Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Depressive Disorder

Depression

Psychotropic Drugs

All Drugs and Chemicals

Fluoxetine

* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively.
* 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.

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

Behavioral Activation

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.

Medication Optimization

Benjamin D Kozower, M.D., MPH

Simon Haroutounian, Ph.D., MSc

Kenneth Freedland, Ph.D.

Michael Avidan, MBBCh

Eric Lenze, M.D.

Joanna Abraham, Ph.D.

Katherine Holzer, Ph.D.

Thomas Kannampallil, Ph.D.

J. Philip Miller, Ph.D.

Mary Politi, Ph.D.

Ana Baumann, Ph.D.

Bethany Pennington, PharmD

Katherine Clifton, M.D.

Theresa Cordner

Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.

Study staff responsible for administering ratings throughout the study are blinded. This blinding is kept throughout the study until data collection is complete. At the end of the follow-up, the study coordinator will complete a blinding question to try to guess the arm to which each participant was allocated. This will allow to determine whether the blinding procedures in the study were effective.

Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic 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.

* 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.

National Institute of Mental Health (NIMH)

Washington University School of Medicine

Behavioral activation, an emerging psychological intervention approach, has potential in alleviating negative emotions among cancer patients. The intervention group underwent an eight-week behavioral activation program designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles.

behavioral activation

The majority of cancer patients experience varying degrees of psychological distress and physical symptoms due to the presence of cancer or the process of treatment. These symptoms are closely associated with inflammatory markers and patient prognosis, highlighting the urgent need for effective psychological intervention methods. Behavioral activation, an emerging psychological intervention approach, requires further investigation regarding its potential in alleviating negative emotions among cancer patients. Therefore, the investigators conducted a randomized controlled trial (RCT) to investigate whether (1) behavioral activation can ameliorate negative emotions and physical symptoms in cancer patients; (2) behavioral activation can contribute to improved survival outcomes for these patients; and (3) behavioral activation can enhance NLR levels and other clinical indicators among individuals with cancer.

The investigators aimed to recruit a total of 390 cancer patients, comprising 170 individuals diagnosed with esophageal and gastric cancer, 100 individuals with colorectal cancer, and 120 individuals with lung cancer. These patients were recruited from the Department of Oncology at the Second Affiliated Hospital of Anhui Medical University between March 2023 and November 2023. They were randomly allocated into two groups: an intervention group (behavioral activation+care as usual, BA+CAU) and a control group (care as usual, CAU). The intervention group underwent an eight-week behavioral activation program (see Detailed Description) designed to promote engagement in meaningful activities that are physically and emotionally rewarding while reducing involvement in maladaptive emotional cycles. Both the intervention group and the control group received standard care along with conventional treatment for their respective cancers.

This study aims to demonstrate the significant efficacy of behavioral activation in improving negative emotions, somatic symptoms, quality of life, and clinical inflammatory indicators among cancer patients. Furthermore, it may potentially enhance patient survival rates, thereby offering a novel approach for psychological intervention in cancer patients and contributing to multidisciplinary treatment and management strategies. The intervention measures employed in this study do not involve any pharmacological treatments or hazardous activities. For illiterate or less educated patients, the informed consent process and questionnaire collection will be conducted using methods that ensure their full comprehension (e.g., verbal explanations, visual aids). Additionally, patients with evident cognitive impairments were excluded from the study.

The investigators have implemented a questionnaire system on the WJX website (https://www.wjx.cn/) to collect patient information through both paper and electronic questionnaires. The psychological measurement questionnaires are stored electronically, while socio-demographic data and clinical indicators are collected in the hospital's medical record management system. Subsequently, all data is summarized and saved in local Excel files and SPSS files for specialized analysis by data analysts. Patient names are anonymized within the database, ensuring strict confidentiality of personal information such as contact details and home address.

Possible statistical methods include descriptive statistical analysis, generalized estimating equation or repeated measures analysis of variance, structural equation modeling, correlation analysis and regression, survival analysis, etc.

