Behavioral Activation and Medication Optimization for Perioperative Mental Health

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05110690
Collaborator
National Institute of Mental Health (NIMH) (NIH)
100
Enrollment
1
Location
3
Arms
28.4
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Inadequate management of preoperative mental health disorders often contributes to poor postoperative outcomes, including increased rates of readmission, delirium, falls, and mortality. However, very little work has been done to improve perioperative mental health. In particular, there has been limited systematic efforts that identify evidence-based behavioral and pharmacological strategies that were originally developed for depression and anxiety in otherwise medically well psychiatric patients. A mental health intervention bundle, composed of behavioral and pharmacological strategies, can mitigate anxiety and depression symptoms during the perioperative period. However, lacking is conclusive evidence on effectiveness of such an intervention bundle focused on the delivery of perioperative mental health care in older surgical patients. Towards this end, the investigators will develop and test an intervention bundle that encompasses: (1) behavioral activation, and (2) medication optimization.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Behavioral Activation
  • Other: Medication Optimization
N/A

Detailed Description

The proposed research is relevant to public health because the prevalence of undertreated depression/anxiety in older adults coupled with the increasing number of surgeries performed in this population are creating a crucial need for the integration of mental health interventions into critical periods, such as the perioperative period. Thus, the proposed research is relevant to the mission of the NIMH to transform the treatment of mental illnesses through clinical research, paving the way for prevention, recovery, and cure.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study
Actual Study Start Date :
Nov 17, 2021
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Patient Participants

Behavioral activation (BA) will span across 3 months postoperatively & will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference & health condition. Medications will be reviewed & optimized by a team of interventionists including a psychiatrist, pharmacologist, & pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house & that no new inappropriate medications are initiated. After discharge, & up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.

Behavioral: Behavioral Activation
The behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values

Other: Medication Optimization
Medication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment.

No Intervention: Caregiver Participants

-Caregivers will be invited to participate in semi-structured interviews about the intervention bundle that can be conducted via Zoom/phone or in-person depending on participant choice.

No Intervention: Clinician participants

-Clinicians will be invited to participate in semi-structured interviews about the intervention bundle that can be conducted via Zoom/phone or in-person depending on participant choice.

Outcome Measures

Primary Outcome Measures

  1. Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) [Baseline, 1 month, and 3 months after surgery]

    9 item questionnaire with answers ranging from 0=not at all to 3=nearly every day. Scores represent: 0-5=mild, 6-10=moderate, 11-15=moderately severe, and 16-20=severe depression.

  2. Change in anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) [Baseline, 1 month, and 3 months after surgery]

    7 item questionnaire with answers ranging from 0=not at all to 3=nearly every day. Total score for the seven items ranges from 0 to 21. Scores 0-5=mild anxiety, 6-10=moderate anxiety, 11-15=moderately severe anxiety, and 15-21=severe anxiety.

  3. Change in anxiety and depression target engagement as measured by the Behavioral Activation for Depression Scale (BADS) [Baseline, 1 month, 2 months, and 3 months after surgery]

    9 item questionnaire with answers ranging from 0=not at all to 6=completely. The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. For the total scale, higher scores represent increased activation, while for the Social Impairment subscale, higher scores represent increased social impairment.

Secondary Outcome Measures

  1. Change in quality of life as measured by the Veterans RAND 12 Item Health Survey (VR-12) [Baseline, 1 month, and 3 months after surgery]

    A patient-reported global health measure. The questions in this survey correspond to the QOL domains of general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Scoring is done by algorithm calculating percentiles based on US norms.

  2. Incidence of in-hospital delirium [During post-operative hospital stay (estimated average to be 12 days)]

  3. Number of post-discharge falls [Baseline, 1 month, 2 months, and 3 months after surgery]

    -A Patent Reported Falls survey will be collected monthly either by phone or REDCap link, at follow-up clinic appointments.

  4. Length of hospital stay [During post-operative hospital stay (estimated average to be 12 days)]

    -Includes both hospital and ICU

  5. Number of all-cause rehospitalizations [At 1 month and 3 months after surgery]

  6. Patient experience as measured by the Modified Consumer Assessment of Healthcare Providers and Systems (CAHPS) [Post-end of study (estimated to be 2 weeks after 3 month end of study visit)]

    -The modified CAHPS asks patients about their experience before surgery, during surgery, and after surgery.

  7. Shared decision making as measured by the Shared Decision Making Process CollaboRATE modified [Post-end of study (estimated to be 2 weeks after 3 month end of study visit)]

    A 3-item survey modified to measure shared decision making, following a encounters with study interventionists and perioperative wellness partners. Scale is from 0=no effort was made to 9=every effort was made.

  8. Acceptability of intervention measure (AIM) [Post-end of study (estimated to be 2 weeks after 3 month end of study visit)]

    -8 statements with a scale from 1=completely disagree to 5=completely agree. The higher the score the more acceptable the patients found the intervention measure.

  9. Intervention Appropriateness Measure (IAM) [Post-end of study (estimated to be 2 weeks after 3 month end of study visit)]

    -8 statements with a scale from 1=completely disagree to 5=completely agree. The higher the score the more appropriate the patients found the intervention measure.

  10. Feasibility of Intervention Measure (FIM) [Post-end of study (estimated to be 2 weeks after 3 month end of study visit)]

    -8 statements with a scale from 1=completely disagree to 5=completely agree. The higher the score the more feasible the patients found the intervention measure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria Patient Participants

  • Age ≥65 years on the day of surgery;

  • Scheduled major orthopedic surgery, or major surgical resection of a thoracic or abdominal malignancy, or major cardiac procedure;

  • Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10

Exclusion Criteria Patient Participants

  • Estimated life expectancy < 12 months;

  • Unable to read, speak, and understand English;

  • Current alcohol or other substance abuse;

  • Severe cognitive impairment screened by the SBT (Short Blessed Test) >10;

  • Acutely suicidal

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Washington University School of MedicineSaint LouisMissouriUnited States63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Michael Avidan, MBBCh, FCASA, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05110690
Other Study ID Numbers:
  • 202101103
  • 1P50MH122351
First Posted:
Nov 8, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021