Internet Based Psychological Support



Status:Recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:February 2016
End Date:February 2021

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The investigators have developed interactive, multimedia-intensive, computer-based treatment
programs that include depression (Problem-Solving Therapy), stress management, and conflict
management. Together the three modules are called PATH.

The problem-solving module is based on an evidence-based psychotherapy called Problem-Solving
Therapy in which depressed patients identify problems in their lives and work through a
structured format for solving these problems. We have subjected the problem-solving module to
Phase 1-3 feasibility, acceptability and efficacy trials which have been positive and without
adverse events.

The conflict program uses a cognitive-behavioral-therapy-based approach. The program includes
a conflict briefing, an interactive conflict simulation, a conflict assessment tool, an
interactive training exercise in interest-based negotiation, and a cognitive restructuring
exercise.

The stress program also uses a cognitive behavioral therapy (CBT) approach. In the program,
the mentor introduces the "stress pyramid", which demonstrates how stress triggers can lead
to different feelings, actions and thoughts, which are analogs to the CBT realms of
dysfunctional emotions, maladaptive behaviors, and faulty cognitive processes. The stress
management content is delivered over 6 sessions, with each session including exercises in the
3 domains of thoughts, feelings, and actions. The program includes briefings, cognitive
restructuring exercises, interactive scenarios, and self-assessments. This program has been
evaluated with law and business students and was shown effective in reducing stress levels.

The purpose of the current study is to make the problem-solving, stress, and the conflict
modules available through the internet for any adult 18 or older in order to assess their
feasibility, acceptability and effectiveness under naturalistic conditions.

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).

Inclusion Criteria:

- Adult employees (age 18 and older) and faculty attending the EAP programs of DHMC and
Dartmouth College complaining of depression.

- Any Adult (age 18 or older)

Exclusion Criteria:
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Jay C Buckey, M.D
Phone: 603-650-6012
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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