Clinical trial NCT01768000: The Family Cognitive Adaptation Training Manual: A Test of Effectiveness
Official title: The Family CAT (Cognitive Adaptation Training Manual): A Test of Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: Psychosis
Psychosis NOS
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of family cognitive adaptation training, including its impact on functioning and caregiver burden. Families that receive the manual will be compared with a control group of families that will not receive the manual. The larger goal is to add to the tools family members have access to better support their family members with schizophrenia.

Detailed description: Efforts to address the cognitive impacts of schizophrenia can be broadly defined as falling into either compensatory or restorative categories. Restorative interventions, such as cognitive remediation, have shown promise in reducing cognitive deficits and improving functional outcomes (McGurk et al., 2007). In contrast, compensatory approaches such as Cognitive Adaptation Training work around cognitive deficits by changing the client's natural environment to support improved functioning. These compensatory strategies serve to bypass cognitive deficits and negative symptoms by organizing belongings and creating reminders and environmental cues to support specific adaptive behaviors. An example includes the individual packaging of clothes to be worn by day, to simplify the process of choosing what to wear and decrease the likelihood of clients impulsively putting on too many clothes or otherwise dressing in a manner that is not a good fit for the climate or social settings (Draper et al., 2009; Maples \& Velligan, 2008).

Cognitive Adaptation Training (CAT) is a manualized intervention that was developed to help individuals compensate for the cognitive deficits associated with schizophrenia. CAT interventions commence with a neuropsychological assessment of clients to determine the best profile of strategies to be implemented for the specific cognitive classification within which the person is placed. Interventions are based on two dimensions 1) level of executive functioning (as determined by scores on a set of neurocognitive tests) and 2) whether the behaviour of the individual is characterized more by apathy (poverty of speech and movement and difficulty initiating behaviours), disinhibition (distractibility and impulsivity) or a combination of the two. Clinicians then develop and implement an individualized set of strategies that address key domains such as hygiene, safety, dress, and medication. These strategies are then altered for strengths or weaknesses in the areas of attention, memory, and fine motor skills. For example, for someone with poor attention, the colour of signs can be changed regularly or florescent colours can be used to capture attention. For someone with memory problems (particularly those with good auditory attention) audiotapes can be used to sequence behaviour.

CAT interventions are established and maintained in the home during monthly to weekly visits from a CAT therapist/trainer with the intervention typically lasting 9 months in most of the trials that have taken place to date

Outcomes of randomized trials of CAT have been promising. Compared to control conditions, clients receiving CAT have lower levels of symptomatology, lower relapse rates, higher levels of adaptive functioning, better quality of life, and better medication adherence (Velligan et al., 2000; 2002; 2007; 2008a; 2008b). In general, CAT has been shown to be beneficial for individuals with schizophrenia who vary both in degree and type of functional impairment.

The support and involvement of family in the care of individuals with schizophrenia is both one of the most important contributors to wellness and recovery and is also, unfortunately, one of the least acknowledged components of the recovery process. A high proportion of persons with severe mental illness stay in touch with family and the involvement of family in care has been associated with better clinical outcomes, improved quality of life, and less use of hospitalization (e.g., Fischer et al., 2008). Despite evidence of the importance of family in the recovery process, the contribution of family is often not adequately appreciated by treatment providers, and contact with providers is often limited. Similarly under-developed are evidence-based tools to assist families in their efforts to support the recovery of their loved ones.

It is within this context that the development of a family member version of CAT is a very promising avenue to explore. While some elements of CAT require or are otherwise optimized by administration by a mental health professional (e.g., neuropsychological testing; targeting interventions based upon ongoing clinical evaluation), there are many standard components of CAT that can be readily implemented by a family member or other key support. Examples include CAT interventions such as visual reminders regarding medication, arranging cleaning supplies in the kitchen to reinforce cleaning routines, and assisting in the use of a calendar for scheduling. We have developed a tool that facilitates family members implementing CAT components that do not require professional administration.

The initial 'beta' version of Family CAT was developed in close collaboration between Dr. Velligan's team at the University of Texas, the group implementing CAT at the CAMH site led by Dr. Kidd, and CAMH Social Workers. This 'beta' version is currently in the process of having its content reviewed by 6 families to obtain feedback regarding how readily it can be understood. Based on this feedback, we will make edits and produce the final version to be used in the trial proposed in this protocol.

