Thinking Skills at Work: Cognitive Remediation Therapy for Patients With Serious Mental Illness
Condition: Schizophrenia and Related Disorders; Psychotic Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to help people with serious mental illness get and keep the job
      they want by improving their thinking skills, using cognitive remediation therapy. For people
      with serious mental illness, the Individual Placement and Support (IPS) Program is an
      effective approach to help people become employed. Despite its general success, still only
      55% of clients find employment. Most of that success occurs in the first three months; after
      six months, the chances of finding competitive work are quite low. Among those who fail to
      find employment with IPS, cognitive dysfunction is often a significant problem. The proposed
      study will target IPS clients who have not found work after 3 months of employment-support
      services: our hypothesis is that, after three months with no success, the addition of
      cognitive remediation to IPS will improve employment rates (compared to those who continue to
      receive IPS alone).

      The proposed randomized controlled trial will use a single-blind study design, focused on IPS
      clients who are slow to (or may never) find employment success. Specifically, the proposed
      study will have two treatment arms: a) cognitive remediation added to continued IPS services,
      and b) continued IPS services alone. The study will collaborate with IPS workers at 11 Mental
      Health and Substance Use (MHSU) clinics to identify clients who are non-responders in the
      first 3 months, and seek their consent to participate in the study. They will be randomized
      to either TAU (continuation with IPS and other standard treatments), or TAU plus cognitive
      remediation. The CRT will consist of computerized cognitive exercise practice, strategy
      coaching, and teaching coping/compensatory strategies for 12 weeks. Clients will be assessed
      at 3-time points: prior to the start of cognitive remediation ("baseline"), end-point
      (3-month), and 6 months after the endpoint evaluation. Primary outcome measures will include
      success at gaining a competitive job, total hours of competitive employment, and
      neuropsychological measures of cognition.
    

Detailed description: 
      Background Information:

      The Individual Placement and Support (IPS) program is an evidence-based vocational
      rehabilitation services that assist individuals with mental illness or significant mental
      health concerns gain and maintain competitive employment in the community. Unemployment rates
      among people with mental illness are high, even though most people with serious mental
      illness want to work.

      Fraser Health provides IPS services to approximately 350 MHSU clients per year in six
      communities. The IPS strategy helps about 55% of clients find competitive jobs, but almost
      half (45%) fail to find work. Among those who fail to find employment, cognitive dysfunction
      is often a significant problem.

      Cognitive remediation therapy (CRT) is an evidence-based, psychological treatment for the
      neurocognitive deficits seen in patients with severe mental illness. CRT targets cognitive
      functioning with the goal of improving role functioning in daily life. When compared with
      employment intervention alone, programs that incorporate CRT have shown a variety of
      vocational benefits, (e.g., more likely to work, held more jobs, worked more weeks, and
      earned more in wages) that are maintained even at a 3-year follow-up. CRT targeted to clients
      who have not been successful with IPS is efficient: non-responders improved employment
      outcome with a number needed-to-treat (NNT) of 4 over a two-year period.

      Cognitive remediation (CRT) improves thinking skills and work functioning. CRT provides
      specific training modules and exercises that target thinking skills known to be impaired in
      severe mental illness. For example, working memory and cognitive flexibility are trained
      through real-world exercises that teach clients to organize and manage time, focus their
      attention, consider errors and their consequences, control answers and plan ahead. These
      skills are important to be successful in obtaining and maintaining employment.

      Purpose of Study:

      The primary purpose of this study is to assess, for people with serious mental illness who
      have failed to find employment despite three months of support in the IPS program, the
      effects of 12 weeks of cognitive remediation therapy (CRT) on subsequent employment outcomes
      while they continue to receive IPS employment-support services. Hypothesis:

      The first hypothesis is that adding CRT for those who have not found employment by 3 months
      in the program will result in better competitive work outcomes, compared to those who
      continue IPS alone. The second hypothesis is that participants receiving CRT will improve
      more in cognitive functioning than those who did not receive CRT training. The third
      hypothesis is that symptom severity will be related to work outcomes.
    

Intervention name(s): Cognitive Remediation Therapy
Intervention type(s): Behavioral
Intervention description(s): The intervention of interest for participants in the experimental group is the addition of up to 5 hours per week of computerized cognitive exercises. Cognitive training can be done at home on a computer. For participants without access to a computer, a laptop/tablet computer with the necessary software will be provided for the duration of training. Participants will be able to complete the cognitive exercises on their own schedule, with participation verified by the software. Participants will also receive 1 hour/week of individual coaching to discuss cognitive remediation progress, e.g. to learn about different cognitive domains and develop ways to generalize their cognitive remediation gains.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Remediation Therapy