Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM) (CAT-EM)
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|ClinicalTrials.gov Identifier: NCT03829280|
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Behavioral: Cognitive Adaptation Training Behavioral: Community Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the country|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Raters assessing clinical outcome variables are centralized raters who are blind to treatment group as well as study design and aims.|
|Official Title:||Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)|
|Actual Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: Cognitive Adaptation Training
Psychosocial treatment using environmental supports such as signs, alarms, pill containers, checklists, technology and the organization of belongings established in a person's home or work environment to bypass the cognitive and motivational difficulties associated with schizophrenia, and support habits for functional behavior to promote recovery.
Behavioral: Cognitive Adaptation Training
Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
Other Name: CAT
Active Comparator: Community Treatment
Medication follow-up and case management as provided by the community mental health center according to usual care.
Behavioral: Community Treatment
Medication follow-up and case management as provided in usual community care in the setting
Other Name: CT
- Change in Social and Occupational Functioning Scale Scores [ Time Frame: baseline, 6 months, 12 months ]A rating from 0-100 reflecting global level of Social and Occupational functioning; Higher scores indicate better functioning.
- Change in Daily activity [ Time Frame: baseline, 6 months, 12 months ]Negative Symptom Assessment item 14 assessing typical daily behavior using a structured interview with behavioral anchor points. Scale is rated 1 to 6 with higher scores indicating lower levels of engagement in daily activity (i.e. more severe apathy)
- Change in Multnomah Community Ability Scale mean score [ Time Frame: baseline, 6 months, 12 months ]Assessment of community functioning on a 17 -item scale with domains assessing interference with functioning, adjustment to living, social competence and behavioral problems. Items are averaged to produce a mean score. Items are each rated on a scale from 1-5 with higher scores reflecting better community functioning.
- Change in Adherence Estimate Score [ Time Frame: baseline, 6 months, 12 months ]A 3 item scale assessing variables associated with adherence. Items are rated based upon self report about the importance of taking medication, worry about medication and financial burden of medication on a scale from agree completely to disagree completely. Each answer is assigned points based on an algorithm and added producing a total score. Higher scores indicate a higher risk for adherence and a lower probability of adherence. Scores range for 0 to 100.
- Change in Negative Symptom Assessment-16 Mean Score [ Time Frame: baseline, 6 months, 12 months ]Assesses 16 negative symptoms in the domains of communication, emotion/affect, social activity, motivation and psychomotor activity on a scale from 1-6. Items are added and divided by 16 to produce a mean score. A global score is also produced based upon clinical judgement following the interview Higher scores reflect higher levels of negative symptoms.
- Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score [ Time Frame: baseline, 6 months, 12 months ]24 item scale assessing multiple dimensions of psychopathology including positive symptoms; negative symptoms, anxiety/depression, and activation on a series of 7 point scales. Higher scores reflect higher levels of symptoms.
- Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score [ Time Frame: baseline, 6 months, 12 months ]computerized task of effort put forth to win various amounts of money under various levels of probability. The probability difference score equals the percent of hard choices in the high probability condition minus the percent of hard choices in the low probability condition. Higher scores indicate more frequent choices of hard tasks at the high versus low probability level. individuals who answer the same way on all tasks are eliminated (estimate 1%)
- Change in global score of Brief Assessment of Cognition (BACS) App [ Time Frame: baseline, 6 months, 12 months ]Ipad delivered version of BACS assessing memory, attention, executive function and psychomotor speed. Standard scores are generated and summed to create a global cognition score with higher scores indicating better levels of cognitive function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829280
|Contact: Dawn I Velligan, PhDemail@example.com|
|Contact: Marina S Robertson, LPCfirstname.lastname@example.org|
|United States, Connecticut|
|United Services Inc.||Recruiting|
|Dayville, Connecticut, United States, 06241|
|Contact: Sandy Long email@example.com|
|United States, Florida|
|Henderson Behavioral Health||Recruiting|
|Lauderdale Lakes, Florida, United States, 33319|
|Contact: Elise Ward firstname.lastname@example.org|
|United States, Illinois|
|Chestnut Health Systems||Recruiting|
|Granite City, Illinois, United States, 62040|
|Contact: Jamie Jung email@example.com|
|United States, Indiana|
|Community Mental Health Center Inc.||Recruiting|
|Lawrenceburg, Indiana, United States, 47025|
|Contact: Bill Hardy firstname.lastname@example.org|
|United States, New Hampshire|
|Mental Health Center of Greater Manchester||Recruiting|
|Manchester, New Hampshire, United States, 03101|
|Contact: Sue Guarino email@example.com|
|United States, Oregon|
|Eugene, Oregon, United States, 97401|
|Contact: Coleen Hudkins CHudkins@peacehealth.org|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02904|
|Contact: Tara Zorabedian firstname.lastname@example.org|
|United States, Texas|
|The Harris Center for Mental Health & IDD||Not yet recruiting|
|Houston, Texas, United States, 77074|
|Contact: Scott Hickey Scott.Hickey@TheHarrisCenter.org|
|Principal Investigator:||Dawn Velligan, PhD||University of Texas|