Augmenting Hospitalization for Serious Mental Illness: Cognitive Bias Modification

NCT03509181 | Completed Results DMC

• 2 other identifiers: MH113600R34MH113600
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Bipolar Disorder; Anxiety Disorders; Psychiatric Disorder

Keywords

interpretation bias; smartphone; partial hospital

Outcome Measures

Primary Outcomes (2)

• Clinical Global Improvement Scale (CGIS)

  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

  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 Outcomes (1)

• Quality of Life Enjoyment and Satisfaction Questionnaire

  Post-treatment (1 month following discharge from hospital) (up to 8 weeks following baseline)

Study Arms (2)

CBM

EXPERIMENTAL

Cognitive Bias Modification for Interpretation delivered via smartphone

Behavioral: I-Change; Behavioral: Symptom Tracking

Symptom Tracking

ACTIVE COMPARATOR

Weekly symptom monitoring smartphone app with anxiety and depression symptom scores

Behavioral: Symptom Tracking

Interventions

I-Change BEHAVIORAL

smartphone delivered word-sentence association task that encourages a healthier interpretive style

Also known as: Cognitive Bias Modification for Interpretation

CBM

Symptom Tracking BEHAVIORAL

smartphone delivered self-monitoring of anxiety and depression symptoms

CBM; Symptom Tracking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \* current psychiatric symptoms that would prevent informed consent or understanding of research procedures (e.g., active symptoms of psychosis, mania)

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Behavioral Health Partial Hospital/McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

• Beard C, Ramadurai R, McHugh RK, Pollak JP, Bjorgvinsson T. HabitWorks: Development of a CBM-I Smartphone App to Augment and Extend Acute Treatment. Behav Ther. 2021 Mar;52(2):365-378. doi: 10.1016/j.beth.2020.04.013. Epub 2020 Apr 30.

  PMID: 33622506 DERIVED

MeSH Terms

Conditions

Depression; Bipolar Disorder; Anxiety Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders

Results Point of Contact

• Title: Courtney Beard
• Organization: McLean Hospital

cbeard@mclean.harvard.edu

617-855-3557

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 26, 2018
• Study Start: January 24, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: every 6 months

Locations

US (1)