Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD)

The University of Texas System (UT)

Status: Enrolling

Conditions: Posttraumatic Stress Disorder; PTSD

Treatments: Behavioral: Modular Cognitive Processing Therapy; Behavioral: Step Down Treatment; Behavioral: Digital Interventions; Behavioral: Prolonged Exposure (PE); Behavioral: Modular Prolonged Exposure Therapy; Behavioral: Cognitive Processing Therapy (CPT)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07176273

STUDY00001551

HT9425-24-1-1026 (Other Grant/Funding Number)

Details and patient eligibility

About

By doing this research project, the investigators hope to learn which strategies work best to help veterans who are not benefiting from their first PTSD treatment or not completing between-session homework assignments regularly that might improve treatment response. The investigators also want to learn how best to match the right type and amount of treatment to each individual veteran. By conducting this research project, they hope to:

• See if trying a different treatment strategy for veterans not responding to their first PTSD treatment would be more helpful
• See if sending text message prompts between sessions encourages more completion of between-session homework

Full description

This study is designed to assist the investigators in answering the clinical question of how to address non-response to first line PTSD treatments. Utilizing an innovative Hybrid Experimental Design (HED), the proposed study involves multiple, sequential randomizations to both therapist-delivered and digital interventions operating on short and long timescales to determine the optimal combination and sequencing of evidence-based interventions to maximize response. This will result in actionable data and, consistent with a personalized medicine approach, an implementable, adaptive treatment regimen that optimizes clinical resource allocation. By recruiting and providing treatment in routine care settings serving veterans with PTSD, the study design maximizes generalizability, relevance to the VA mission, and implementation potential.

Enrollment: 302 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Veterans eligible for PE and CPT at the participating PTSD treatment-providing clinic who are
2. At least 18 years or older
3. Score ≥ 31 on the PCL-5 secondary to a Criterion A traumatic event
4. Own a mobile device that can be used for the therapy companion mobile app (Prolonged Exposure (PE) coach or Cognitive Processing Therapy (CPT) coach).

Exclusion criteria

1. Acute suicide risk requiring clinical intervention
2. Need for detoxification
3. Unmanaged psychosis or bipolar disorder
4. Severe cognitive impairment that makes it unlikely that participants can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
5. Current or past 12-month engagement in PE or CPT.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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302 participants in 8 patient groups

Early CPT Non-Responders Switch (Group A)

Active Comparator group

Description:

Early NON-RESPONDERS to CPT will SWITCH to PE

Treatment:

Behavioral: Cognitive Processing Therapy (CPT)

Behavioral: Prolonged Exposure (PE)

Behavioral: Digital Interventions

Early CPT Non-Responders Modular (Group B)

Active Comparator group

Description:

Early NON-RESPONDERS to CPT will transition to MODULAR CPT

Treatment:

Behavioral: Cognitive Processing Therapy (CPT)

Behavioral: Digital Interventions

Behavioral: Modular Cognitive Processing Therapy

Early CPT Responders Continue (Group C)

Active Comparator group

Description:

Early RESPONDERS to CPT will CONTINUE in their CPT treatment

Treatment:

Behavioral: Cognitive Processing Therapy (CPT)

Behavioral: Digital Interventions

Early CPT Responders Step Down (Group D)

Active Comparator group

Description:

Early RESPONDERS to CPT will STEP DOWN to self-managed CPT

Treatment:

Behavioral: Cognitive Processing Therapy (CPT)

Behavioral: Digital Interventions

Behavioral: Step Down Treatment

Early PE Non-Responsers Switch (Group E)

Active Comparator group

Description:

Early NON-RESPONDERS to PE will SWITCH to CPT

Treatment:

Behavioral: Cognitive Processing Therapy (CPT)

Behavioral: Prolonged Exposure (PE)

Behavioral: Digital Interventions

Early PE Non-Responders Modular (Group F)

Active Comparator group

Description:

Early NON-RESPONDERS to PE will transition to MODULAR PE

Treatment:

Behavioral: Modular Prolonged Exposure Therapy

Behavioral: Prolonged Exposure (PE)

Behavioral: Digital Interventions

Early PE Responders Continue (Group G)

Active Comparator group

Description:

Early RESPONDERS will CONTINUE in their PE treatment

Treatment:

Behavioral: Prolonged Exposure (PE)

Behavioral: Digital Interventions

Early PE Responders Step Down (Group H)

Active Comparator group

Description:

Early RESPONDERS to PE will STEP DOWN to self-managed PE

Treatment:

Behavioral: Prolonged Exposure (PE)

Behavioral: Digital Interventions

Behavioral: Step Down Treatment