Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
- Conditions
- CancerDepression
- Interventions
- Other: iPath*D
- Registration Number
- NCT05302375
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
- Detailed Description
The investigators will 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. iPath\*D 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 iPath\*D. The investigators will explore the hypothesis that iPath\*D will be highly usable, acceptable to patients, feasible to implement, and will result in improved mental health literacy, and greater treatment access. The tool for the study was developed during a preliminary portion (Aim 1) of the project, under D-H IRB number STUDY02001240 .
This approach uses an open-label, single arm pilot, with adult patients receiving treatment for cancer in a rural cancer clinic, St Johnsbury, VT (Dartmouth Cancer Center North) (n=30) with moderate-severe depression, Aim 2 of the project.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description iPath*D 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.
- Primary Outcome Measures
Name Time Method 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 Mental Health Literacy (MHL) Baseline, 2 weeks A modified 10-item version for the validated multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding \& beliefs. Higher scores indicate higher MHL.
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
Name Time Method 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
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 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 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
Change in quality of life (exploratory outcome) Baseline, 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)
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
Trial Locations
- Locations (1)
Dartmouth Cancer Center St. Johnsbury
🇺🇸Saint Johnsbury, Vermont, United States