Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 10:41 PM
Ignite Modification Date: 2025-12-24 @ 10:41 PM
NCT ID: NCT05140135
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.
Study: NCT05140135
Study Brief:
Protocol Section: NCT05140135