- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509181
Augmenting Hospitalization for Serious Mental Illness: Cognitive Bias Modification
Augmenting Hospitalization for Serious Mental Illness by Targeting Interpretation Bias
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Belmont, Massachusetts, United States, 02478
- Behavioral Health Partial Hospital/McLean Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- currently receiving partial hospital care at the study site
- age ≥18
- at least moderate symptom severity (PHQ-9 or GAD-7 score > 10)
- signing a release of information for treatment providers
- a minimal level of interpretation bias (<80% accuracy on the Word Sentence Association Paradigm)
Exclusion Criteria:
* current psychiatric symptoms that would prevent informed consent or understanding of research procedures (e.g., active symptoms of psychosis, mania)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBM
Cognitive Bias Modification for Interpretation delivered via smartphone
|
smartphone delivered word-sentence association task that encourages a healthier interpretive style
Other Names:
smartphone delivered self-monitoring of anxiety and depression symptoms
|
Active Comparator: Symptom Tracking
Weekly symptom monitoring smartphone app with anxiety and depression symptom scores
|
smartphone delivered self-monitoring of anxiety and depression symptoms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Global Improvement Scale (CGIS)
Time Frame: Post-treatment (1 month following discharge from hospital) (up to 8 weeks following baseline)
|
Self-reported improvement rating.
Outcome is number of participants who reported feeling much or very much improved.
|
Post-treatment (1 month following discharge from hospital) (up to 8 weeks following baseline)
|
5-item Work and Social Adjustment Scale
Time Frame: Post-treatment (1 month following discharge from hospital)(up to 8 weeks following baseline)
|
The Work and Social Adjustment Scale assesses interference caused by the patient's symptoms in the domains of work, home management, leisure, and family relationships.
It includes 5 items each rated from 0 to 8 with total scores ranging from 0 to 40 and higher scores indicating more impairment.
|
Post-treatment (1 month following discharge from hospital)(up to 8 weeks following baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Enjoyment and Satisfaction Questionnaire
Time Frame: Post-treatment (1 month following discharge from hospital) (up to 8 weeks following baseline)
|
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) is a 16 item questionnaire that asks about life satisfaction over the past week.
Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good).
Scores from the individual items are added together and reported as percentage maximum possible score.
The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score.
(Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score).
Higher scores indicate better quality of life.
|
Post-treatment (1 month following discharge from hospital) (up to 8 weeks following baseline)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH113600
- R34MH113600 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Lawson Health Research InstituteTerminated
Clinical Trials on I-Change
-
University of California, BerkeleyEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedSleep Deprivation | Adolescent BehaviorUnited States
-
Chulalongkorn UniversityUnknown
-
Ludwig-Maximilians - University of MunichChild Health Foundation; Johnson & Johnson Citizenship Trust, in cooperation... and other collaboratorsCompleted
-
Children's Hospital of Fudan UniversityXiamen Children's Hospital; Shenzhen Children's Hospital; Anhui Province Children...CompletedBacterial InfectionsChina
-
Scripps Center for Integrative MedicineUnknown
-
Queen's University, BelfastUniversity of Warwick; University of BirminghamCompletedChild BehaviorUnited Kingdom
-
Georgia State UniversityArizona State UniversityEnrolling by invitationAlcohol Drinking | Sexual AssaultUnited States
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Universitat de VicActive, not recruitingConstipation Chronic IdiopathicSpain
-
University of AberdeenUniversity of JazanActive, not recruiting
-
University of BradfordCompleted