Internet Based Psychological Support

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2031-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Computerized Intervention for Depression

NCT02655588

Depression

COMPLETED NA

Telephone-Based Counseling for Depression in Parkinson's Disease

NCT02505737

Depression Parkinson's Disease

COMPLETED NA

A Trial of Two On-Line Interventions for Child Brain Injury

NCT00178022

Traumatic Brain Injury Depression Anxiety Disorders

COMPLETED NA

Telehealth Psychotherapy for Depression in Parkinson's Disease

NCT03993041

Depression Parkinson's Disease

COMPLETED NA

Web Based Therapist Training in Interpersonal Psychotherapy for Depression

NCT03177304

Depression

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Stress Conflict Resolution

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Internet Based psychological support

The internet-based psychological support intervention (PATH) is an internet based Problem Solving Therapy, stress management training and conflict management training program.

Group Type EXPERIMENTAL

Internet-based psychological support

Intervention Type BEHAVIORAL

A behavioral therapy called Problem Solving Therapy, conflict management training, and stress management training will be administered via an interactive multimedia program (PATH) to participants referred from their Employee Assistance Program and the general public for the management of depression, stress, and conflict.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Internet-based psychological support

A behavioral therapy called Problem Solving Therapy, conflict management training, and stress management training will be administered via an interactive multimedia program (PATH) to participants referred from their Employee Assistance Program and the general public for the management of depression, stress, and conflict.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PATH

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)