NCT02726061

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable depression

Timeline
58mo left

Started Feb 2016

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Feb 2016Feb 2031

Study Start

First participant enrolled

February 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

15 years

First QC Date

February 29, 2016

Last Update Submit

June 24, 2025

Conditions

DepressionStressConflict Resolution

Outcome Measures

Primary Outcomes (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

    Five years

Secondary Outcomes (1)

  • Participant reports of the acceptability of the PATH program

    Five years.

Other Outcomes (2)

  • Participant self-reported depression severity scores on the PHQ-9.

    Five years

  • Participant self-reported stress severity scores on the PSS

    Five years

Study Arms (1)

Internet Based psychological support

EXPERIMENTAL

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

Behavioral: Internet-based psychological support

Interventions

Internet-based psychological supportBEHAVIORAL

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.

Also known as: PATH
Internet Based psychological support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 28390503BACKGROUND

  • 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.

    PMID: 24680231BACKGROUND

  • 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.

    PMID: 23262118BACKGROUND

  • 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.

    PMID: 27779949BACKGROUND

  • 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.

    PMID: 33973856DERIVED

Related Links

MeSH Terms

Conditions

DepressionNegotiating

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorCommunication

Study Officials

  • Jay C Buckey, M.D.

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasiya Kobrina

CONTACT

603-646-5331anastasiya.kobrina@dartmouth.edu

Samantha M Leigh, B.S.

CONTACT

540-819-5715samantha.m.leigh@dartmouth.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 29, 2016

First Posted

April 1, 2016

Study Start

February 1, 2016

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2031

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)