MedTrace Logo

Outcomes of a Self-guided Versus Therapist-guided Online Mental Health Treatment

NCT04810988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-07-22

No results posted yet for this study

Summary

This is a pilot study of an online mental health treatment. The goals of the study are to determine the feasibility of an online treatment for depression and anxiety symptoms with little-to-no human support, in a sample of 50 adults with limited educational attainment. The treatment is based on the Unified Protocol, an evidence-based treatment for mood and anxiety symptoms. The study will enroll participants on a rolling basis until reaching the goal of 50 participants. The intervention lasts 16 weeks, with 12 weeks of online treatment focused on increasing mindfulness, decreasing avoidance, and increasing cognitive flexibility in order to decrease depression and anxiety symptoms. Participants will complete surveys about their symptoms and how they feel about the treatment to help us establish the feasibility of a larger trial.

Conditions

Interventions

BEHAVIORAL

Unified Protocol

The Unified Protocol is an empirically supported, transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy. Treatment focuses on increasing awareness of maladaptive thoughts and behaviors and decreasing avoidance of emotions and physiological sensations. Module 1 is focused on increasing motivation, readiness and self-efficacy for change. Module 2 focuses on increasing understanding and awareness of emotions. Module 3 is focused on further expanding awareness of emotions. Module 4 focuses on the role of thoughts in emotional disorders. Module 5 is focused on the role of behaviors in emotional disorders. Module 6 focuses on the role of physical sensations in emotional disorders. Module 7 focuses on exposure to interoceptive and situational triggers for emotions. Module 8 is focused on maintenance of treatment progress and relapse prevention.

BEHAVIORAL

Therapist Support

4 video calls with study therapists

Sponsors & Collaborators

  • Charles Lafitte Foundation

    collaborator UNKNOWN

  • Duke University

    lead OTHER

Principal Investigators

  • Jack Brooks, MA · Duke University

  • Gary G Bennett, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04810988 on ClinicalTrials.gov