Eligibility criteria: Inclusion Criteria:

* the key family member/support is actively involved in the support of the individual with schizophrenia and regularly visits them (i.e., once a week or more frequently) in their home environment
* the individual being supported is identified (self-identified and identified by the family member) as having a primary diagnosis of schizophrenia
* the individual with schizophrenia is not in crisis or experiencing other forms of instability (e.g., imminent loss of housing) per verbal report that would threaten the implementation of the manual strategies
* proficiency in English

Exclusion criteria:

- none

Primary outcomes:
measure: Multnomah Community Ability Scale (MCAS)
timeFrame: 4 months following baseline assessment
Secondary outcomes:
measure: Brief Adherence Rating Scale (BARS)
timeFrame: 4 months following baseline assessment
measure: Satisfaction With Life Scale
timeFrame: 4 months following baseline assessment
measure: Involvement Evaluation Questionnaire (IES)
timeFrame: 4 months following baseline assessment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Sean Kidd, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alphs LD, Summerfelt A, Lann H, Muller RJ. The negative symptom assessment: a new instrument to assess negative symptoms of schizophrenia. Psychopharmacol Bull. 1989;25(2):159-63. No abstract available.
citation: Byerly MJ, Nakonezny PA, Rush AJ. The Brief Adherence Rating Scale (BARS) validated against electronic monitoring in assessing the antipsychotic medication adherence of outpatients with schizophrenia and schizoaffective disorder. Schizophr Res. 2008 Mar;100(1-3):60-9. doi: 10.1016/j.schres.2007.12.470. Epub 2008 Feb 5.
citation: Draper ML, Stutes DS, Maples NJ, Velligan DI. Cognitive adaptation training for outpatients with schizophrenia. J Clin Psychol. 2009 Aug;65(8):842-53. doi: 10.1002/jclp.20612.
citation: Fischer EP, McSweeney JC, Pyne JM, Williams DK, Naylor AJ, Blow FC, Owen RR. Influence of family involvement and substance use on sustained utilization of services for schizophrenia. Psychiatr Serv. 2008 Aug;59(8):902-8. doi: 10.1176/ps.2008.59.8.902.
citation: Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
citation: McGurk SR, Mueser KT. Cognitive functioning, symptoms, and work in supported employment: a review and heuristic model. Schizophr Res. 2004 Oct 1;70(2-3):147-73. doi: 10.1016/j.schres.2004.01.009.
citation: McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.
citation: Reichenberg A, Harvey PD. Neuropsychological impairments in schizophrenia: Integration of performance-based and brain imaging findings. Psychol Bull. 2007 Sep;133(5):833-58. doi: 10.1037/0033-2909.133.5.833.
citation: Test MA, Greenberg JS, Long JD, Brekke JS, Burke SS. Construct validity of a measure of subjective satisfaction with life of adults with serious mental illness. Psychiatr Serv. 2005 Mar;56(3):292-300. doi: 10.1176/appi.ps.56.3.292.
citation: van Wijngaarden B, Schene AH, Koeter M, Vazquez-Barquero JL, Knudsen HC, Lasalvia A, McCrone P. Caregiving in schizophrenia: development, internal consistency and reliability of the Involvement Evaluation Questionnaire--European Version. EPSILON Study 4. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000;(39):s21-7. doi: 10.1192/bjp.177.39.s21.
citation: Velligan DI, Bow-Thomas CC, Huntzinger C, Ritch J, Ledbetter N, Prihoda TJ, Miller AL. Randomized controlled trial of the use of compensatory strategies to enhance adaptive functioning in outpatients with schizophrenia. Am J Psychiatry. 2000 Aug;157(8):1317-23. doi: 10.1176/appi.ajp.157.8.1317.
citation: Velligan DI, Prihoda TJ, Ritch JL, Maples N, Bow-Thomas CC, Dassori A. A randomized single-blind pilot study of compensatory strategies in schizophrenia outpatients. Schizophr Bull. 2002;28(2):283-92. doi: 10.1093/oxfordjournals.schbul.a006938.
citation: Velligan DI, Lam F, Ereshefsky L, Miller AL. Psychopharmacology: Perspectives on medication adherence and atypical antipsychotic medications. Psychiatr Serv. 2003 May;54(5):665-7. doi: 10.1176/appi.ps.54.5.665. No abstract available.
citation: Velligan DI, Diamond PM, Mintz J, Maples N, Li X, Zeber J, Ereshefsky L, Lam YW, Castillo D, Miller AL. The use of individually tailored environmental supports to improve medication adherence and outcomes in schizophrenia. Schizophr Bull. 2008 May;34(3):483-93. doi: 10.1093/schbul/sbm111. Epub 2007 Oct 10.
citation: Velligan DI, Diamond PM, Maples NJ, Mintz J, Li X, Glahn DC, Miller AL. Comparing the efficacy of interventions that use environmental supports to improve outcomes in patients with schizophrenia. Schizophr Res. 2008 Jul;102(1-3):312-9. doi: 10.1016/j.schres.2008.02.005. Epub 2008 Apr 18.
citation: Kidd SA, Kerman N, Ernest D, Maples N, Arthur C, de Souza S, Kath J, Herman Y, Virdee G, Collins A, Velligan D. A pilot study of a family cognitive adaptation training guide for individuals with schizophrenia. Psychiatr Rehabil J. 2018 Jun;41(2):109-117. doi: 10.1037/prj0000204. Epub 2016 Aug 22.