Health TrialsbyHealthPanel

Massed Prolonged Exposure for PTSD in Substance Use Treatment

ConditionsStress Disorders, Post-TraumaticSubstance Use Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVeterans Medical Research Foundation

About this trial

The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:

* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms? * Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veterans

age 18+

who have served since September 2001

who are enrolled in a SUD IOP at a participating VA

Disqualifiers

severe cognitive impairment

current suicidal or homicidal intent requiring immediate treatment

current unstable psychotic or manic symptoms not attributable to SUD

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prolonged Exposure Therapy

    Behavioral

    Exposure therapy for PTSD

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Massed PEExperimental treatment 1 intervention
Group B: Weekly PEActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity

Time frame
At 4-, 16-, 28-, and 40-weeks post-first therapy session
2

Time Line Follow back (TLFB)

Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use

Time frame
At 4-, 16-, 28-, and 40-weeks post-first therapy session
3

Psychotherapy Completion Rates

Percent of participants completing all sessions of psychotherapy, range is 0-100%, higher number means greater percent completed therapy

Time frame
16 weeks

Secondary outcomes

1

Patient Health Questionnaire-9 (PHQ-9)

Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity

Time frame
At 4-, 16-, 28-, and 40-weeks post-first therapy session
2

Brief Psychosocial Functioning Inventory (B-IPF)

Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment

Time frame
At 4-, 16-, 28-, and 40-weeks post-first therapy session
3

Client Satisfaction Questionnaire-8 (CSQ-8)

Measures satisfaction with treatment, scores range from 8 to 32. higher scores indicate greater satisfaction with treatment

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Veterans Medical Research Foundation

Lead sponsor

University of Minnesota

Collaborator

Center for Veterans Research and Education

Collaborator

Source ClinicalTrials.gov
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