NCT02761681

Brief Summary

This study will develop and then test a web-based guided self-help version of Acceptance and Commitment Therapy (ACT) to be utilized at college counseling centers (CCCs). ACT is an evidence-based transdiagnostic therapy found to effectively treat a range of psychological problems. An ACT program would provide a means of implementing effective treatment for the range of problems in the CCC setting, while the guided self-help format would reduce counselors' workload, improving cost-effectiveness and reducing waiting lists. This would both treat students and train counselors in how to implement the ACT intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 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

Study Start

First participant enrolled

April 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 year until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

4 years

First QC Date

April 30, 2015

Last Update Submit

July 25, 2019

Conditions

Mental Health

Keywords

Acceptance and Commitment TherapyMindfulnessGuided self-helpCollege studentsFocused InterviewsRCT Control ConditionRCT ACT-CL Condition

Outcome Measures

Primary Outcomes (1)

  • Change in Mental Health Symptoms - Counseling Center Assessment of Psychological Symptoms-62

    (Student Data) We will assess the change in various diagnoses and presentations common in college students (such as depression, anxiety, eating disorders, substance abuse, etc). This will be our primary outcome measure for students.

    Baseline (week 1), Post (week 8), Follow-up (week 16)

Secondary Outcomes (11)

  • System Usability Scale

    Post (week 8 or week 20)

  • ACT Knowledge Questionnaire

    Baseline (week 1) and post (week 20)

  • Counselor Implementation Questions

    Post (week 20)

  • Personal Values Questionnaire

    Baseline (week 1), Post (week 8) and Follow-up (week 16)

  • Satisfaction with Life Scale

    Baseline (week 1), Post (week 8) and Follow-up (week 16)

  • +6 more secondary outcomes

Study Arms (2)

ACT-CL Web-based guided self-help

EXPERIMENTAL

Behavioral: Experimental Web-based guided self-help Program This intervention will involve counselor training and student use of the developed program. Counselors will complete training and invite students to participate, and will monitor and guide students in completing the series of 8 web-based sessions based on Acceptance and Commitment Therapy.

Behavioral: ACT-CL Web-based guided self-help

Control Web-based guided self-help

ACTIVE COMPARATOR

Behavioral: Control Web-based guided self-help program This intervention will be created for the current study. It will involve psycho-education on how students might get the most out of counseling. Counselors will go through the psycho-education session before inviting students to participate.

Behavioral: Control Web-based guided self-help

Interventions

ACT-CL Web-based guided self-helpBEHAVIORAL
ACT-CL Web-based guided self-help
Control Web-based guided self-helpBEHAVIORAL
Control Web-based guided self-help

Eligibility Criteria

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

You may qualify if:

  • (Stage 1a: Counselor Focused Interviews): Currently working at CCC or previously worked at CCC for more than 1 year
  • (Stage 1a: Counselor Focused Interviews): Willing to spend approximately 9 hours across 5-7 phone or web conferences discussing elements and content of the web-based program as modules are developed
  • (Stage 1a: Counselor Focused Interviews): Participation will comply with targeted enrollment plans
  • (Stage 1b: Student Focused Interviews): Currently being treated at a local CCC, and seen by a counselor for a minimum of 4 sessions.
  • (Stage 1b: Student Focused Interviews): Between the ages of 18-25
  • (Stage 1b: Student Focused Interviews): Willing to spend approximately 10 hours across 8-12 phone or web conference sessions discussing elements of content of the web-based, guided self-help program as modules are developed.
  • (Stage 1b: Student Focused Interviews): Student is currently not suicidal or homicidal, and does not have a history of psychosis
  • (Stage 1b: Student Focused Interviews): Participation will comply with targeted enrollment plans, which also include adequate representation of participants across various clinical presentations
  • (Stage 1c: Director Focused Interviews): Currently working at a CCC as a director, or previously worked at a CCC as a director for more than 1 year
  • (Stage 1b: Student Focused Interviews): Willing to spend approximately 9 hours across 5-7 phone or web conference sessions discussing elements and content of the web-based, guided self help program as modules are developed.
  • (Stage 1b: Student Focused Interviews): Participation will comply with targeted enrollment plans.
  • (Stage 2a: Counselor RCT): Currently working at a CCC that received internal/local IRB approval for this study
  • (Stage 2a: Counselor RCT): Willingness to be randomized to either ACT+TAU or a Psychoeducation+TAU condition
  • (Stage 2a: Counselor RCT): If randomized to ACT+TAU, willingness to take the ACT guided self-help training during the 4 weeks prior to the start of the Fall 2016 semester, until reaching a passing criterion of 80% (which will take approximately 9 hours)
  • (Stage 2a: Counselor RCT): Willingness to attempt to recruit 10 student clients to participate either in the ACT self-help modules (if counselor is in ACT+TAU condition) or in the psychoeducation website (if counselor is in Psychoeducation+TAU)
  • +7 more criteria

You may not qualify if:

  • (Stage 1a: Counselor Focused Interviews): Very uncomfortable with technology (Scoring 0-1 on a 0-5 Likert-like scale on comfort with web-based presentations)
  • (Stage 1b: Student Focused Interviews): Under 18 years old
  • (Stage 1b: Student Focused Interviews): Lack of fluency in English at the 7th grade level
  • (Stage 1c: Director Focused Interviews): Very uncomfortable with technology (Scoring 0-1 on a 0-5 Likert-like scale on comfort with web-based presentations)
  • (Stage 2a: Counselor RCT): None
  • (Stage 2b: Student Program Evaluation): Under 18 years old
  • (Stage 2b: Student Program Evaluation): Lack of fluency in English at the 7th grade level.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contextual Change, LLC

Reno, Nevada, 89519, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Jacqueline Pistorello

    Contextual Change LLC

    PRINCIPAL INVESTIGATOR

  • Michael Levin

    Contextual Change LLC

    PRINCIPAL INVESTIGATOR

  • Crissa Levin

    Contextual Change LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 4, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2019

Study Completion

June 1, 2019

Last Updated

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)