NCT04573465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

September 27, 2020

Last Update Submit

September 28, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • ACT Guide Module Completion

    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)

    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 Outcomes (26)

  • Short Form of the Revised Vanderbilt Therapeutic Alliance Scale adapted for coaching (VTAS-R; Shelef & Diamond, 2008)

    After completion of first contact with coach and post-treatment (10 weeks after baseline)

  • Mental Health Continuum Short Form (MHC-SF; Keyes, 2005)

    Post-treatment (10 weeks after baseline)

  • The Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011)

    Post-treatment (10 weeks after baseline)

  • Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT; Francis, Dawson, & Golijani-Moghaddam, 2016)

    Post-treatment (10 weeks after baseline)

  • Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I; Boß et al., 2016)

    Post-treatment (10 weeks after baseline)

  • +21 more secondary outcomes

Study Arms (3)

Phone Coaching Condition

EXPERIMENTAL

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 CoachingBehavioral: ACT Guide

Text Message Coaching Condition

EXPERIMENTAL

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: Text Message CoachingBehavioral: ACT Guide

No Coaching Condition

ACTIVE COMPARATOR

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

Interventions

Phone CoachingBEHAVIORAL

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.).

Phone Coaching Condition

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).

Text Message Coaching Condition
ACT GuideBEHAVIORAL

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.

No Coaching ConditionPhone Coaching ConditionText Message Coaching Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • USU undergraduate student
  • Fluent in English

You may not qualify if:

  • Must have not used ACT Guide in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (9)

  • 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.

    PMID: 27582341BACKGROUND
  • 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.

    PMID: 22035996BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 15982151BACKGROUND
  • 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.

    PMID: 22930477BACKGROUND
  • 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.

    PMID: 32014692BACKGROUND
  • 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.

    PMID: 27440189BACKGROUND
  • 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.

    PMID: 18815995BACKGROUND
  • 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.

    PMID: 28934623BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Michael E Levin, PhD

    Utah State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 5, 2020

Study Start

September 28, 2020

Primary Completion

June 24, 2021

Study Completion

July 5, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations