia Scale (RSAS)	Questionnaire assessing attitudes and preferences related to spending time with other people. Total score ranges from 0 to 20. Higher scores indicate a preference to spend time alone.	Up to 15 months after the baseline appointment
Secondary	Beck Hopelessness Scale (BHS)	Questionnaire measuring the extent of positive and negative beliefs about the future. Total score ranges from 0 to 20. Higher scores indicate higher levels of hopelessness.	Up to 15 months after the baseline appointment
Secondary	Dysfunctional Attitude Scale (DAS)	Self-report measure assessing levels of dysfunctional attitudes. It consists of 7 subscales for a total of 40 items. Each item is rated on a scale from 1 (totally agree) to 7 (totally disagree).	Up to 15 months after the baseline appointment
Secondary	Road to Recovery Scale - 10 (RRS-10)	Measures multi-faceted areas of recovery. Each item is rated on a 1-5 scale. Total score is averaged across items and ranges from 1 to 5. Higher scores indicate more pro-recovery behaviors.	Up to 15 months after the baseline appointment
Secondary	Beck Self-Esteem Scale - Short Form (BSES-SF)	Assesses beliefs about the self and others' impressions of the self. The 10-item version of the scale consists of 10 bipolar adjectives rated on a 10-point scale (anchors are "very much" for 1 and 10; "average" for 5 and 6).	Up to 15 months after the baseline appointment
Secondary	Internalized Stigma of Mental Illness Inventory-29 (ISMI-29)	Self-report instrument designed to measure the overall strength of respondents' internalized stigma of mental illness among persons with psychiatric disorders. Total score ranges from 29-116. Higher scores indicate greater levels of internalized stigma.	Up to 15 months after the baseline appointment
Secondary	Connor-Davidson Resilience Scale (CD-RISC)	Self-report measure designed to assess resilience. It also differentiates between patients with schizophrenia and healthy controls. Total scores range from 0 to 100, with higher scores indicating greater resilience.	Up to 15 months after the baseline appointment