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DepressionNCT02726061

Internet Based Psychological Support

A study testing Internet-based psychological support in people with Depression and Stress, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Stress, Conflict Resolution
What is being tested?
Internet-based psychological support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
Feb 2016to Feb 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Jay C Buckey, M.D., 603-650-6012, jay.c.buckey.jr@dartmouth.edu

    Jay C Buckey, M.D

    Recruiting

Other trials in United States

About this study

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.

Read more

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.

Read the detailed 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 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).

Being tested
Internet-based psychological support
Medical subject headings
Depression, Negotiating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based psychological supportBehavioural

    Also called PATH

    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.

Study groups in NCT02726061
Study groupRoleWhat they receive
Internet Based psychological supportExperimentalThe internet-based psychological support intervention (PATH) is an internet based Problem Solving Therapy, stress management training and conflict management training program.
Receives: Behavioral: Internet-based psychological support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants referred to the PATH program that log on to the program.

    Does the participant log on to the program? yes/no

    Measured: Five years

Secondary outcomes (1)
  1. Participant reports of the acceptability of the PATH program

    Acceptability questionnaire

    Measured: Five years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionFeb 2031 (estimated)
  4. Study completionFeb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02726061
Sponsor's protocol ID
STUDY00028777
Status last verified
Jul 2026
First submitted
29 Feb 2016
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Sandoval LR, Buckey JC, Ainslie R, Tombari M, Stone W, Hegel MT. Randomized Controlled Trial of a Computerized Interactive Media-Based Problem Solving Treatment for Depression. Behav Ther. 2017 May;48(3):413-425. doi: 10.1016/j.beth.2016.04.001. Epub 2016 May 3.

    PubMed 28390503
  • Berman MI, Buckey JC Jr, Hull JG, Linardatos E, Song SL, McLellan RK, Hegel MT. Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial. Behav Ther. 2014 May;45(3):358-75. doi: 10.1016/j.beth.2014.02.001. Epub 2014 Feb 7.

    PubMed 24680231
  • Rose RD, Buckey JC Jr, Zbozinek TD, Motivala SJ, Glenn DE, Cartreine JA, Craske MG. A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program. Behav Res Ther. 2013 Feb;51(2):106-12. doi: 10.1016/j.brat.2012.11.003. Epub 2012 Nov 21.

    PubMed 23262118
  • Anderson AP, Fellows AM, Binsted KA, Hegel MT, Buckey JC. Autonomous, Computer-Based Behavioral Health Countermeasure Evaluation at HI-SEAS Mars Analog. Aerosp Med Hum Perform. 2016;87(11):912-920. doi: 10.3357/AMHP.4676.2016.

    PubMed 27779949
  • Detweiler Guarino I, Cowan DR, Fellows AM, Buckey JC. Use of a Self-guided Computerized Cognitive Behavioral Tool During COVID-19: Evaluation Study. JMIR Form Res. 2021 May 31;5(5):e26989. doi: 10.2196/26989.

    PubMed 33973856

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based psychological support in people with Depression and Stress, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anastasiya Kobrina (603-646-5331, anastasiya.kobrina@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants referred to the PATH program that log on to the program. (time frame: Five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02726061, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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Internet Based Psychological Support (NCT02726061) | AzTrials