search
Back to results

Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Oriented Cognitive Therapy (CT-R)
Treatment as Usual
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eirini Zoupou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recovery Oriented Cognitive Therapy (CT-R)

Continued Usual Care

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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).
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.
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).
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.
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.

Full Information

First Posted
November 17, 2021
Last Updated
May 24, 2022
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT05140135
Brief Title
Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy
Official Title
Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The funds used to originally support the study were withdrawn.
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovery Oriented Cognitive Therapy (CT-R)
Arm Type
Experimental
Arm Description
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.
Arm Title
Continued Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Recovery Oriented Cognitive Therapy (CT-R)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
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).
Time Frame
Up to 15 months after the baseline appointment
Secondary Outcome Measure Information:
Title
Quality of Life Scale (QLS)
Description
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.
Time Frame
Up to 15 months after the baseline appointment
Title
Revised Social Anhedonia Scale (RSAS)
Description
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.
Time Frame
Up to 15 months after the baseline appointment
Title
Beck Hopelessness Scale (BHS)
Description
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.
Time Frame
Up to 15 months after the baseline appointment
Title
Dysfunctional Attitude Scale (DAS)
Description
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).
Time Frame
Up to 15 months after the baseline appointment
Title
Road to Recovery Scale - 10 (RRS-10)
Description
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.
Time Frame
Up to 15 months after the baseline appointment
Title
Beck Self-Esteem Scale - Short Form (BSES-SF)
Description
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).
Time Frame
Up to 15 months after the baseline appointment
Title
Internalized Stigma of Mental Illness Inventory-29 (ISMI-29)
Description
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.
Time Frame
Up to 15 months after the baseline appointment
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
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.
Time Frame
Up to 15 months after the baseline appointment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Eirini Zoupou
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy

We'll reach out to this number within 24 hrs