SchizophreniaNCT05140135
Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy
A study testing Recovery Oriented Cognitive Therapy (CT-R) and Treatment as Usual in people with Schizophrenia and Schizoaffective Disorder, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Recovery Oriented Cognitive Therapy (CT-R) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients: Medical comorbidities causing brain damage (e.g., stroke, dementia), significant suicidal risk/ideation requiring immediate referral or suicidal gesture.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Recovery Oriented Cognitive Therapy (CT-R), Treatment as Usual
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Oriented Cognitive Therapy (CT-R)Behavioural
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.
Treatment as UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Recovery Oriented Cognitive Therapy (CT-R) |
| Continued Usual Care | Active comparator | Not described Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 15 months after the baseline appointment
Secondary outcomes (8)
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.
Measured: Up to 15 months after the baseline appointment
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.
Measured: Up to 15 months after the baseline appointment
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.
Measured: Up to 15 months after the baseline appointment
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).
Measured: Up to 15 months after the baseline appointment
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.
Measured: Up to 15 months after the baseline appointment
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).
Measured: Up to 15 months after the baseline appointment
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.
Measured: Up to 15 months after the baseline appointment
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.
Measured: Up to 15 months after the baseline appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start11 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: The funds used to originally support the study were withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140135
- Sponsor's protocol ID
- 844100
- Status last verified
- May 2022
- First submitted
- 17 Nov 2021
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy
- ClinicalTrials.gov ID
- NCT05140135
- Acronym / sponsor ID
- 844100
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The funds used to originally support the study were withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Oriented Cognitive Therapy (CT-R) | Experimental | Behavioral: Recovery Oriented Cognitive Therapy (CT-R)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. |
| Continued Usual Care | Active comparator | Other: Treatment as Usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients: Medical comorbidities causing brain damage (e.g., stroke, dementia), significant suicidal risk/ideation requiring immediate referral or suicidal gesture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Recovery Oriented Cognitive Therapy (CT-R) |
| Treatment as UsualAll 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. | Other | Continued Usual Care |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: Up to 15 months after the baseline appointment
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).
8 secondary outcomes
Quality of Life Scale (QLS)
Time frame: Up to 15 months after the baseline appointment
Revised Social Anhedonia Scale (RSAS)
Time frame: Up to 15 months after the baseline appointment
Beck Hopelessness Scale (BHS)
Time frame: Up to 15 months after the baseline appointment
Dysfunctional Attitude Scale (DAS)
Time frame: Up to 15 months after the baseline appointment
Road to Recovery Scale - 10 (RRS-10)
Time frame: Up to 15 months after the baseline appointment
Beck Self-Esteem Scale - Short Form (BSES-SF)
Time frame: Up to 15 months after the baseline appointment
Internalized Stigma of Mental Illness Inventory-29 (ISMI-29)
Time frame: Up to 15 months after the baseline appointment
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Up to 15 months after the baseline appointment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Oriented Cognitive Therapy (CT-R) and Treatment as Usual in people with Schizophrenia and Schizoaffective Disorder, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: Up to 15 months after the baseline appointment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.