About this trial
The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 65 years of age on the day of surgery
Scheduled major surgery with an anticipated hospital stay of 3+ days. Major operations include: orthopedic, thoracic or abdominal, cardiac procedures
Depressive symptoms - Patient Health Questionnaire (PHQ-9) screening with a score of 5+, 5-9 being subclinical depression and scores up to 27 indicating increasing depression. If the score is 5-9, we need to have at least one of these items included: "at least one of the endorsed items needs to be depressed mood or diminished activities" (questions #1 and #2)
Disqualifiers
Those with severe cognitive impairment - Short Portable Mental Status Questionnaire (SPMSQ) screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment
Unable to read, speak, and understand English
Current alcohol or other substance abuse (scoring 2+ on CAGE questionnaire or answering yes to "Do you currently use any non-prescription drugs or substances?")
Life expectancy is 6 months or less
Trial design
Parallel
Treatments tested in this trial
Problem Solving Therapy (PST)
BehavioralPST intervention in the form of one-on-one coaching in preparation for surgery and post-operative care. This coaching consists of educating and guiding the patient in developing problem-solving skills. Please refer to the PST Handbook for further detail on the therapy sessions.
Enhanced Usual Care
BehavioralParticipants in the control arm will receive "enhanced usual care". They will receive additional mental health education in the form of educational handouts mailed or emailed to them.
Treatment groups
Trial outcomes
Primary outcomes
Functional Recovery as Assessed by Score on the World Health Organization Disability Assessment Schedule (Brief-WHODAS)
6-month functional recovery is measured by a comparison of the pre- and post-operative function using self-report to the World Health Organization Disability Assessment Schedule (Brief-WHODAS). Brief-WHODAS is a 12-item questionnaire where scores assigned to each of the items \["none" (0), "mild" (1), "moderate" (2), "severe" (3), and "extreme" (4)\] are summed. The "summary score" is then converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). The rationale for using 6 months for follow-up is that after a major surgery, older adults can take up to 6 months to recover to their new functional baseline and has been used in previous studies.
Secondary outcomes
Depressive Symptoms as Assessed by Score on the by the Patient Health Questionnaire (PHQ-9)
The secondary outcome is 3 and 6-month depressive symptoms, as measured by the Patient Health Questionnaire (PHQ-9). It is a 9-item questionnaire in which each item can be scored as 0 - Not at all, 1 - Several days, 2 - More than half the days, or 3 - Nearly every day. The total score is obtained by summing the scores for each of the nine items, resulting in a total score range from 0 to 27. 0 indicates no/minimal depression, and 27 indicates severe depression.
Other outcomes
Physical pain
Brief Pain Inventory (BPI) (1 question from the 11 questions) - "Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than these everyday kinds of pain today?" Yes to indicate pain and no to indicate no pain.
Cognition
The Short Portable Mental Status Questionnaire (SPMSQ) (10-items) for assessment of cognitive function in older adults. Scoring scale of 0-8: Screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment.
Depressive symptoms
Measured by the Patient Health Questionnaire (PHQ-9), a 9-item self-report questionnaire assesses depression to gauge the severity of depression over the past two weeks. Screening with a score of 5+, 5-9 indicating subclinical depression and scores up to 27 indicating increasing depression. If the score is 5-9, at least one of these items needs to be included: "at least one of the endorsed items needs to be depressed mood or diminished activities" (questions #1 and #2).
Self-efficacy
As measured by General Perceived Self-efficacy Scale (GSE). A 10-item questionnaire with the total score being the sum of the all items. Scores range from 0-40 with a higher score indicating more self-efficacy.
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
National Institute on Aging (NIA)
Collaborator
University of California, San Francisco
Collaborator