Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy

NCT05140135 | Withdrawn

• 1 other identifier: 844100
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quality of Life Scale (QLS)

  Up to 15 months after the baseline appointment

• Revised Social Anhedonia Scale (RSAS)

  Up to 15 months after the baseline appointment

• Beck Hopelessness Scale (BHS)

  Up to 15 months after the baseline appointment

• Dysfunctional Attitude Scale (DAS)

  Up to 15 months after the baseline appointment

• Road to Recovery Scale - 10 (RRS-10)

  Up to 15 months after the baseline appointment

Study Arms (2)

Recovery Oriented Cognitive Therapy (CT-R)

EXPERIMENTAL

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.

Behavioral: Recovery Oriented Cognitive Therapy (CT-R)

Continued Usual Care

ACTIVE COMPARATOR

Other: Treatment as Usual

Interventions

Recovery Oriented Cognitive Therapy (CT-R) BEHAVIORAL

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.

Recovery Oriented Cognitive Therapy (CT-R)

Treatment as Usual OTHER

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.

Continued Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Eirini Zoupou

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: January 11, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)