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Internet Based Psychological Support

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor 5 versions Re-verified since Apr 16, 2022, no change to tracked fieldsv8-v12
  2. Notable Primary and study completion dates: Feb 2021 to Feb 2031v7
  3. Minor Publications: 4 to 5v6
  4. Minor Re-verified, no change to tracked fieldsv5
  5. Notable Primary endpoint revisedv4 Show 7 more changesShow less
    • Interventions: Computer Based PST (Behavioral) to Internet-based psychological support (Behavioral)
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoint revised
    • Study description expanded, about 556 words
    • Site contact updated
    • Publications: 1 to 4
    • Study title shortened, about 10 words
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Site contact updatedv3
  2. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT02726061
Lead Sponsor Dartmouth-Hitchcock Medical Center
Conditions
(from sponsor)
Depression, Stress, Conflict Resolution
Related terms Depression, Negotiating
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov