Pilot Evaluation of Peer-support Coaching to Increase Adherence to Online Self-help for College Mental Health

September 28, 2021 updated by: Michael Levin, Utah State University
This study aims to test if coaching can improve program adherence to an online mental health program in college students if delivered by undergraduate peers. Participants will be randomly assigned to either receive phone coaching, text message coaching, or no coaching. It is hypothesized that participants who receive phone coaching will exhibit greater adherence to the provided online mental health program than participants who receive text message coaching or no coaching.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to test the feasibility and effectiveness of an innovative peer support coaching model for college students. The primary aim of the coaching model is to increase participants' adherence to ACT Guide, an online mental health program. To test the effects of peer-support coaching on ACT Guide adherence rates and outcomes, the investigators will conduct a randomized controlled trial with three conditions (peer-support phone coaching, peer-support text message coaching, and a no support control group) using a sample of 300 Utah State University undergraduate students. Individuals who indicate interest in participating will complete an automated online workflow through Qualtrics which will include informed consent, baseline assessment, ACT Guide registration, and randomization into one of the three conditions. Participants will then gain access to a research version of ACT Guide, either with no additional support, with concurrent peer-support coaching, or with concurrent peer-support text messaging based on their randomly assigned condition. Coaching will take place over 10 weeks, with the post assessment being administered 10 weeks after baseline assessment. The investigators hypothesize that participants will adhere to coaching (80% completing ≥ 6 coaching calls; 80% responding to texts > 6 weeks), be satisfied with coaching (M = 5 "agree" on a 6-point self-reported coaching satisfaction scale), and that coaching fidelity will be maintained (80% of audited coaching calls/texts meeting criteria for fidelity). The investigators also hypothesize that participants who receive peer-support phone coaching will complete more ACT Guide modules and will report greater improvements in mental health relative to both the text messaging and no support conditions, and that the text messaging condition will perform greater in this regard than the no support condition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Logan, Utah, United States, 84322
        • Utah State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • USU undergraduate student
  • Fluent in English

Exclusion Criteria:

  • Must have not used ACT Guide in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Phone Coaching Condition
Participants will receive weekly, 10-15 minute phone coaching from a trained peer-support coach throughout the 10 weeks that they use ACT Guide, an online program for general mental health. Coaches will adhere to an ACT-based protocol that includes reinforcing adherence, identifying and problem solving non-adherence, strengthening and generalizing ACT skills, and using ACT skills to increase commitment to ongoing program adherence.
Behavioral: Phone Coaching
Participants receiving phone coaching receive one 10-15 minute phone call each week from their randomly assigned peer-support coach. During coaching calls, the peer-support coach will discuss ACT Guide usage with the participant (e.g., asking how many modules the participant completed, asking what the participant liked/disliked about the modules, etc.).
Behavioral: ACT Guide
ACT Guide is an online self-help program based on acceptance and commitment therapy (ACT), targeting acceptance, mindfulness, and values-based processes. It is intended to be used for 20 to 40 minutes at time, a few times a week. While using ACT Guide, participants will read about concepts relevant to ACT and engage in guided experiential exercises, with additional exercises being assigned to be completed in between sessions as homework.
EXPERIMENTAL: Text Message Coaching Condition
Participants assigned to the text messaging condition will receive weekly text messages from their peer-support coach throughout the 10 weeks that they use ACT Guide, an online program for general mental health. These text messages will reflect content delivered in the phone coaching group, but through a briefer protocol that accounts for the abbreviated, asynchronous nature of texting. Text messages will similarly focus on reinforcing adherence, problem solving non-adherence, strengthening ACT skills, and using ACT to increase program adherence. However, these areas will be covered in short messages and with limited exchanges between participants and coaches due to the asynchronous nature of texting.
Behavioral: ACT Guide
ACT Guide is an online self-help program based on acceptance and commitment therapy (ACT), targeting acceptance, mindfulness, and values-based processes. It is intended to be used for 20 to 40 minutes at time, a few times a week. While using ACT Guide, participants will read about concepts relevant to ACT and engage in guided experiential exercises, with additional exercises being assigned to be completed in between sessions as homework.
Behavioral: Text Message Coaching
Participants receiving text message coaching receive text messages on a weekly basis from their randomly assigned peer-support coach. Text messages from the peer-support coach will discuss ACT Guide usage with the participant (e.g., asking how many modules the participant completed).
ACTIVE_COMPARATOR: No Coaching Condition
Participants will be asked to use ACT Guide, an online program for general mental health, over the course of 10 weeks while receiving no coaching.
Behavioral: ACT Guide
ACT Guide is an online self-help program based on acceptance and commitment therapy (ACT), targeting acceptance, mindfulness, and values-based processes. It is intended to be used for 20 to 40 minutes at time, a few times a week. While using ACT Guide, participants will read about concepts relevant to ACT and engage in guided experiential exercises, with additional exercises being assigned to be completed in between sessions as homework.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ACT Guide Module Completion
Time Frame: Post-treatment (10 weeks after baseline)
Number of modules completed within ACT Guide, out of a total of 12 modules. This is automatically recorded within the ACT Guide program, and is not self-reported.
Post-treatment (10 weeks after baseline)
Depression, Anxiety, and Stress Scale (DASS-21; Osman et al., 2012)
Time Frame: Post-treatment (10 weeks after baseline)
A self-report measure for depression, anxiety, and stress . Items are rated on a 4-point Likert scale from 0 (did not apply to me at all) to 3 (applied to me most of the time), with a higher score indicating a worse outcome. Minimum total of 0 and maximum total of 63.
Post-treatment (10 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short Form of the Revised Vanderbilt Therapeutic Alliance Scale adapted for coaching (VTAS-R; Shelef & Diamond, 2008)
Time Frame: After completion of first contact with coach and post-treatment (10 weeks after baseline)
A self-report measure for therapeutic alliance, with modified wording in order to adapt to a coaching context. Only administered to participants in either coaching condition. Items are rates on a 6-point Likert scale from 0 (not at all) to 5 (a great deal), with a higher score indicating a better outcome. Minimum total of 0 and maximum total of 25.
After completion of first contact with coach and post-treatment (10 weeks after baseline)
Mental Health Continuum Short Form (MHC-SF; Keyes, 2005)
Time Frame: Post-treatment (10 weeks after baseline)
A self-report measure for positive mental health. Items are rated on a 6-point Likert scale from 1 (never) to 6 (every day), with a higher score indicating a better outcome. Minimum total of 14 and maximum total of 84.
Post-treatment (10 weeks after baseline)
The Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011)
Time Frame: Post-treatment (10 weeks after baseline)
A self-report measure for psychological flexibility. Items are rated on a 7-point Likert scale from 1 (never true) to 7 (always true), with a higher score indicating a worse outcome. Minimum total of 7 and maximum total of 49.
Post-treatment (10 weeks after baseline)
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT; Francis, Dawson, & Golijani-Moghaddam, 2016)
Time Frame: Post-treatment (10 weeks after baseline)
A self-report measure for psychological flexibility. Items are rated on a 7-point Likert scale from 0 (strongly disagree) to 6 (strongly agree), with a higher score indicating a better outcome. Minimum total of 0 and maximum total of 138.
Post-treatment (10 weeks after baseline)
Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I; Boß et al., 2016)
Time Frame: Post-treatment (10 weeks after baseline)
A self-report measure for program satisfaction. Items are rated on a 4-point Likert scale from 1 (does not apply to me) to 4 (does totally apply to me), with a higher score indicating a better outcome. Minimum total of 8 and a maximum total of 32.
Post-treatment (10 weeks after baseline)
Novel user experience item 1
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "Overall, I was motivated to use ACT Guide" This is a user experience item specific to this study.
Post-treatment (10 weeks after baseline)
Novel user experience item 2
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I had the support I needed to use ACT Guide." This is a novel user experience item specific to this study.
Post-treatment (10 weeks after baseline)
Novel user experience item 3
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I understood the concepts and skills presented in ACT Guide." This is a novel user experience item specific to this study.
Post-treatment (10 weeks after baseline)
Novel user experience item 4
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I was able to apply skills I learned in ACT Guide to my personal struggles and daily life." This is a novel user experience item specific to this study.
Post-treatment (10 weeks after baseline)
Novel user experience item 5
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I was able to identify and problem solve barriers to using ACT Guide." This is a novel user experience item specific to this study.
Post-treatment (10 weeks after baseline)
Novel user experience item 6
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "Many college students who struggle with mental health issues use self-help resources like ACT Guide for support." This is a novel user experience item specific to this study.
Post-treatment (10 weeks after baseline)
Novel user experience item 7
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "People would judge me negatively if they found out I was using ACT Guide." This is a novel user experience item specific to this study.
Post-treatment (10 weeks after baseline)
Novel user experience item 8
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "College students approve of the use of self-help resources like ACT Guide for addressing mental health issues." This is a novel user experience item specific to this study.
Post-treatment (10 weeks after baseline)
Novel coaching experience item 1
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I would have preferred using ACT Guide without a coach." This is a novel coaching experience item specific to this study. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching experience item 2
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "ACT Guide would have been just as helpful to me without a coach." This is a novel user experience item specific to this study. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching experience item 3
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate agreement from 1 (Strongly disagree) to 6 (Strongly agree) with the statement "I would have preferred to receive coaching from a mental health professional." This is a novel user experience item specific to this study. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 1
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate "Coaching through phone calls" on a scale from 1 (Unacceptable) to 5 (Strongly preferred). This is a novel coaching acceptability item specific to this study. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 2
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate "Coaching through text messaging" on a scale from 1 (Unacceptable) to 5 (Strongly preferred). This is a novel coaching acceptability item specific to this study. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 3
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate "Coaching through email" on a scale from 1 (Unacceptable) to 5 (Strongly preferred). This is a novel coaching acceptability item specific to this study. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 4
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked to rate "Coaching through videoconferencing software" on a scale from 1 (Unacceptable) to 5 (Strongly preferred). This is a novel coaching acceptability item specific to this study. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 1
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked "What was helpful about the coaching process?" to gather qualitative feedback on their respective coaching intervention. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 2
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked "What was unhelpful about the coaching process?" to gather qualitative feedback on their respective coaching intervention. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 3
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked "How did having another USU undergraduate be your coach affect the coaching process?" to gather qualitative feedback on their respective coaching intervention. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 4
Time Frame: Post-treatment (10 weeks after baseline)
Participants will be asked "How can the coaching process be improved in the future?" to gather qualitative feedback on their respective coaching intervention. Only administered to participants in either coaching condition.
Post-treatment (10 weeks after baseline)
Phone coaching adherence
Time Frame: Post-treatment (10 weeks after baseline)
Number of coaching calls answered, out of a total of 10 calls. This is based on coaches call logs, and is not self-reported. Only applicable to participants in the phone coaching condition.
Post-treatment (10 weeks after baseline)
Text coaching adherence
Time Frame: Post-treatment (10 weeks after baseline)
Number of initial coaching text messages responded to, out of a total of 10 initial text messages (one sent per week, not including text messages continuing a conversation stemming from an initial text message). This is based on coaches text message logs, and is not self-reported. Only applicable to participants in the text message coaching condition.
Post-treatment (10 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Utah State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael E Levin, PhD, Utah State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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