- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573465
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
236
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.).
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.
|
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.
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.
|
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
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
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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
- Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
- Boss L, Lehr D, Reis D, Vis C, Riper H, Berking M, Ebert DD. Reliability and Validity of Assessing User Satisfaction With Web-Based Health Interventions. J Med Internet Res. 2016 Aug 31;18(8):e234. doi: 10.2196/jmir.5952.
- Francis A, Dawson D, Golijani-Moghaddam N. The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science. 2016; 5(3): 134-145.
- Keyes CL. Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psychol. 2005 Jun;73(3):539-48. doi: 10.1037/0022-006X.73.3.539.
- Osman A, Wong JL, Bagge CL, Freedenthal S, Gutierrez PM, Lozano G. The Depression Anxiety Stress Scales-21 (DASS-21): further examination of dimensions, scale reliability, and correlates. J Clin Psychol. 2012 Dec;68(12):1322-38. doi: 10.1002/jclp.21908. Epub 2012 Aug 28.
- Levin ME, Krafft J, Hicks ET, Pierce B, Twohig MP. A randomized dismantling trial of the open and engaged components of acceptance and commitment therapy in an online intervention for distressed college students. Behav Res Ther. 2020 Mar;126:103557. doi: 10.1016/j.brat.2020.103557. Epub 2020 Jan 22.
- Levin ME, Haeger JA, Pierce BG, Twohig MP. Web-Based Acceptance and Commitment Therapy for Mental Health Problems in College Students: A Randomized Controlled Trial. Behav Modif. 2017 Jan 1;41(1):141-162. doi: 10.1177/0145445516659645. Epub 2016 Jul 20.
- Shelef K, Diamond GM. Short form of the revised Vanderbilt therapeutic alliance scale: development, reliability, and validity. Psychother Res. 2008 Jul;18(4):433-43. doi: 10.1080/10503300701810801.
- Shim M, Mahaffey B, Bleidistel M, Gonzalez A. A scoping review of human-support factors in the context of Internet-based psychological interventions (IPIs) for depression and anxiety disorders. Clin Psychol Rev. 2017 Nov;57:129-140. doi: 10.1016/j.cpr.2017.09.003. Epub 2017 Sep 12.
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)
September 28, 2020
Primary Completion (ACTUAL)
June 24, 2021
Study Completion (ACTUAL)
July 5, 2021
Study Registration Dates
First Submitted
September 27, 2020
First Submitted That Met QC Criteria
September 27, 2020
First Posted (ACTUAL)
October 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 29, 2021
Last Update Submitted That Met QC Criteria
September 28, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID 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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