Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03509181 |
| Other study ID # |
MH113600 |
| Secondary ID |
R34MH113600 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 24, 2019 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
February 2024 |
| Source |
Mclean Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Approximately 4.1% of the adult US population meets the criteria for SMI, a mental disorder
associated with significant functional impairment. Even when effective, pharmacologic and
psychological treatments often leave individuals with SMI with residual symptoms, impairment,
and at risk for re-hospitalization and suicide. The month following hospitalization is a
particularly risky time; thus, augmentation treatments that can speed up improvement during
brief hospital stays, as well as provide a bridge to outpatient care are urgently needed.
Thus, the investigators propose to develop an augmentation to psychiatric hospital care
(called "I-Change") that can be continued at home following discharge. I-Change targets
interpretation bias, the tendency to resolve ambiguous situations negatively. Interpretation
bias is a well-established cognitive vulnerability for psychopathology and is associated with
poor emotion regulation, rumination, symptom severity, and suicidal ideation. For example, in
a psychiatric hospital sample, interpretation bias upon admission accounted for 28% of the
variance in treatment response, and predicted suicidal ideation at discharge, controlling for
ideation at admission. Although some existing treatments target this mechanism, most notably
Cognitive Behavioral Therapy (CBT), they require individuals to be able to recognize their
automatic interpretations and use complex techniques to reappraise them. Individuals with SMI
who are experiencing symptoms acute enough to require hospitalization are often treatment
refractory and may experience particular difficulty applying these techniques. It is
therefore critical to more efficiently and effectively engage this target. Over the past 14
years, the Principal Investigator has developed and validated a training task that utilizes
repetition and feedback to reinforce a healthier interpretive style. The computer-delivered
version of the task was acceptable to an SMI population and led to better treatment response
than a placebo task in patients who exhibited interpretation bias at baseline. The
investigators seek to develop this task into a personalized smart-phone delivered
intervention. The investigators will harness smart-phone technology to enhance skill
acquisition and generalization by improving user engagement and prompting participants to
complete a session at set times to ensure adequate dosage and spacing of sessions. The
investigators will conduct an open trial (n = 16) and a randomized controlled trial (n = 64)
to confirm target engagement (improvement in interpretation bias), evaluate the feasibility
and acceptability of delivering I-Change during and following discharge from a partial
hospital, and examine clinical outcomes (global improvement, functioning) related to changes
in interpretation. I-Change is expected to shift interpretation bias, be acceptable to
patients with SMI, and lead to greater global improvement compared to a Symptom Tracking
control. Results will support a fully-powered effectiveness trial.
Description:
Treatment in acute psychiatric hospital settings is brief, and many individuals continue to
experience residual symptoms and impairment upon discharge. The months following discharge
from hospitalization are particularly risky, as individuals transition from a highly
structured and supportive environment to home, acute stressors, and uncertain aftercare.
Currently, there are few interventions available to accelerate improvement during brief
hospital stays, or to provide a bridge to outpatient care. Thus, there is an urgent need to
develop augmentations to hospital care that both more efficiently reduce symptoms during the
acute hospital stay and provide continuation of care during the transition to home. Such new
interventions are critical to reduce the risk of relapse, re-hospitalization, and suicide in
individuals with Serious Mental Illness (SMI).
The long-term goal of this study is to develop effective and scalable interventions that
target key mechanisms in psychopathology and are easily implemented in real world settings.
The overall objective of this study is to develop a low-intensity augmentation to psychiatric
partial hospital care that can be continued during the transition to home. "I-Change", a
personalized, smart-phone delivered cognitive bias modification (CBM) treatment, is expected
to hasten improvement in pathological cognitive processes and clinical outcomes during
hospitalization and following discharge compared to a control. This hypothesis is based on
the principal investigator's (PI) 14 years of research developing and testing CBM treatments,
including a pilot study of 65 patients attending a partial hospital program that showed
excellent feasibility, acceptability, large effects on cognitive bias, and moderate effects
on clinical outcomes compared to a placebo control.
I-Change will target the maladaptive interpretative style that maintains emotional disorders.
The way in which individuals automatically resolve the countless ambiguous situations
encountered each day has a large impact on their affect and behavior. Interpretation bias,
the tendency to resolve such ambiguity negatively, is a crucial therapeutic target because it
is associated with poor emotion regulation, rumination, symptom severity, suicidal ideation,
and treatment response. Although existing treatments target interpretation bias, most notably
Cognitive Behavioral Therapy (CBT), they require individuals to recognize their automatic
interpretations and use complex techniques to reappraise them. Individuals experiencing
symptoms sufficiently acute to require hospital care often experience difficulty applying
these techniques. In contrast, the PI validated a computerized training task that utilizes
quick, repeated practice and feedback to more efficiently reinforce a healthier interpretive
style. Ten studies demonstrate that the task engages interpretation bias and leads to
improved clinical outcomes in individuals with mood and anxiety disorders, including a
psychiatric hospital sample. The CBM task is highly acceptable and uniquely suited to acute
psychiatric settings due to its low complexity and engaging qualities.
Specific Aim 1: Develop a smart-phone delivered intervention to augment hospital care.
This study will harness smart-phone technology to enhance the acquisition of a healthier
interpretive style by personalizing the situations presented, prompting participants to
complete sessions to ensure adequate dosage, and incorporating features to enhance adherence.
Delivery via smart phone increases accessibility of the intervention by overcoming barriers
(e.g., transportation, computer access) within the hospital and at home and allows better
assessment of outcomes in "real time" via ecological momentary assessment. An Advisory Board
of patients, hospital providers, experts in CBM and mobile health technology, and other
stakeholders (i.e., directors of acute psychiatric clinics) will inform the development of
I-Change.
Specific Aim 2: Obtain pilot data to support a fully-powered randomized controlled trial
(RCT), including measures of (a) target engagement (improvement in interpretation bias), (b)
feasibility and acceptability of I-Change and procedures for hospital and home delivery, and
(c) global improvement and functioning Participants will complete I-Change daily while
admitted to the partial hospital and three times per week at home during the 1-month
following discharge. Consistent with a precision medicine and RDoC approach, participants
will be selected based on baseline level of interpretation bias (not diagnosis). The
investigators will first conduct an open trial of I-Change (n = 16) to inform refinements.
The investigators will conduct a pilot RCT (n = 64) to obtain data to inform the design of a
future trial. Participants will be randomly assigned to I-Change or a Symptom Tracking
control and assessed at admission, discharge, 1-month and 3-months following discharge.
Obtained data will be compared to a priori benchmarks of feasibility, acceptability, target
engagement, and clinical improvement.
The final products of this study will be the I-Change app, RCT protocol, and pilot data to
support a future confirmatory effectiveness trial. Achievement of these aims will result in a
simple, scalable augmentation to psychiatric partial hospital care that can improve outcomes
following hospital care.