This study was evaluated by experts in the field, including two psychologists and one oncologist to ensure its scientifcity and feasibility. The BA intervention was administered 8 times, once a week. Each session lasted for 15-30 min. All the interventions were conducted by the same psychological consultant. The first BA intervention for each patient was conducted in person, with a psychological consultant in a separate treatment room. Thereafter, the psychological intervention sessions for most patients were conducted via audio calls or video conferencing means (WeChat or phone). With informed consent from all participants, each audio call was recorded, and these recordings served as the basis for the examiner's assessment of the quality of the intervention. If the BA intervention could not be conducted at the scheduled time due to patients' physical condition or other reasons, it was rescheduled within 3 to 5 days from the specified intervention time. In addition to the BA intervention, the BA+CAU group received comparable cancer care and treatment to that of the control group.

The aim of BA is to promote engagement in meaningful and pleasurable activities while reducing those that perpetuate negative emotional cycles. The investigators developed a 8-week program based on the Brief Behavioral Activation Treatment for Depression: Revised Treatment Manual. Patients were assessed weekly and instructed to keep track of their activities from the past week, rating each activity for its level of pleasure and meaning, as well as providing an overall rating for the week. Based on these scores, patients can identify which activities are beneficial or detrimental to their mental health and create a plan to increase positive activities in the following week. If they encounter difficulties achieving these goals, the investigators encourage them to break down larger objectives into smaller specific tasks or make "contracts" with others for support. Additionally, if patients are less active, the investigators suggest selecting some activities from our list (family, social, religious, etc.) as targets.

8-week program

Sessions Key elements Weekly Assignments Session1 (Special session) Offline intervention 1.Discussion of Depression 2.Introduction to Treatment Rationale. What about stressful life events and loss in participant's life? 3.Introduction to Daily Monitoring: (1) Importance and enjoyment (or meaning and happiness) ratings. (2) When should participants complete the Daily Monitoring Form? 4.Important Points About the Structure of This Treatment Complete Daily Monitoring Form Session 2 (Special session) Via telephone or Wechat: 1.Daily Monitoring: Review Assignment, Troubleshooting 2.Treatment Rationale: Review 3.Complete Life Areas, Values, Activities Inventory (Appendix) 1. Complete Daily Monitoring 2. Review and edit Life Areas, Values, and Activities Inventory Session 3 (Special session) Via telephone or Wechat: 1.Daily Monitoring: Review Assignment 2.Life Areas, Values, and Activities Inventory: Review assignment 3.Activity Selection and Ranking 1.Daily monitoring 2.Continue to review and edit Life Areas, Values, and Activities Inventory 3. Review and edit activity selection and ranking Session 4 (Special session) Via telephone or Wechat: 1.Daily Monitoring: Review Assignment 2.Daily Monitoring with Activity Planning Daily Monitoring with activity planning for upcoming week Session 5 (Special session) Via telephone or Wechat: 1.Daily Monitoring With Activity Planning: Review Assignment 2.Contract: Ensure the timely completion of activities through effective collaboration with other people 3.Daily Monitoring With Activity Planning for the Upcoming Week 1.Daily monitoring with activity planning for the upcoming week 2.Continue adding/editing contracts Session 6 (Maintenance Session) Via telephone or Wechat: 1.Daily Monitoring With Activity Planning: Review Assignment 2.Life Areas, Values, and Activities Inventory: Concept Review and Edit 3.Daily Monitoring With Activity Planning for the Upcoming Week 1.Daily monitoring with activity planning for the upcoming week 2.Continue adding/editing Contracts Session 7 (Maintenance Session) Via telephone or Wechat: 1.Daily Monitoring With Activity Planning: Review Assignment 2.Life Areas, Values, and Activities Inventory: Concept Review and Edit 3.Daily Monitoring With Activity Planning for the Upcoming Week 1.Daily monitoring with activity planning for the upcoming week 2.Continue adding/editing contracts Session 8 (Maintenance Session) Via telephone or Wechat: 1.Daily Monitoring With Activity Planning: Review Assignment 2.Daily Monitoring With Activity Planning for the Upcoming Week 3.Preparing for the End of Treatment 1.Daily monitoring with activity planning for the upcoming week 2.Continue adding/editing contracts

Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients

The sociodemographic data includes gender, age, smoking, drinking, working, marital status, and education level. This information is extracted from the medical record.

The status of tumor encompasses the primary tumor site, TNM stage-based tumor staging, histological subtype of the tumor, as well as the past, present, and future treatment strategies for the neoplasm. This information is extracted from the medical record.

