CAMPUS - Feasibility Sub-Study (CAMPUS-Feas)

Duke University

Status: Completed

Conditions: Suicide

Treatments: Behavioral: CAMS - Phase 2; Behavioral: DBT - Phase 1 and 2; Behavioral: DBT - Phase 2; Behavioral: TAU - Phase 1; Behavioral: CAMS - Phase 1

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04728815

R01MH116061 (U.S. NIH Grant/Contract)

R01MH116062 (U.S. NIH Grant/Contract)

R01MH116052 (U.S. NIH Grant/Contract)

Pro00103346

Pro00104815 (Other Identifier)

R01MH116050 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Suicide is the 2nd leading cause of death among college students and suicidal ideation and suicide-related behaviors are a frequent presenting problem at college counseling centers (CCCs), which are overburdened. Studies show that some students respond rapidly to treatment, whereas others require considerably more resources. Evidence-based adaptive treatment strategies (ATSs) are needed to address this heterogeneity in responsivity and complexity. ATSs individualize treatment via decision rules specifying how the type and intensity of an intervention can be sequenced based on risk factors, response, or compliance.

The purpose of this multisite study is to investigate the effectiveness of four adaptive treatment strategies (ATSs) to treat college students who report suicidal ideation when first seeking services at their college counseling center This multisite study will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. This Sequential Multi-Assignment Randomized Trial (SMART) will have two stages of intervention. In Stage 1, 700 participants from four CCCs will be randomized to 4-8 weeks of: 1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) or 2) Treatment as Usual (TAU). Sufficient responders to either intervention will discontinue services/be stepped down. Non-responders will be re-randomized to one of two Stage 2 higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT), which includes individual therapy, skills group, and phone/text coaching for the clients and peer consultation for the counselors.

Full description

We will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. Eighty-Five participants (N=85) from four CCCs will be randomized to one of three treatments delivered via a hybrid model: (1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks (n=35); (2) Treatment as Usual (TAU) for 4-8 weeks (n=15); or (3) Comprehensive Dialectical Behavior Therapy (DBT) for 16 weeks (n=35), which includes individual therapy, skills training, phone/text coaching for the clients, and peer consultation for the counselors.

Sufficient responders to CAMS or TAU will discontinue services/be stepped down after 4-8 weeks. Non-responders to CAMS or TAU will be re-randomized to one of two higher intensity/dosage intervention options for an additional 8 weeks of treatment: (1) CAMS (either continued or administered for the first time) or (2) Comprehensive DBT.

For the feasibility study, we will also enroll 12 CCC counselors (3 per site) who will serve as study counselor participants and periodically complete measures focused on the experience of counselors working with suicidal college students.

Enrollment: 84 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Enrolled at the university;
2. Eligible to receive counseling services either in person or remotely at the campus CCC (e.g., some students who are living in specific states may not be eligible for therapeutic services).
3. 18 to 25 years of age;
4. Moderate to severe SI over the last two weeks indicated by a score of greater than or equal to 2 on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34) question, "I have thoughts of ending my life" (range is 0 "not at all like me" to 4 "extremely like me"); and
5. Agree to video recording of all therapy and assessment sessions.

Exclusion criteria

1. Students who are deemed clinically inappropriate to receive services at the CCC by an intake counselor because of imminent risk, severe psychosis, or inability to remain enrolled in school (e.g., academic failure);
2. Students being unable to remain enrolled in their university long enough to go through the minimum number of sessions for Stage 1 (4 sessions);
3. Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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84 participants in 8 patient groups

CAMS to Maintenance

Experimental group

Description:

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.

Treatment:

Behavioral: CAMS - Phase 1

CAMS to CAMS

Experimental group

Description:

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.

Treatment:

Behavioral: CAMS - Phase 1

Behavioral: CAMS - Phase 2

CAMS to DBT

Experimental group

Description:

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.

Treatment:

Behavioral: CAMS - Phase 1

Behavioral: DBT - Phase 2

TAU to Maintenance

Experimental group

Description:

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.

Treatment:

Behavioral: TAU - Phase 1

TAU to CAMS

Experimental group

Description:

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.

Treatment:

Behavioral: CAMS - Phase 2

Behavioral: TAU - Phase 1

TAU to DBT

Experimental group

Description:

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.

Treatment:

Behavioral: DBT - Phase 2

Behavioral: TAU - Phase 1

DBT Only

Experimental group

Description:

Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.

Treatment:

Behavioral: DBT - Phase 1 and 2

Study Counselors

No Intervention group

Description:

Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups.