An interventional study of Family Cognitive Adaptation Training in Psychosis, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2016-03-01.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
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.
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.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
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Exclusion criteria:
Participants in this group will receive the Family CAT manual and DVD
Behavioral: Family Cognitive Adaptation Training
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
Also known as: Family CAT
Multnomah Community Ability Scale (MCAS)
The Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.
Time frame: 4 months following baseline assessment
Brief Adherence Rating Scale (BARS)
The Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.
Time frame: 4 months following baseline assessment
Satisfaction With Life Scale
8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.
Time frame: 4 months following baseline assessment
Involvement Evaluation Questionnaire (IES)
The 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.
Time frame: 4 months following baseline assessment
Recruited between March 2013 and February 2014 in Ontario, Canada.
| Milestone | Family Cognitive Adaptation Training - Caregivers | Control Group - Caregivers | Family Cognitive Adaptation Training - Family Members | Control Group - Family Members |
|---|---|---|---|---|
| Started | 10 | 10 | 10 | 10 |
| Completed | 9 | 8 | 9 | 8 |
| Not completed | 1 | 2 | 1 | 2 |
The Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.
| units on a scale | Family Cognitive Adaptation Training - Caregivers | Control Group - Caregivers | Family Cognitive Adaptation Training - Family Members | Control Group - Family Members |
|---|---|---|---|---|
| Total | 67.78 ± 5.70 | 74.63 ± 5.45 | 70.00 ± 5.10 | 74.38 ± 5.15 |
| Health | 21.67 ± 2.34 | 22.13 ± 2.36 | 21.56 ± 1.88 | 21.50 ± 1.93 |
| Adaptation | 10.89 ± 2.57 | 13.25 ± 1.67 | 11.78 ± 1.92 | 13.00 ± 1.69 |
| Social Skills | 17.44 ± 3.17 | 20.63 ± 2.50 | 18.33 ± 3.87 | 20.75 ± 2.71 |
| Behaviour | 17.78 ± 1.72 | 18.63 ± 1.77 | 18.33 ± 1.80 | 19.13 ± 1.36 |
The Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.
| units on a scale | Family Cognitive Adaptation Training - Caregivers | Control Group - Caregivers | Family Cognitive Adaptation Training - Family Members | Control Group - Family Members |
|---|---|---|---|---|
| Brief Adherence Rating Scale (BARS) | 77.22 ± 35.98 | 87.50 ± 35.36 | 59.33 ± 44.03 | 88.75 ± 31.82 |
8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.
| units on a scale | Family Cognitive Adaptation Training - Family Members | Control Group - Family Members |
|---|---|---|
| Social Relationships | 2.06 ± 0.92 | 2.18 ± 0.73 |
| Employment/Work | 1.63 ± 1.16 | 2.17 ± 0.41 |
| Social & Present Life | 2.00 ± 0.99 | 2.29 ± 0.76 |
| Living Situation | 3.11 ± 0.49 | 3.00 ± 0.66 |
The 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.
| units on a scale | Family Cognitive Adaptation Training - Caregivers | Control Group - Caregivers |
|---|---|---|
| Total | 57.72 ± 9.66 | 49.25 ± 11.15 |
| Tension | 15.50 ± 4.27 | 14.13 ± 2.85 |
| Supervision | 8.22 ± 2.05 | 7.50 ± 1.07 |
| Worrying | 17.89 ± 4.31 | 15.25 ± 4.40 |
| Urging | 20.56 ± 7.13 | 16.38 ± 5.66 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Family Cognitive Adaptation Training - Caregivers | — | 0/10 (0%) | 0/10 (0%) |
| Control Group - Caregivers | — | 0/10 (0%) | 0/10 (0%) |
| Family Cognitive Adaptation Training - Family Members | — | 0/10 (0%) | 0/10 (0%) |
| Control Group - Family Members | — | 0/10 (0%) | 0/10 (0%) |
Baseline Analysis includes all participants recruited into the study that completed the entire baseline assessment.
| Age, Categorical(Participants) | Family Cognitive Adaptation Training - Family Members | Family Cognitive Adaptation Training - Caregivers | Control Group - Family Members | Control Group - Caregivers | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 9 | 9 | 8 | 36 |
| >=65 years | 0 | 1 | 0 | 1 | 2 |
| Sex: Female, Male(Participants) | Family Cognitive Adaptation Training - Family Members | Family Cognitive Adaptation Training - Caregivers | Control Group - Family Members | Control Group - Caregivers | Total |
|---|---|---|---|---|---|
| Female | 2 | 7 | 4 | 6 | 19 |
| Male | 8 | 3 | 5 | 3 | 19 |
| Race/Ethnicity, Customized(participants) | Family Cognitive Adaptation Training - Family Members | Family Cognitive Adaptation Training - Caregivers | Control Group - Family Members | Control Group - Caregivers | Total |
|---|---|---|---|---|---|
| Asian East | 1 | 1 | 0 | 0 | 2 |
| Asian South | 1 | 3 | 1 | 0 | 5 |
| Asian South East | 1 | 0 | 0 | 0 | 1 |
| Black Canadian | 1 | 0 | 1 | 1 | 3 |
| Latin American | 0 | 1 | 0 | 0 | 1 |
| White Canadian | 5 | 5 | 5 | 3 | 18 |
| White European | 0 | 0 | 1 | 3 | 4 |
| Other | 0 | 0 | 0 | 1 | 1 |
| Asian (not specified) | 0 | 0 | 1 | 1 | 2 |
| Not specified | 1 | 0 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Family Cognitive Adaptation Training - Family Members | Family Cognitive Adaptation Training - Caregivers | Control Group - Family Members | Control Group - Caregivers | Total |
|---|---|---|---|---|---|
| Canada | 10 | 10 | 9 | 9 | 38 |
| Employment status(participants) | Family Cognitive Adaptation Training - Family Members | Family Cognitive Adaptation Training - Caregivers | Control Group - Family Members | Control Group - Caregivers | Total |
|---|---|---|---|---|---|
| Full-time | 1 | 4 | 1 | 4 | 10 |
| Part-time | 1 | 2 | 1 | 3 | 7 |
| In school | 3 | 0 | 1 | 0 | 4 |
| Unemployed | 5 | 1 | 5 | 1 | 12 |
| Retired | 0 | 0 | 1 | 0 | 1 |
| Contract work | 0 | 3 | 0 | 0 | 3 |
| Not specified | 0 | 0 | 0 | 1 | 1 |
| Level of education(participants) | Family Cognitive Adaptation Training - Family Members | Family Cognitive Adaptation Training - Caregivers | Control Group - Family Members | Control Group - Caregivers | Total |
|---|---|---|---|---|---|
| Completion of graduate school | 0 | 2 | 0 | 2 | 4 |
| Completion of undergraduate university/college | 0 | 5 | 2 | 4 | 11 |
| Partial undergraduate university/college | 7 | 2 | 5 | 0 | 14 |
| Completion of high school | 1 | 1 | 1 | 2 | 5 |
| Partial high school | 1 | 0 | 1 | 0 | 2 |
| Not specified | 1 | 0 | 0 | 1 | 2 |
| Housing(Participants) | Family Cognitive Adaptation Training - Family Members | Family Cognitive Adaptation Training - Caregivers | Control Group - Family Members | Control Group - Caregivers | Total |
|---|---|---|---|---|---|
| Own/rent apartment or home | 0 | NA | 2 | NA | NA |
| Supported housing | 1 | NA | 1 | NA | NA |
| Live with family | 9 | NA | 6 | NA | NA |
Plan to share: No
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