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

NCT04810988 | Completed

• 1 other identifier: 2021-0292
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Anxiety; Mood

Keywords

depression; anxiety; mood; mood disorder; digital health; mHealth; unified protocol; pilot study

Outcome Measures

Primary Outcomes (6)

• Change Between Baseline and Post-Treatment System Usability Scale Score

  10-item, validated self-report user experience survey for digital systems answered on a five-point Likert scale

  through study completion, an average of 12 weeks

• Weekly Change in Willingness to Refer

  yes/no question if participants would recommend the intervention to others

  through study completion, an average of 12 weeks

• Total Number of Referrals (Sum Score)

  pts who select yes for willingness to refer will be given option to actually make referrals. this will calculate a sum score of total number of referrals

  through study completion, an average of 12 weeks

• Change in Cognitive Flexibility Inventory Score

  20-item measure of cognitive flexibility designed to be used for repeated measures over the course of an intervention

  through study completion, an average of 12 weeks

• Change in Cognitive and Affective Mindfulness Scale-Revised Score

  10-item questionnaire that assesses mindfulness of thoughts and emotions

  through study completion, an average of 12 weeks

• Change in COPE Inventory - Avoidance Factor Score

  COPE Inventory is a survey of coping strategies with 60-items split across 15 4-item scales; factor analysis has identified a 16-item avoidance factor, comprising 4 4-item subscales (mental disengagement, denial, behavioral disengagement, and substance use) which will be used for this study as the remaining items on the full COPE Inventory are not related to primary mechanisms of change in this intervention

  through study completion, an average of 12 weeks

Secondary Outcomes (2)

• Change in Overall Depression Severity and Impairment Scale Score

  through study completion, an average of 12 weeks

• Change in Overall Anxiety Severity and Impairment Scale Score

  through study completion, an average of 12 weeks

Study Arms (2)

Unsupported

ACTIVE COMPARATOR

Participants in this arm will receive a 12-week Unified Protocol intervention delivered via the same web platform. Each week, participants will complete the following content: 1. depression survey, 2. anxiety survey, 3. information about their symptom change over time, 4. psychoeducational text 5. practice exercises, 6. home practice instructions, 7. writing exercise, 8. home practice worksheets. In the first week, participants will receive an emailed welcome message followed by a link to the first week's content. For every following week, participants will receive an email at the start of the week with automatically generated feedback on intervention usage, behavior change, and symptom change, as well as the link to the new week's intervention content.

Behavioral: Unified Protocol

Partially Supported

EXPERIMENTAL

Participants in the partially supported arm will receive all aspects of the intervention described above, with no differences between arms for the first seven weeks of the intervention (Modules 1-6). Participants will be introduced to their study therapist in week 8, at the start of Module 7 via email. During Module 7 (exposure; weeks 8-11), participants will receive four video therapy sessions. Session content will be based on principles of exposure therapy (developing a personalized exposure hierarchy, live demonstrations of exposure exercises, in-session exposure practices, post-exposure processing, home practice assignments, and therapist feedback).

Behavioral: Unified Protocol; Behavioral: Therapist Support

Interventions

Unified Protocol BEHAVIORAL

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.

Also known as: Hazel

Partially Supported; Unsupported

Therapist Support BEHAVIORAL

4 video calls with study therapists

Partially Supported

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• Fluent in reading and writing English
• Internet/data plan and computer/tablet/phone access for length of study
• Overall Depression Severity and Impairment Scale (ODSIS) and/or Overall Anxiety Severity and Impairment Scale (OASIS) summary score \>= 8
• Live in North Carolina for the duration of the study

You may not qualify if:

• Educational attainment greater than high school diploma/equivalent
• Currently receiving other psychotherapy or planning to receive other psychotherapy during course of intervention
• \>=8 sessions of cognitive-behavioral therapy in past 12 months
• Currently taking psychiatric medications or planning to take psychiatric medications during course of intervention
• Current suicidality, operationalized as a positive result on the Ask Suicide-Screening Questions (ASQ) Tool
• Self-harm in past 12 months
• Current psychosis, as measured by Mini International Neuropsychiatric Interview Subsection K. Psychotic Disorders
• Substance abuse (other than nicotine, cannabis or caffeine) in the past 12 months, as measured by Structured Clinical Interview for The Diagnostic and Statistical Manual of Mental Disorders-5 substance use disorders subsection (past 12 months only)
• BMI \<= 18.5

Sponsors & Collaborators

• Duke University: lead
• Charles Lafitte Foundation: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Mood Disorders

Interventions

Cor a I protein, hazel

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Jack Brooks, MA

  Duke University

  STUDY DIRECTOR

• Gary G Bennett, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Neither participants nor study therapists will be blinded to participant condition, as it is not feasible to blind to whether or not someone is receiving therapist support.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: Eligible, consented participants will be immediately randomized to one of two arms and remain in that arm for the duration of the study.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 23, 2021
• Study Start: April 7, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)