Major Depressive DisorderNCT06700902
Taking Action for College Students
A study testing Taking Action in people with Major Depressive Disorder and Bipolar Disorder, run by Temple University at 1 site in United States.
Trial summary
The goal of this research is to investigate whether a peer-delivered illness self-management program called Taking Action can help college students with serious mental illnesses. Participants will be randomly assigned to either the experimental condition (Taking Action) or the control condition (information only). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- What is being tested?
- Taking Action
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently enrolled in a 2- or 4-year postsecondary educational institution in the United States (and are able to present a valid student ID card)
- Experiencing a serious mental illness, as operationalized by either:
- A score of 13 or higher on the K-6 Screening Scale for serious mental illness
- Self-reported psychiatric diagnosis of schizophrenia-spectrum or major affective disorder and self-reported lifetime functional impairment due to experiencing mental health challenges
- 18 years of age or older
- Have consistent access to a computer or smartphone and the Internet for communications
- No prior WRAP or Taking Action education
Who cannot join
- Expected to graduate or complete their program within 2 semesters
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19122
About this study
Official title: A Randomized Controlled Trial of Taking Action Planning for College Students With Serious Mental Illnesses
The goal of this research is to investigate whether a peer-delivered illness self-management program called Taking Action can help college students with serious mental illnesses. Participants will be randomly assigned to either the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions. Participants will complete three interviews (baseline, post-intervention, and follow-up) to assess how well the program works, is liked, and benefits students clinically and academically. The investigators seek to test the following hypotheses: Compared to controls, students who do the Taking Action program will report greater improvements in mental health self-management attitudes, skills, and behaviors and will report greater improvements in mental health symptoms and recovery, and better academic outcomes.
Read the detailed description
The purpose of this study is to assess the feasibility, acceptability, and effectiveness associated with Taking Action for college students with serious mental illnesses (SMI). The study will be a randomized controlled trial. The investigators plan to recruit 300 college students with SMI to participate in the study. A total of 60 students will be enrolled in the study per semester, 30 of whom will be randomized to Taking Action and 30 to the control condition. Enrollment will occur over a period of 5 semesters, with two Taking Action groups running concurrently each semester. The investigators will recruit from within Temple University and other colleges and universities in the United States.
Participants will be randomly assigned to one of two groups, the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions that will be delivered in a small group format online via videoconferencing.
All participants will complete 3 research interviews: baseline, post-intervention and follow-up, lasting about 1.5 hours each. Data related to the feasibility of research and intervention procedures, acceptability of the intervention, and clinical and academic outcomes will be collected and analyzed. The investigators will assess the feasibility of the intervention procedures by tracking data pertaining to recruitment, retention, and assessment using CONSORT guidelines, and data related to implementation of the intervention (i.e., fidelity, number of intervention meetings attended by participant). Fidelity to Taking Action will be assessed using a facilitator checklist based on prescribed content, procedures, and materials for each Taking Action session. Facilitators will also maintain attendance logs in RedCAP for each Taking Action session. The investigators will assess the acceptability of the intervention via quantitative and qualitative questions administered at post-intervention about participants' level of satisfaction and experiences with the intervention. The investigators will assess the clinical and academic outcomes of the intervention using the Mechanisms of Action Scale, Hopkins Symptom Checklist, Recovery Assessment Scale, College Persistence Questionnaire, Perceived Competence Scale, College Self-Efficacy Inventory, Study Habits Inventory, and Procrastination Assessment Scale - Students. Some exploratory measures will also be included in the interviews.
Feasibility and quantitative acceptability data will be reported using descriptive statistics. Qualitative acceptability data will be analyzed using thematic analysis. To examine the impact of Taking Action on mental health and academic outcomes random effect ANOVAs on repeated measures data in PROC MIXES (SAS) will be used to compare the experimental and control groups over time on the various measures. Prior to running the random effects ANOVAs above, the investigators will examine whether the experimental and control groups were different at baseline on any background characteristics despite randomization, and if so, control for them in the analyses. In addition, exploratory analyses will be conducted to provide insight regarding the characteristics of students who are most likely to benefit from Taking Action.
