Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Conflict Resolution
  • Depression
  • Stress
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Objective: To assess the feasibility, acceptability and effectiveness of PATH under naturalistic conditions. Hypotheses: H1: Greater than 50% of users referred to the problem-solving module will complete at least 4 treatment sessions. H2: Users will report that problem-solving module is acceptable a...

Objective: To assess the feasibility, acceptability and effectiveness of PATH under naturalistic conditions. Hypotheses: H1: Greater than 50% of users referred to the problem-solving module will complete at least 4 treatment sessions. H2: Users will report that problem-solving module is acceptable as a stand-alone treatment for depression. H3: On average, user's self-reported depression severity scores on the PHQ-9 will decrease over time. H4: More workers and family members will access the program directly than through referral from a clinician. H5: Users will find the stress and conflict content acceptable and helpful in learning better stress and conflict management skills. H6: On average, user self-reported stress severity scores on the PSS will decrease over time. Procedures: Consecutive employees and faculty members receiving evaluations in the EAP programs of Dartmouth-Hitchcock Medical Center (DHMC) and Dartmouth College and identified as being depressed or having issues with conflict or stress and as potentially able to benefit from using PATH will be referred to the program. The programs are also available to any adult on their own or through their organization at: Path.Dartmouth.edu When the user signs up, they create a username and password and select they do not have a token and then are presented with an electronic consent. When they click accept (providing consent), they are given access to the programs. Materials: PATH programs available on the internet. Data Collection: All study data will be automatically collected by the suite of programs (problem-solving, stress management, conflict management). Evaluation data (i.e., PHQ-9 scores and acceptability of the program) will be collected at each session. Information entered into the program as part of using PATH (e.g., the types of problems worked on, success with solving the problems, satisfaction with effort, compliance with homework, obstacles encountered) will also be automatically stored. Stress and conflict management programs collect the user input, the paths they take, and evaluation data. Users will create a login that will enable their use of the program. The web-based programs are hosted at Dartmouth College. The web-app has passed an Acunetix security scan, run by Dartmouth Central Computing. It has been set up as a DISC level 3 security server. This has been evaluated by the Research Privacy and Security Officer at Dartmouth College and has been approved for use. Only gender will be collected. No identifying information (e.g., name, address, dob, SS#) will be collected. All entered data will be stored according to the assigned ID. To monitor for potentially nefarious hackers, IP addresses connecting to our servers will be collected and geo-located to ensure the router or internet service provider they are connecting from corresponds to those expected based on our research locations. We do not propose to screen the participants for the study. Participants will be referred to the programs by their EAP counselor at Dartmouth-Hitchcock Medical Center, their FEAP counselor at Dartmouth College, their provider at DHMC, or by advertisement through Live Well Work Well or Dartmouth College EAP. Participants may also be referred through an outside organization or use the program on their own. As an effectiveness study, we are interested in making the programs available without exclusions to the general population. There are no eligibility criteria based on severity level of depression or suicidal ideation. There are no exclusion criteria for participation in the study. Suicidality is not a reason for not being enrolled in the study. The program is being made available to Geisel Medical Students, as well as Dartmouth College and Dartmouth Hitchcock Employees through the Employee Assistance Program (EAP) at Dartmouth-Hitchcock Medical Center (DHMC), the Faculty and Employee Assistance Program (FEAP) at Dartmouth College and their D-H primary care physicians in order to assess their feasibility, acceptability and effectiveness under naturalistic conditions. Additionally, to test whether workers and their families are likely to access on-line treatment if they can access the treatment directly, we will make it possible for participants to connect to the programs directly, without referral from a clinician. We will be additionally testing these programs through making them freely available on the internet as well as through organizations that express interest in using them with their employees, members, etc. who are 18 or older. Participants from outside of Dartmouth populations will be self-referred or referred to the program by people in their organization. We will not direct how the organizations will implement use of the programs but will collect information from the organizations about their implementation strategies. We may share usage data with the organizations but will not provide information for specific individuals. For these populations, we will be analyzing usage data (i.e. completion of modules, return visits to modules), data collected by the program (i.e. progress through the modules), acceptability (i.e. from the questionnaires embedded in the programs such as the depression program), effectiveness (i.e. for those programs that include repeated assessments), and implementation strategies from different organizations that partner with us to use the program (i.e. reminder systems, adjunctive use with therapist, use in group settings).

Tracking Information

NCT #
NCT02726061
Collaborators
Not Provided
Investigators
Principal Investigator: Jay C Buckey, M.D. Dartmouth-Hitchcock Medical Center