Treatment AdherenceNCT04573465
Pilot Evaluation of Peer-support Coaching to Increase Adherence to Online Self-help for College Mental Health
A study testing Phone Coaching, Text Message Coaching and ACT Guide in people with Treatment Adherence, run by Utah State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Treatment Adherence
- What is being tested?
- Phone Coaching, Text Message Coaching and ACT Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- USU undergraduate student
- Fluent in English
Who cannot join
- Must have not used ACT Guide in the past
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Treatment Adherence
- Being tested
- Phone Coaching, Text Message Coaching, ACT Guide
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone CoachingBehavioural
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.).
Text Message CoachingBehavioural
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).
ACT GuideBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Phone Coaching; Behavioral: 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. Receives: Behavioral: Text Message Coaching; Behavioral: 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. Receives: Behavioral: ACT Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: After completion of first contact with coach and post-treatment (10 weeks after baseline)
Mental Health Continuum Short Form (MHC-SF; Keyes, 2005)
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.
Measured: Post-treatment (10 weeks after baseline)
The Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011)
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.
Measured: Post-treatment (10 weeks after baseline)
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT; Francis, Dawson, & Golijani-Moghaddam, 2016)
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.
Measured: Post-treatment (10 weeks after baseline)
Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I; Boß et al., 2016)
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.
Measured: Post-treatment (10 weeks after baseline)
Novel user experience item 1
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.
Measured: Post-treatment (10 weeks after baseline)
Novel user experience item 2
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.
Measured: Post-treatment (10 weeks after baseline)
Novel user experience item 3
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.
Measured: Post-treatment (10 weeks after baseline)
Novel user experience item 4
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.
Measured: Post-treatment (10 weeks after baseline)
Novel user experience item 5
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.
Measured: Post-treatment (10 weeks after baseline)
Novel user experience item 6
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.
Measured: Post-treatment (10 weeks after baseline)
Novel user experience item 7
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.
Measured: Post-treatment (10 weeks after baseline)
Novel user experience item 8
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching experience item 1
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching experience item 2
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching experience item 3
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 1
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 2
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 3
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 4
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 1
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 2
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 3
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.
Measured: Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 4
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.
Measured: Post-treatment (10 weeks after baseline)
Phone coaching adherence
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.
Measured: Post-treatment (10 weeks after baseline)
Text coaching adherence
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.
Measured: Post-treatment (10 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start28 Sep 2020
- Primary completion24 Jun 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Treatment AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Levin, Utah State University
- Investigators
- Michael E Levin, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573465
- Sponsor's protocol ID
- 11308
- Status last verified
- Sep 2021
- First submitted
- 27 Sep 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27582341Bond 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.
PubMed 22035996Francis 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.
PubMed 15982151Osman 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.
PubMed 22930477Levin 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.
PubMed 32014692Levin 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.
PubMed 27440189Shelef 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.
PubMed 18815995Shim 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.
PubMed 28934623
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Peer-support Coaching to Increase Adherence to Online Self-help for College Mental Health
- ClinicalTrials.gov ID
- NCT04573465
- Acronym / sponsor ID
- 11308
- Conditions
- Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 24 Jun 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phone Coaching Condition | Experimental | Behavioral: Phone Coaching, Behavioral: ACT GuideParticipants 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. |
| Text Message Coaching Condition | Experimental | Behavioral: Text Message Coaching, Behavioral: ACT GuideParticipants 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. |
| No Coaching Condition | Active comparator | Behavioral: ACT GuideParticipants will be asked to use ACT Guide, an online program for general mental health, over the course of 10 weeks while receiving no coaching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- USU undergraduate student
- Fluent in English
Key exclusion criteria (1 listed)
- Must have not used ACT Guide in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone CoachingParticipants 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.). | Behavioural | Phone Coaching Condition |
| Text Message CoachingParticipants 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). | Behavioural | Text Message Coaching Condition |
| ACT GuideACT 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. | Behavioural | No Coaching Condition, Phone Coaching Condition, Text Message Coaching Condition |
Primary outcome
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.
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.
26 secondary outcomes
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)
Mental Health Continuum Short Form (MHC-SF; Keyes, 2005)
Time frame: 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)
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT; Francis, Dawson, & Golijani-Moghaddam, 2016)
Time frame: 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)
Novel user experience item 1
Time frame: Post-treatment (10 weeks after baseline)
Novel user experience item 2
Time frame: Post-treatment (10 weeks after baseline)
Novel user experience item 3
Time frame: Post-treatment (10 weeks after baseline)
Novel user experience item 4
Time frame: Post-treatment (10 weeks after baseline)
Novel user experience item 5
Time frame: Post-treatment (10 weeks after baseline)
Novel user experience item 6
Time frame: Post-treatment (10 weeks after baseline)
Novel user experience item 7
Time frame: Post-treatment (10 weeks after baseline)
Novel user experience item 8
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching experience item 1
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching experience item 2
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching experience item 3
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 1
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 2
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 3
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching acceptability item 4
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 1
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 2
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 3
Time frame: Post-treatment (10 weeks after baseline)
Novel coaching satisfaction item 4
Time frame: Post-treatment (10 weeks after baseline)
Phone coaching adherence
Time frame: Post-treatment (10 weeks after baseline)
Text coaching adherence
Time frame: Post-treatment (10 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 27582341Boss 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.
- Background: PubMed 22035996Bond 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.
- BackgroundFrancis 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: PubMed 15982151Keyes 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.
- Background: PubMed 22930477Osman 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.
- Background: PubMed 32014692Levin 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.
- Background: PubMed 27440189Levin 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.
- Background: PubMed 18815995Shelef 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.
- Background: PubMed 28934623Shim 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.
- Individual participant dataSharing planned: Undecided
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Surgical Site Infection
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Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.
Eating Disorders, Body Image Dissatisfaction
Not yet recruiting
Personalized Routine and Habit Integration to Support Medication Management
Medication Adherence
Not yet recruitingObservational study
Antipsychotic Safety and Adherence in Patients With Psychiatric Disorders-An Egyptian Institution-Based Cross-Sectional Study.
Psychiatric Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Levin, PhD principal investigator
Utah State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone Coaching, Text Message Coaching and ACT Guide in people with Treatment Adherence, run by Utah State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACT Guide Module Completion (time frame: Post-treatment (10 weeks after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573465, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.