The investigators will recruit 300 individuals, which, with an estimated attrition rate of 25% based on previous experience with this population, will yield a sample of 225 participants with complete data. In a repeated measures ANOVA with two groups, three time points, and the correlation between repeated measures assumed to be 0.5, the investigators will be able to achieve .80 power to detect a small effect size of f=.085 in a time*group interaction term when the probability of a type I error, alpha, is set at .05. Even so, the investigators anticipate these power estimates are conservative, because of the use of PROC MIXED in SAS for analyzing repeated measures data. PROC MIXED does not discard participants with missing data at some time points, making the impact of missing data and attrition on power much less severe. GPower was used for power analysis.
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- Being tested
- Taking Action
- Keywords
- Taking Action, Recovery, Wellness, Serious Mental Illness, College Students
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking ActionBehavioural
Participants in the experimental condition will participate in the Taking Action intervention, which will be delivered in a small group format in 5 weekly 2.5 hour videoconferencing sessions. Taking Action will be implemented using materials available on SAMHSA's website (https://www.co.ozaukee.wi.us/DocumentCenter/View/8198/Taking-Action-A-MH-Recovery-Self-Help-Ed-Program?bidId=). The process will include an overview of key recovery and wellness concepts and the development of an individualized wellness toolbox, which is a list of skills and strategies that a person already uses or would like to use to maintain or regain wellness. Then, participants will make plans for monitoring and addressing distressing mental health symptoms. Instructional techniques will include lectures, discussions, personal examples from facilitators and participants own lives to illustrate key concepts related to self-management, individual and group exercises, and voluntary action plans between meetings.
| Study group | Role | What they receive |
|---|---|---|
| Taking Action Intervention Condition | Experimental | Participants in the experimental condition will participate in the Taking Action intervention. Receives: Behavioral: Taking Action |
| Information Only Control Condition | No intervention | Participants in the information only control condition will not participate in any intervention but will be given access to a resource entitled, "A Practical Guide for People with Disabilities Who Want to Go to College". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in Mental Health Symptoms
The Brief Symptom Inventory is a validated instrument used to assess mental health symptoms. The mean T-score is 50, with higher scores indicating worse outcome.
Change = (3-Month Follow-Up Score - Baseline Score).
Measured: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Perceived Recovery
The Recovery Assessment Scale is a validated instrument used to assess perceived recovery from mental illness. Scores range from 1 to 5 with higher scores indicating greater perceived recovery.
Change = (3-Month Follow-Up Score - Baseline Score).
Measured: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Secondary outcomes (5)
Changes from Baseline in Intention to Persist in College
The College Persistence Questionnaire is a validated instrument used to assess intention to persist in school. Scores range from -16 to +16 with higher scores indicating greater intention to persist in school.
Change = (3-Month Follow-Up Score - Baseline Score).
Measured: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Perceived Competence in Educational Environment
The Perceived Competence Scale is a validated instrument used to assess perceived competence that will be applied to an educational environment by asking how true items are \"with respect to your learning in your school courses.\" Scores range from 1-7, with higher scores indicating greater perceived competence.
Change = (3-Month Follow-Up Score - Baseline Score).
Measured: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Study Habits
The Study Habits Inventory is a validated instrument used to assess study habits. Scores range from 1 to 7 with higher scores indicating better study habits.
Change = (3-Month Follow-Up Score - Baseline Score).
Measured: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Procrastination
The Procrastination Assessment Scale - Students is a validated measure used assess procrastination. Scores range from 1 to 5 with higher scores indicating greater procrastination.
Change = (3-Month Follow-Up Score - Baseline Score).
Measured: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Change from Baseline in College Self-Efficacy
The College Self-Efficacy Inventory is a validated measure that assesses perceived self-efficacy in a college context. Scores range from 1 to 10 with higher scores indicating a better outcome. Change = (3-Month Follow-Up Score - Baseline Score).
Measured: Baseline, Immediately After the Intervention, 3 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Sep 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- A total of 60 students will be enrolled in the study per semester, 30 of whom will be randomized to Taking Action and 30 to the control condition. Enrollment will occur over a period of 5 semesters, with two Taking Action groups running concurrently each semester. Randomization will occur at the participant-level and will be facilitated by using an HIPAA-compliant, Internet-based randomization service (studyrandomizer.com). The research assistant, who will be blind to the random allocation sequence, will enter participants into the randomization service after completion of the baseline interview and notify them of the condition to which they are assigned.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700902
- Sponsor's protocol ID
- 31680
- Status last verified
- Dec 2025
- First submitted
- 30 Aug 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Taking Action Planning for College Students With Serious Mental Illnesses
- ClinicalTrials.gov ID
- NCT06700902
- Acronym / sponsor ID
- 31680
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Schizophrenia
- Keywords
- Taking Action, Recovery, Wellness, Serious Mental Illness, College Students
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Nov 2024 (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.
The goal of this research is to investigate whether a peer-delivered illness self-management program called Taking Action can help college students with serious mental illnesses. Participants will be randomly assigned to either the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions. Participants will complete three interviews (baseline, post-intervention, and follow-up) to assess how well the program works, is liked, and benefits students clinically and academically. The investigators seek to test the following hypotheses: Compared to controls, students who do the Taking Action program will report greater improvements in mental health self-management attitudes, skills, and behaviors and will report greater improvements in mental health symptoms and recovery, and better academic outcomes.
Detailed description
The purpose of this study is to assess the feasibility, acceptability, and effectiveness associated with Taking Action for college students with serious mental illnesses (SMI). The study will be a randomized controlled trial. The investigators plan to recruit 300 college students with SMI to participate in the study. A total of 60 students will be enrolled in the study per semester, 30 of whom will be randomized to Taking Action and 30 to the control condition. Enrollment will occur over a period of 5 semesters, with two Taking Action groups running concurrently each semester. The investigators will recruit from within Temple University and other colleges and universities in the United States.
Participants will be randomly assigned to one of two groups, the experimental condition (Taking Action) or the control condition (information only). Participants in the experimental condition will attend five 2.5-hour Taking Action sessions that will be delivered in a small group format online via videoconferencing.
All participants will complete 3 research interviews: baseline, post-intervention and follow-up, lasting about 1.5 hours each. Data related to the feasibility of research and intervention procedures, acceptability of the intervention, and clinical and academic outcomes will be collected and analyzed. The investigators will assess the feasibility of the intervention procedures by tracking data pertaining to recruitment, retention, and assessment using CONSORT guidelines, and data related to implementation of the intervention (i.e., fidelity, number of intervention meetings attended by participant). Fidelity to Taking Action will be assessed using a facilitator checklist based on prescribed content, procedures, and materials for each Taking Action session. Facilitators will also maintain attendance logs in RedCAP for each Taking Action session. The investigators will assess the acceptability of the intervention via quantitative and qualitative questions administered at post-intervention about participants' level of satisfaction and experiences with the intervention. The investigators will assess the clinical and academic outcomes of the intervention using the Mechanisms of Action Scale, Hopkins Symptom Checklist, Recovery Assessment Scale, College Persistence Questionnaire, Perceived Competence Scale, College Self-Efficacy Inventory, Study Habits Inventory, and Procrastination Assessment Scale - Students. Some exploratory measures will also be included in the interviews.
Feasibility and quantitative acceptability data will be reported using descriptive statistics. Qualitative acceptability data will be analyzed using thematic analysis. To examine the impact of Taking Action on mental health and academic outcomes random effect ANOVAs on repeated measures data in PROC MIXES (SAS) will be used to compare the experimental and control groups over time on the various measures. Prior to running the random effects ANOVAs above, the investigators will examine whether the experimental and control groups were different at baseline on any background characteristics despite randomization, and if so, control for them in the analyses. In addition, exploratory analyses will be conducted to provide insight regarding the characteristics of students who are most likely to benefit from Taking Action.
The investigators will recruit 300 individuals, which, with an estimated attrition rate of 25% based on previous experience with this population, will yield a sample of 225 participants with complete data. In a repeated measures ANOVA with two groups, three time points, and the correlation between repeated measures assumed to be 0.5, the investigators will be able to achieve .80 power to detect a small effect size of f=.085 in a time*group interaction term when the probability of a type I error, alpha, is set at .05. Even so, the investigators anticipate these power estimates are conservative, because of the use of PROC MIXED in SAS for analyzing repeated measures data. PROC MIXED does not discard participants with missing data at some time points, making the impact of missing data and attrition on power much less severe. GPower was used for power analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 60 students will be enrolled in the study per semester, 30 of whom will be randomized to Taking Action and 30 to the control condition. Enrollment will occur over a period of 5 semesters, with two Taking Action groups running concurrently each semester. Randomization will occur at the participant-level and will be facilitated by using an HIPAA-compliant, Internet-based randomization service (studyrandomizer.com). The research assistant, who will be blind to the random allocation sequence, will enter participants into the randomization service after completion of the baseline interview and notify them of the condition to which they are assigned.
| Arm | Type | Receives |
|---|---|---|
| Taking Action Intervention Condition | Experimental | Behavioral: Taking ActionParticipants in the experimental condition will participate in the Taking Action intervention. |
| Information Only Control Condition | No intervention | –Participants in the information only control condition will not participate in any intervention but will be given access to a resource entitled, "A Practical Guide for People with Disabilities Who Want to Go to College". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Currently enrolled in a 2- or 4-year postsecondary educational institution in the United States (and are able to present a valid student ID card)
- Experiencing a serious mental illness, as operationalized by either:
- A score of 13 or higher on the K-6 Screening Scale for serious mental illness
- Self-reported psychiatric diagnosis of schizophrenia-spectrum or major affective disorder and self-reported lifetime functional impairment due to experiencing mental health challenges
- 18 years of age or older
Key exclusion criteria (2 listed)
- Expected to graduate or complete their program within 2 semesters
- Unable to provide informed consent
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 |
|---|---|---|
| Taking ActionParticipants in the experimental condition will participate in the Taking Action intervention, which will be delivered in a small group format in 5 weekly 2.5 hour videoconferencing sessions. Taking Action will be implemented using materials available on SAMHSA's website (https://www.co.ozaukee.wi.us/DocumentCenter/View/8198/Taking-Action-A-MH-Recovery-Self-Help-Ed-Program?bidId=). The process will include an overview of key recovery and wellness concepts and the development of an individualized wellness toolbox, which is a list of skills and strategies that a person already uses or would like to use to maintain or regain wellness. Then, participants will make plans for monitoring and addressing distressing mental health symptoms. Instructional techniques will include lectures, discussions, personal examples from facilitators and participants own lives to illustrate key concepts related to self-management, individual and group exercises, and voluntary action plans between meetings. | Behavioural | Taking Action Intervention Condition |
Primary outcome
Changes from Baseline in Mental Health Symptoms
Time frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
The Brief Symptom Inventory is a validated instrument used to assess mental health symptoms. The mean T-score is 50, with higher scores indicating worse outcome. Change = (3-Month Follow-Up Score - Baseline Score).
Changes from Baseline in Perceived Recovery
Time frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
The Recovery Assessment Scale is a validated instrument used to assess perceived recovery from mental illness. Scores range from 1 to 5 with higher scores indicating greater perceived recovery. Change = (3-Month Follow-Up Score - Baseline Score).
5 secondary outcomes
Changes from Baseline in Intention to Persist in College
Time frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Perceived Competence in Educational Environment
Time frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Study Habits
Time frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Changes from Baseline in Procrastination
Time frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up
Change from Baseline in College Self-Efficacy
Time frame: Baseline, Immediately After the Intervention, 3 Month Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taking Action in people with Major Depressive Disorder and Bipolar Disorder, run by Temple 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Thomas, PhD (2152041699, elizabeth.thomas@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in Mental Health Symptoms (time frame: Baseline, Immediately After the Intervention, and 3-Month Follow-Up). 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?
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 Dec 2025.