Clinical trial NCT04573465: Pilot Evaluation of Peer-support Coaching to Increase Adherence to Online Self-help for College Mental Health
Official title: Pilot Evaluation of Peer-support Coaching to Increase Adherence to Online Self-help for College Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Adherence
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned with equal likelihood to receive the online intervention with coaching delivered through weekly phone calls, the online intervention with coaching delivered through weekly text messages, or the online intervention with no coaching.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* USU undergraduate student
* Fluent in English

Exclusion Criteria:

* Must have not used ACT Guide in the past

Primary outcomes:
measure: ACT Guide Module Completion
timeFrame: Post-treatment (10 weeks after baseline)
measure: Depression, Anxiety, and Stress Scale (DASS-21; Osman et al., 2012)
timeFrame: Post-treatment (10 weeks after baseline)
Secondary outcomes:
measure: Short Form of the Revised Vanderbilt Therapeutic Alliance Scale adapted for coaching (VTAS-R; Shelef & Diamond, 2008)
timeFrame: After completion of first contact with coach and post-treatment (10 weeks after baseline)
measure: Mental Health Continuum Short Form (MHC-SF; Keyes, 2005)
timeFrame: Post-treatment (10 weeks after baseline)
measure: The Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011)
timeFrame: Post-treatment (10 weeks after baseline)
measure: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT; Francis, Dawson, & Golijani-Moghaddam, 2016)
timeFrame: Post-treatment (10 weeks after baseline)
measure: Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I; Boß et al., 2016)
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel user experience item 1
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel user experience item 2
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel user experience item 3
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel user experience item 4
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel user experience item 5
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel user experience item 6
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel user experience item 7
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel user experience item 8
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching experience item 1
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching experience item 2
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching experience item 3
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching acceptability item 1
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching acceptability item 2
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching acceptability item 3
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching acceptability item 4
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching satisfaction item 1
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching satisfaction item 2
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching satisfaction item 3
timeFrame: Post-treatment (10 weeks after baseline)
measure: Novel coaching satisfaction item 4
timeFrame: Post-treatment (10 weeks after baseline)
measure: Phone coaching adherence
timeFrame: Post-treatment (10 weeks after baseline)
measure: Text coaching adherence
timeFrame: Post-treatment (10 weeks after baseline)
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Michael E Levin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.