The Body Mass Index (BMI) is a widely accepted international standard for assessing adiposity and overall health status in individuals. It is calculated by dividing an individual's weight by the square of their height, expressed in kilograms per square meter (kg/m\^2). This information is extracted from the medical record.

Biochemical index includes blood glucose, triglyceride and total cholesterol, which reflect the metabolic level in the body, expressed in mmol/L. This information is extracted from the medical record. This information is extracted from the medical record.

The measurement of blood pressure is typically presented as the ratio between systolic and diastolic pressures, expressed in millimeters of mercury (mmHg). This information is extracted from the medical record.

NRS is a recommended method by the European Society for Parenteral and Enteral Nutrition to assess nutritional risk in hospitalized patients, consisting of three components: nutritional status, disease severity, and age. The total score ranges from 0-7 points with higher scores indicating poorer nutritional status. A total score ≥3 points indicates the presence of nutritional risk requiring nutritional support while a total score \<3 points necessitates weekly review of the patient's nutritional assessment; if subsequent reviews yield a score ≥3 points, then initiation of the nutritional support program is warranted.

VAS is a widely utilized tool for pain assessment in clinical practice in China. This method involves employing a 10cm long sliding ruler, featuring 10 gradations on one side and "0" and "10" at the opposing ends. A score of 0 indicates the absence of pain, while a score of 10 represents the utmost intolerable pain.

KPS is utilized for the evaluation of cancer patients' physical condition and daily functional capacity. The total score ranges from 0 to 100, with higher scores indicating improved overall health, enhanced physical abilities, better tolerance towards treatment-related side effects, and consequently a greater potential for comprehensive therapeutic interventions.

Psychological distress is assessed using the DT. The DT is a self-assessment of the level of psychological distress experienced in the past week (including the day of filling in this questionnaire). It covers practical, family, emotional, spiritual/religious and physical problems. The scale ranges from 0 to 10. The higher the score, the greater the level of psychological distress or psychological distress.

Anxiety and depression were assessed using the HADS. The HADS scale is mainly used for screening anxiety and depression in general hospital patients. It includes two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored on a 4-level scale according to the frequency of symptoms in the past month. Each item has a total of four levels, ranging from 0 to 3, with higher scores indicating more severe anxiety or depression symptoms. The total scores for anxiety and depression are 0-21.

Quality of life was assessed using the EORTC QLQ-C30. The EORTC QLQ-C30 is a cancer-specific tool that contains 30 items. The EORTC QLQ-C30 includes five important functional areas -- physical, emotional, role, cognitive, and social; two items assess global quality of life; three symptom scales assess fatigue, vomiting, and pain; and six subscales to assess dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties. Higher scores on the functional scales represent higher levels of functioning, meaning healthier cancer patients, while higher scores on the symptom scales or items represent higher levels of symptoms or problems, or less healthy cancer patients.

The Pittsburgh Sleep Quality Index (PSQI) is used to assess subjective sleep quality over the past month. The PSQI consists of 19 self-rated items and 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, hypnosis use, and daytime dysfunction. The scores range from 0 to 3 and the total score is 0 to 21; higher scores indicate poorer sleep quality.

Cancer-related fatigue was assessed using the PFS-R. The scale consists of 22 items and 5 open-ended questions, and patients were evaluated using a scale of 0 to 10, with the final score as total score/item number. The PFS-R described four dimensions of subjective fatigue according to the following subscales: behavioral severity subscale (6 items), cognitive severity subscale, emotional meaning subscale (5 items), and sensory/emotional severity subscale (5 items). Fatigue was divided into three grades according to the score: mild fatigue (1-3 points), moderate fatigue symptoms (4-6 points), and severe fatigue symptoms (7-10 points).

The physical activity level was assessed by the short version of the International Physical Activity Questionnaire (IPAQ). There were seven questions in total, six of which asked about the physical activity of individuals. The question structure was the same as that of the long version of the IPQ, except for the activity intensity part. The short version of the IPQ was divided into walking, moderate intensity and high intensity to ask about the weekly frequency and cumulative time of activities of different intensity, taking into account the four physical activity levels of work, transportation, housework and gardening, and leisure. Participants were categorized into low, moderate, and high physical activity groups based on their overall level of physical activity as well as the frequency and duration of daily physical activities over a span of one week.

The Brief Resilient Coping Scale was used to assess resilience. It has four items and uses a 5-point Likert scale "from '1' = does not describe me at all to '5' = describes me very much."25 The total score ranges from 4 to 20; higher scores indicate greater resilience.

Social support was assessed using the Perceived Social Support Multidimensional Scale. The scale includes 12 self-rated items and uses a 7-point scoring method, with scores ranging from strongly disagree to strongly agree, with higher scores indicating higher perceived social support. This study used the scale to assess the perceived degree of support from family, friends and others.

Self-efficacy was assessed using the General Self-Efficacy Scale. The scale consists of 10 items, each of which is scored between 1 and 4, and the total score is 10-40 divided by 10. The higher the score, the higher the self-efficacy.

The effectiveness of the BA intervention was assessed using the BADS-A, a 7-item scale that allows each item to be scored on a scale of 0 to 6 (from "none at all" to "completely"), with a total score of 0 to 42. The higher the score, the better the BA intervention.

The Social Impact Scale is used to evaluate the stigma of patients with chronic diseases such as cancer. The scale has 24 items, including 4 dimensions, which are social exclusion, economic discrimination, internal stigma and social isolation. The scale adopts the Likert 4-point scoring method, with 1-4 points from "strongly disagree" to "strongly agree", and the total score ranges from 24 to 96. The higher the score, the greater the stigma of patients.

Fear of recurrence was assessed with the Fear of Cancer Recurrence Inventory- Short Form, which consists of 9 questions and is graded on a 0 to 4 scale with a total score of 0 to 36, with higher scores indicating greater fear of recurrence, with a cutoff score of 13 for high-level FCR.

The FACT-Cog is used to assess perceived cognitive function and its impact on quality of life in cancer patients. It includes 37 items across four dimensions (subjective cognitive impairment, evaluation by others, subjective cognitive ability, and impact of cognitive impairment on quality of life), with each item scored on a scale of 0 to 5, ranging from never/not at all (0) to several times/very often (4). The total score is 0 to 148, with lower scores indicating greater cognitive impairment.

Progression-free survival (PFS) is the time from randomization to the first progression or death from any cause. The criteria for tumor progression are based on the RECIST 1.1 version.

Time to progression (TTP) is the time from randomization to any aspect of tumor progression. The criteria for tumor progression are based on the RECIST 1.1 version.

C-reactive protein (CRP) expressed in mg/L, serves as a non-specific inflammatory biomarker with higher values indicating elevated levels of systemic inflammation. This information is extracted from the medical record.

NLR is an inflammatory marker, which is the ratio of neutrophils to lymphocytes. The higher the value is, the higher the inflammatory level may be. This information is extracted from the medical record.

PLR is an inflammatory marker, a ratio of platelets to lymphocytes. A higher value of it indicates a higher level of inflammation in the body. This information is extracted from the medical record.

MLR is an inflammatory indicator, which is the ratio of macrophages and lymphocytes. The higher the value is, the higher the inflammatory level in the body is. This information is extracted from the medical record.

SII is an inflammatory indicator, which is calculated as follows: SII=(neutrophil×platelet)/lymphocytes. A higher value indicates an elevated level of inflammation within the body. This information is extracted from the medical record.

PIV is an inflammatory indicator, which is equal to neutrophils × monocytes × platelets/lymphocytes. The higher the value is, the higher the inflammatory level in the body is. This information is extracted from the medical record.

Carcinoembryonic antigen (CEA) is a broad-spectrum tumor marker, commonly found in gastrointestinal tumors as well as breast and lung cancers. Normal values are generally \<5.0ng/ml. This information is extracted from the medical record.

Carbohydrate antigen 19-9 (CA19-9) is a tumor marker associated with pancreatic, gallbladder, colon, and stomach cancers, with a normal value of \<37kU/L. This information is extracted from the medical record.

Carbohydrate antigen 72-4 (CA72-4) is one of the tumor markers for the detection of gastric cancer and various digestive tract cancers. The detection of gastric cancer exhibits a high level of specificity, with a cut-off value set at \>6 U/mL. This information is extracted from the medical record.

Neuron-specific enolase (NSE) is a specific marker for tumors such as small cell lung cancer (SCLC), with normal value \<16.3ng/ml. This information is extracted from the medical record.

Squamous cell carcinoma associated antigen (SCC) is a tumor marker associated with squamous cell carcinomas such as lung squamous cell carcinoma and esophageal squamous cell carcinoma, with a cut-off value of 2.5μg/L. This information is extracted from the medical record.

Anhui Medical University

Professor

Behavioral Symptoms

Support and information + Behavioral activation

Support and information + Systematic exposure with mindfulness training

Support and information + Promotion of health behaviors

Support and information + Behavioral activation + Systematic exposure with mindfulness training

Support and information + Behavioral activation + Promotion of health behaviors

Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors

Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors

Emotional and technical support. Information about the long-term effects of cancer.

Support and information

Behavioral activation with existential themes and emphasis on values and relationships.

Behavioral activation

Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.

Systematic exposure with mindfulness training

An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Promotion of health behaviors

Erland Axelsson, PhD

Negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. Internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. In this factorial pilot study, 48 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address common negative psychological long-term effects of cancer. The aim of this study is to assess the feasibility of the study design and online treatment format. Key feasibility outcomes include interest in the study, patient-reported credibility of the intervention, adherence to the treatment protocol, satisfaction with the treatment, acceptability of the measurement strategy, missing data rates, adverse events, and preliminary efficacy on anxiety, depression, the fear of recurrence, and health-related quality of life.

Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors

Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms

Individual participant data from this pilot study fall under Swedish and European Union data protection and privacy legislation and can therefore not be share in their entirety. Reasonable requests may be directed to the corresponding author, and will be considered on a case-by-case basis.

A key feasibility outcome of this pilot study is the overall experience of study administrators and therapists tasked with the assignment and delivery of treatment variants in accordance with the randomized factorial design. After the main phase, all study administrators and therapists will be asked to rate the feasibility of the planned study design from 0 ("not feasible at all") to 10 ("fully feasible"), which will reported as a mean (SD) and median.

Credibility/Expectancy scale (C/E scale). Theoretical range: 0-50, where a higher score indicates higher credibility/expectancy.

Number of modules initiated, as registered by the clinician.

Number of completed exercises, as based on a short weekly questionnaire tailored to suit each treatment arm, with corresponding questions about the number of days devoted to exposure exercises, days devoted to activity planning, and days devoted to the promotion of health behaviors.

Number of measurements completed at each measurement point after the pre-treatment assessment. Preregistered target: at least 70% non-missing at the post-treatment and follow-up assessments.

Perceived strain caused by the measurement strategy. Preregistered target: at least 75% with a rating below 7 from 0 ("not at all stressful/distressing") to 10 ("extremely stressful/distressing").

The 8-item Client Satisfaction Questionnaire (CSQ-8). Theoretical range: 8-32, where a higher score indicates higher satisfaction.

Likert items pertaining to satisfaction with components.

Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)

20-item Negative Effects Questionnaire (NEQ-20). This will be reported as the proportion of endorsed items in the following subdomains: increase in symptoms, perceived insufficient quality of treatment, dependency, stigma, and hopelessness.

General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)

Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression)

9-item Fear of Cancer Recurrence Inventory (FCRI-9, theoretical range: 0-36, where a higher score indicates a more pronounced fear of cancer recurrence)

36-item Short Form Health Survey (SF-36, scored as a Mental Health Component Score and a Physical Health Component Score according to standard norms, both with a theoretical range of 0-100, where a higher score indicates a higher health-related quality of life)

14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more health anxiety).

Somatic Symptom Scale 8 (SSS-8, theoretical range: 0-32, where a higher score indicates a higher somatic symptom burden). Exploratory secondary analyses will be based on individual items, each scored 0-4.

Body Image Scale (BIS, theoretical range: 0-30, where a higher score indicates a higher level of body image distress).

12-item WHO Disability Assessment Schedule 2.0 (WD2-12, theoretical range: 0-100, where a higher score indicates more disability).

3-item Behavioral Activation for Depression Scale - Activation (BADS-AC-3, theoretical range: 0-18, where a higher score indicates a higher level of behavioral activation).

Symptom Preoccupation Scale (preliminary scale). A higher score indicates higher degree of preoccupation with symptoms. This is to be regarded as an an item pool, and the scale is is under development, which means that the total range cannot be preregistered.

Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ, theoretical range 0-99, where a higher score indicates a higher level of physical activity). If necessary for statistical modeling, the GSLTPAQ will be dichotomized to indicate active (≥24) vs. insufficiently active (\<24).

Based loosely on the Arthritis Self-efficacy Scale. Theoretical range of 0-60, where a higher score indicates a higher level of general health-related self-efficacy.

Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance)

Alcohol Use Disorders Identification Test (AUDIT, theoretical range: 0-40, where a higher score indicates more problematic alcohol use).

Drug Use Disorders Identification Test (DUDIT, theoretical range: 0-44, where a higher score indicates more problematic substance use).

Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress).

Karolinska Institutet

Principal Investigator

* 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.

Michael Avidan, MBBCh, FCASA

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 have 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.

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.

Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

Patient Participants

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

One participant who signed consent, was considered eligible, and was enrolled to the study ended up having their surgery canceled and became ineligible for the study after enrollment.

Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants

Reach of the Intervention Bundle as Measured by the Number of Participants Who Completed the Intervention Out of the Participants Who Agreed to Participate in the Study

Baseline

1 month

3 months

Completeness of Planned Primary Outcome Data Collection at Specified Timepoints as Measured by the Number of Participants Who Completed 100% of the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Eligible for Consent and Enrollment

Enrolled

Started Intervention

Completion of Intervention

Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention

Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention

Sessions for both arms (BP \& SP) will be administered remotely via video-conference and/or telephone (per patient preference) at the following timeline:

* Full participants (not training cases): Ten sessions (30-50 minutes each) will be delivered approximately weekly over a 10-week period (+10 weeks).
* Training case participants: Ten sessions (30-50 minutes each) will be delivered over an approximately 5-week period (+10 weeks).

Supportive Psychotherapy

Rebecca Saracino, PhD

Christian Nelson, PhD

The purpose of this study is to find out if a psychotherapy method called behavioral activation (BA) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in Older Adult Cancer Survivors (OACS)

A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Patient Health Questionnaire 9 (PHQ-9): The PHQ-9 consists of nine items, each of which corresponds to one of the nine symptoms required for a diagnosis of a major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders. Respondents are asked to rate how often they have been bothered by each of the nine symptoms over the preceding two weeks. Respondents rate each item on a four-point scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day). Its reliability and validity have been established in diverse general and medical populations. Total scores range from 0-27; In outpatient cancer settings, psychometric research suggests that a score of ≥8 indicates clinically significant depressive symptoms and should be used as a clinical cut-off .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery	NCT05685511	Older Adults Anxiety Depression Major Surgical ... Major Surgical ...	Behavioral Acti... Medication Opti...	60 Years -	Washington University School of Medicine
Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients	NCT06348940	Cancer Patients	behavioral acti...	18 Years -	Anhui Medical University
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors	NCT06046573	Cancer Survivor... Anxiety Depression	Support and inf... Behavioral acti... Systematic expo... Promotion of he...	18 Years -	Karolinska Institutet
Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients	NCT06348940	Cancer Patients	behavioral acti...	18 Years -	Anhui Medical University
Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study	NCT05110690	Older Adults Anxiety Depression Cardiac Surgery Orthopedic Surg... Major Surgical ... Major Surgical ...	Behavioral Acti... Medication Opti...	60 Years -	Washington University School of Medicine
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors	NCT05574127	Survivorship	Behavioral Acti... Supportive Psyc...	65 Years -	Memorial Sloan Kettering Cancer Center
Effects of Behavioral Activation on Negative Emotions, Cancer-related Symptoms and Clinical Indicators in Cancer Patients	NCT06348940	Cancer Patients	behavioral acti...	18 Years -	Anhui Medical University
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors	NCT06046573	Cancer Survivor... Anxiety Depression	Support and inf... Behavioral acti... Systematic expo... Promotion of he...	18 Years -	Karolinska Institutet

Spots Global Cancer Trial Database for behavioral activation