Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy

Sponsor
University of Pennsylvania (Other)
Overall Status
Withdrawn
CT.gov ID
NCT05140135
Collaborator
(none)
0
1
2
59.6
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Recovery Oriented Cognitive Therapy (CT-R)
  • Other: Treatment as Usual
N/A

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

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness and Mechanisms of Recovery Oriented Cognitive Therapy
Actual Study Start Date :
Jan 11, 2021
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Active Comparator: Continued Usual Care

Other: Treatment as Usual
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.

Outcome Measures

Primary Outcome Measures

  1. Positive and Negative Syndrome Scale (PANSS) [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).

Secondary Outcome Measures

  1. Quality of Life Scale (QLS) [Up to 15 months after the baseline appointment]

    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.

  2. Revised Social Anhedonia Scale (RSAS) [Up to 15 months after the baseline appointment]

    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.

  3. Beck Hopelessness Scale (BHS) [Up to 15 months after the baseline appointment]

    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.

  4. Dysfunctional Attitude Scale (DAS) [Up to 15 months after the baseline appointment]

    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).

  5. Road to Recovery Scale - 10 (RRS-10) [Up to 15 months after the baseline appointment]

    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.

  6. Beck Self-Esteem Scale - Short Form (BSES-SF) [Up to 15 months after the baseline appointment]

    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).

  7. Internalized Stigma of Mental Illness Inventory-29 (ISMI-29) [Up to 15 months after the baseline appointment]

    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.

  8. Connor-Davidson Resilience Scale (CD-RISC) [Up to 15 months after the baseline appointment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eirini Zoupou Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05140135
Other Study ID Numbers:
  • 844100
First Posted:
Dec 1, 2021
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022