Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the extent to which an online pathway to depression treatment (iPath*D) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators will determine the extent to which an online pathway to depression treatment (iPathD) is acceptable and usable to patients receiving cancer treatment who report symptoms of depression. iPathD will be designed to increase screening, mental health literacy, and treatment access. Patients will access their iPath*D account online to review their PHQ-9 score and its interpretation, followed by an interactive depression decision aid comparing information on a range of online and in-person treatment options. Upon review of the decision aid, participants will be able to directly connect to a treatment path via embedded hyperlinks in the decision aid.
The investigators will determine the usability, acceptability, and feasibility of iPathD. The investigators will explore the hypothesis that iPathD will be highly usable, acceptable to patients, feasible to implement, and will result in improved mental health literacy, and greater treatment access.
This approach uses an open-label, single arm pilot, with adult patients receiving treatment for cancer in a rural cancer clinic, St Johnsbury VT (NCCC North) (n=30) with moderate-severe depression.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: iPath*D An online platform that connects patients screening positive for clinically significant depression in cancer settings to a range of online and inperson evidence-based treatments, facilitated by an interactive DA. |
Other: iPath*D
Online pathway from screening to treatment for depression in cancer patients.
|
Outcome Measures
Primary Outcome Measures
- Change in Mental Health Literacy [Baseline, 2 weeks]
The validated 27-item multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding & beliefs. Scores range from 0 - 27, with higher scores indicating higher MHL.
- System usability [2 weeks]
System Usability Scale (10 items; mean ≥68/100),
- Acceptability of intervention [2 weeks]
Acceptability of Intervention Measure (4 items), mean ≥4/5
- Feasibility of intervention [2 weeks]
Feasibility of Intervention Measure (4 items), mean ≥4/5
- Change in number of patients selecting a treatment path to access [2 weeks, 4 weeks, 6 weeks]
Click on link to access online treatment service | indicate in self-report survey accessing local resources
Secondary Outcome Measures
- Change in PHQ-9 completion (exploratory outcome) [Baseline, 2 weeks, 4 weeks, 6 weeks]
Number of patients who complete Patient Health Questionnaire (PHQ-9), a validated nine item depression scale. A score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
- Change in treatment initiation (exploratory outcome) [2 weeks, 4 weeks, 6 weeks]
Proportion of patients who self-report treatment initiation e.g., fill antidepressant prescription, visited with psychiatrist for talk therapy, began a cCBT program, or other service
- Change in treatment adherence (exploratory outcome) [2 weeks, 4 weeks, 6 weeks]
Proportion of patients who self-report continued adherence to treatment e.g., antidepressant refill (yes/no), number of talk therapy sessions completed, or Computerised Cognitive Behavioural Therapy (cCBT) modules completed
- Decisional regret (exploratory outcome) [6 weeks]
The Decisional Regret Scale assesses satisfaction with a healthcare decision (5-items, scores range from 0-100, with higher scores indicating high regret)
- Change in PHQ-9 score (exploratory outcome) [Baseline, 2 weeks, 4 weeks, 6 weeks]
Response; 5-point reduction in baseline PHQ-9 score. Remission; PHQ-9 score of <5 points
- Change in quality of life (exploratory outcome) [Baseline, 2 weeks, 4 weeks, 6 weeks]
Functional Assessment of Cancer Therapy-General (FACT-G) scale (27-items, scores range from 0-108 with higher scores indicating higher quality of life)
Eligibility Criteria
Criteria
Inclusion criteria
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Adults (≥18 years)
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New patients who are beginning treatment at NCCC North and returning for their chemo teach or radiation simulation visit
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Can communicate in English
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10≤ PHQ-9 ≤27
Exclusion criteria
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Mild Depression (PHQ-9 ≤10)
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Individuals who screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6 on the Columbia-Suicide Severity Rating Scale (C-SSR).
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Individuals with bipolar disorder or psychosis (documented in the EMR)
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Individuals currently receiving treatment for a mental health condition (documented in the EMR or self-reported during eligibility screening)
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Significant cognitive impairment (Callahan's Six Item Screener of cognitive function ≤ 4; Self-reported during eligibility screening)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Paul Barr, Ph.D., Dartmouth College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 02001240
- R21CA249767