Clinical trial NCT05140135: Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy
Official title: Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Up to 15 months after the baseline appointment
Secondary outcomes:
measure: Quality of Life Scale (QLS)
timeFrame: Up to 15 months after the baseline appointment
measure: Revised Social Anhedonia Scale (RSAS)
timeFrame: Up to 15 months after the baseline appointment
measure: Beck Hopelessness Scale (BHS)
timeFrame: Up to 15 months after the baseline appointment
measure: Dysfunctional Attitude Scale (DAS)
timeFrame: Up to 15 months after the baseline appointment
measure: Road to Recovery Scale - 10 (RRS-10)
timeFrame: Up to 15 months after the baseline appointment
measure: Beck Self-Esteem Scale - Short Form (BSES-SF)
timeFrame: Up to 15 months after the baseline appointment
measure: Internalized Stigma of Mental Illness Inventory-29 (ISMI-29)
timeFrame: Up to 15 months after the baseline appointment
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Up to 15 months after the baseline appointment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Eirini Zoupou
state: Pennsylvania
Study officials:
References: