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

NCT ID: NCT04810988

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2022-06-30

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.

Detailed Description

The study is a 12-week, randomized controlled trial ("Hazel") comparing an intervention for depression and anxiety symptoms with two different levels of support. Eligible participants will be randomized to receive: 1) a Unified Protocol intervention with 4 weeks of human support during exposure exercises in weeks 8-11 ("Partially Supported"); or 2) a Unified Protocol intervention without support at any point (the "Unsupported" arm). At 4 weeks post-intervention, participants will be sent a link to complete follow-up survey measures for depression and anxiety symptoms.

The Unified Protocol is an empirically supported, transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy.27 The Unified Protocol can be delivered in 12 to 18 weeks, with one one-hour session per week. Treatment focuses on increasing awareness of maladaptive thoughts and behaviors while decreasing avoidance of emotions and physiological sensations. Each week, patients receive psychoeducation, complete in-session practice exercises and self-monitor symptom change. At the end of each session, patients are assigned a home practice assignment to increase adaptive coping and generalize skill use outside of the therapy room.

Participants in both arms will receive a 12-week Unified Protocol intervention delivered via the same web platform (REDCap). The intervention will include all 8 modules of the Unified Protocol. Every week, participants will be directed to complete the following content:

1. depression symptom survey,

2. anxiety symptom survey,

3. information about their symptom change over time,

4. psychoeducational text

5. practice exercises,

6. home practice instructions,

7. writing exercise, and

8. home practice worksheet(s).

The symptom surveys, symptom graph and writing exercise will remain the same each week. The psychoeducational text, practice exercises and homework assignments will vary based on that week's topic. For the writing exercise, participants will be prompted to write notes on their take-aways, questions about the material, and ways they can incorporate the lesson into their upcoming week. The investigators will aim to write as much text as possible at a 5th grade reading level, based on evidence that 52% of US residents read English at a 5th-grade level or below.

Participants randomized to the unsupported arm will receive the intervention exactly as described above, with no additional components. Completion of all weeks will be entirely self- guided, to emulate a publicly available, standalone intervention.

Participants randomized to 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 in this arm will be introduced to their assigned study therapist in week 8, at the start of Module 7 via email. During Module 7 (exposure; weeks 8-11), participants in this arm will receive four video therapy sessions. These sessions will entail synchronous, video-call contact with their assigned study therapist, and session content will be based on principles of exposure therapy. The first session will entail developing a personalized exposure hierarchy, which will inform subsequent in-session and home practice assignments. In all sessions, study therapists will do live demonstrations of exposure exercises, monitor participants during exposure practice and provide feedback as clinically indicated, guide participants through post-exposure processing, and assign in-vivo exposure practices for homework. In the second through fourth sessions, study therapists will also review and provide feedback on participants' home practice.

Study therapists will be clinical psychology graduate students at Duke University and will be trained and supervised by Dr. Clair Robbins, a clinical associate at Duke and expert in the Unified Protocol. Dr. Robbins is expected to pass licensure exams during the Spring 2021 semester. Until then, umbrella supervision will be provided by Dr. M. Zach Rosenthal, a North Carolina-license psychologist and director of Duke's Cognitive Behavioral Research and Treatment Program.

On recruitment and participant materials, the study will be referred to by the name "Hazel." Hazel was chosen as a name because it is a relatively uncommon word that is both a name and a noun. The investigators' hope is that using a study title that can be a name will evoke a sense of warmth and personalization in the online intervention. At the same time, "Hazel" is not exclusively used a name, which the investigators hope will prevent undue confusion or misleading respondents into thinking Hazel is a human therapist. Finally, the investigators hope that its relatively uncommon usage will help prevent confusion with any other similar studies or programs. The name Hazel is incorporated into study materials in terms of color scheme and logo. At the end of the intervention, the hazelnut logo used throughout Hazel will be transformed into a hazelnut tree sprout, symbolizing both the ways participants have grown over the course of the intervention and the possibility for ongoing growth as they continue applying their new skills after the intervention period ends.

Conditions

Depression; Anxiety; Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unsupported

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.

Group Type: ACTIVE_COMPARATOR

Unified Protocol

Intervention Type: 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.

Partially Supported

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).

Group Type: EXPERIMENTAL

Unified Protocol

Intervention Type: 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.

Therapist Support

Intervention Type: BEHAVIORAL

4 video calls with study therapists

Interventions

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.

Intervention Type: BEHAVIORAL

Therapist Support

4 video calls with study therapists

Intervention Type: BEHAVIORAL

Other Intervention Names

Hazel

Eligibility Criteria

Inclusion Criteria

• 18+ 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles Lafitte Foundation

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Heather Parnell

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jack Brooks, MA

Role: STUDY_DIRECTOR

Duke University

Gary G Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Other Identifiers

2021-0292

Identifier Type: -

Identifier Source: org_study_id