Video and Text Messaging Intervention for PTSD and Opioid Use Disorder

Overseen By Kate Walsh, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Under 18, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to prevent PTSD (post-traumatic stress disorder) and opioid misuse in individuals who have experienced sexual assault. Researchers are testing a video intervention called Skills Training in Active Recovery (STAR) and a month-long text messaging program called Text Skills Training in Active Recovery (TextSTAR) to support recovery and reduce the risk of these conditions. Participants will join different groups to determine which combination of video and text support is most effective. This study suits those who have undergone a sexual assault exam within the last week and are not dealing with severe injuries or legal issues. As an unphased trial, it offers a unique opportunity to contribute to innovative approaches in mental health support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this video and text messaging intervention is safe for individuals with PTSD and opioid use disorder?

Research has shown that the STAR Video and TextSTAR programs are safe and well-liked. Studies on the STAR Video indicate it is a helpful tool for sexual assault survivors, aiding their recovery with accessible video content. No negative effects have been reported from using the video.

The TextSTAR program sends supportive text messages and was developed with input from sexual assault survivors, ensuring the messages are relevant and sensitive to participants' experiences. Again, no negative effects have been reported from using this text messaging service.

Both tools aim to prevent PTSD and opioid misuse by teaching skills in a non-invasive way. As they are not medications, they avoid the usual risks of drug side effects. Instead, they provide supportive content through familiar video and text formats, which users generally find safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Skills Training in Active Recovery (STAR) program because it combines video and text messaging to support people with PTSD and opioid use disorder. Unlike traditional treatments, which might involve medication or face-to-face therapy, STAR offers a digital approach that can be accessed anytime, providing flexibility and convenience. The use of text messaging as a follow-up intervention is particularly innovative, allowing personalized support that adapts to an individual's progress in real-time. This method could make it easier for people to stick with their treatment and reduce symptoms more effectively.

What evidence suggests that this trial's treatments could be effective for PTSD and opioid misuse?

This trial will evaluate the effectiveness of the Skills Training in Active Recovery (STAR) video and the Text Skills Training in Active Recovery (TextSTAR) program for individuals with PTSD and opioid use disorder. Studies have shown that video and text messaging programs like STAR can aid recovery from PTSD and opioid misuse. Research indicates these methods enhance treatment accessibility and engagement. Evidence suggests psychological treatments have a small to medium positive effect on improving PTSD symptoms. The TextSTAR program, which uses messaging, has also been linked to reducing symptoms of substance use disorders. Together, these tools aim to prevent PTSD and opioid misuse from starting or worsening in survivors of sexual assault. Participants in this trial will be assigned to different arms to receive either the STAR video, the TextSTAR program, both, or neither, based on their initial assessment results. ^{1 2 3 6 7}

Who Is on the Research Team?

Kate Walsh, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for survivors of sexual assault who are at risk of developing or worsening PTSD and opioid misuse. Participants should be receiving care from a Sexual Assault Nurse Examiner (SANE).

Inclusion Criteria

Can read and respond to questions in English

I am not in the hospital for severe injuries, thoughts of suicide, or severe mental health issues.

Not currently or about to be incarcerated

Exclusion Criteria

I cannot read or respond to questionnaires in English.

Those seeking care that does not include a SANE exam

Those who cannot consent to receive SANE care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of video and text interventions with a sexual assault advisory board

Not specified

Treatment

Participants receive the STAR intervention video and may receive the textSTAR intervention based on PTSD or opioid misuse thresholds

1 month

1 visit (in-person) for video intervention, ongoing text messages

Follow-up

Participants are monitored for changes in PTSD, opioid misuse, and other secondary outcomes

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Skills Training in Active Recovery (STAR) Video
• Text Skills Training in Active Recovery (TextSTAR) program

Trial Overview The study tests two interventions: a brief video program called STAR delivered during SANE care, and TextSTAR, a text messaging program provided after the assault to help prevent PTSD and opioid misuse.

How Is the Trial Designed?

Group I: Video, Below Threshold Experimental Treatment 1 Intervention

Participants in this condition will receive the STAR intervention video and will be below threshold on PTSD and opioid misuse at 1 week and will not be randomized to receive further intervention.

Group II: Video, Above Threshold, Text Experimental Treatment 2 Interventions

Participants in this condition will receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to receive the textSTAR intervention.

Group III: Video, Above Threshold, No Text Experimental Treatment 1 Intervention

Participants in this condition will receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to not receive textSTAR.

Group IV: No Video, Above Threshold, Text Experimental Treatment 1 Intervention

Participants in this condition will not receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to receive the textSTAR intervention.

Group V: No Video, Above Threshold, No Text Active Control 1 Intervention

Participants in this condition will not receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will not be randomized to receive the textSTAR intervention.

Group VI: No Video, Below Threshold Active Control 1 Intervention

Participants in this condition will not receive the STAR intervention video and will be below threshold on PTSD and opioid misuse at 1 week and will not be randomized to receive further intervention.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A systematic review of 26 studies on treatment dropout from evidence-based psychotherapies (EBPs) for PTSD among OEF/OIF/OND veterans identified key factors contributing to dropout, including younger age, concurrent substance use, and practical concerns like balancing life roles.

Understanding these dropout factors is crucial for developing innovative strategies to improve treatment engagement and retention for veterans, ultimately enhancing their outcomes in PTSD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors contributing to PTSD treatment dropout in veterans returning from the wars in Iraq and Afghanistan: A systematic review. Sciarrino, NA., Bartlett, BA., Smith, LJ., et al.[2022]

A study involving 20 hospitalized individuals with opioid use disorder (OUD) found that 60% were interested in receiving text messages to help them quit smoking, indicating a strong potential for mobile health interventions in this population.

Participants rated messages about the health benefits of quitting smoking as the most motivating, suggesting that a text message program could effectively support smoking cessation efforts among individuals with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text-messaging to promote smoking cessation among individuals with opioid use disorder: quantitative and qualitative evaluation. Shankar, D., Borrelli, B., Cobb, V., et al.[2022]

The study involved 34 patients and compared the effectiveness of a combined treatment (Treatment As Usual plus Structured Writing Therapy) for co-morbid PTSD and severe Substance Use Disorder.

While both treatment groups showed a reduction in Substance Use Disorder symptoms, only the combined treatment group (TAU + SWT) demonstrated significant improvements in PTSD severity and remission of PTSD diagnoses, suggesting that adding trauma-focused therapy may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial. van Dam, D., Ehring, T., Vedel, E., et al.[2021]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

In a study of 89 adults seeking buprenorphine treatment for opioid use disorder (OUD) in rural Vermont, 31% reported a history of posttraumatic stress disorder (PTSD), highlighting the prevalence of PTSD among this population.

Individuals with PTSD were less likely to have received prior OUD treatment despite having better access to healthcare resources, and they experienced more severe psychiatric and medical issues, indicating a need for targeted interventions to support this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder in individuals seeking treatment for opioid use disorder in Vermont. Peck, KR., Moxley-Kelly, N., Badger, GJ., et al.[2022]

Mobile phone systems for treating alcohol-use disorders (AUDs) are categorized into four groups, with comprehensive recovery management systems showing the strongest theoretical support and longest-lasting effects.

While text-messaging applications may offer some benefits, they are likely not sufficient as standalone interventions for AUDs, highlighting the need for more robust and evidence-based solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Delivery of Treatment for Alcohol Use Disorders: A Review of the Literature. Quanbeck, A., Chih, MY., Isham, A., et al.[2022]

In a study of 5,901 U.S. veterans with PTSD and opioid use disorder (OUD), high adherence to medication-assisted treatment (MAT) was associated with a decreased risk of all-cause mortality, although the results were not statistically significant.

Patients who had more than 60 days of exposure to general substance abuse care showed a significant reduction in mortality from external causes and overdose or suicide, highlighting the importance of comprehensive care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between Medication Assisted Therapy Services Delivery and Mortality in a National Cohort of Veterans with Posttraumatic Stress Disorder and Opioid Use Disorder. Riblet, NB., Gottlieb, DJ., Shiner, B., et al.[2021]

In a study of 40 female survivors of intimate partner violence with PTSD and alcohol use disorder, older women and those with fewer dependents were more likely to engage in treatment, highlighting demographic factors that influence treatment retention.

Greater PTSD symptoms related to avoidance/numbing and longer histories of heavy drinking were also linked to higher treatment engagement, suggesting that specific symptom profiles may affect a person's likelihood to participate in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. Myers, US., Browne, KC., Norman, SB.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12360789/

Refining a Video and Text Message Intervention (STAR, ... This study describes a formative collaborative process of working with a CAB of SA survivors to refine content for a new video called Skills ...

2. researchgate.net researchgate.net/publication/392921382_Collaborating_with_a_Community_Advisory_Board_to_Refine_Skills_Training_in_Active_Recovery_STAR_a_Video_and_Text_Message_Intervention_to_Prevent_the_Onset_andor_Escalation_of_Posttraumatic_Stress_and_

a Video and Text Message Intervention to Prevent the ... Collaborating with a Community Advisory Board to Refine Skills Training in Active Recovery (STAR): a Video and Text Message Intervention to ...

3. withpower.com withpower.com/trial/phase-post-traumatic-stress-disorder-ptsd-8-2024-7232d

Video and Text Messaging Intervention for PTSD ... The STAR Video and TextSTAR program is unique because it uses video and text messaging to deliver skills training for recovery, making it more accessible and ...

4. samhsa.gov samhsa.gov/libraries/evidence-based-practices-resource-center

Evidence-Based Practices Resource Center This guide reviews ways that telehealth modalities can be used to provide treatment for serious mental illness and substance use disorders among adults, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772724622000063

Treatment of post-traumatic stress disorder and substance ... Two studies reported emotion regulation. Five studies found a small to medium positive effect size of psychological interventions on PTSD outcomes. Two studies ...

6. researchgate.net researchgate.net/publication/371046874_Study_protocol_for_a_hybrid_1_effectiveness-implementation_trial_of_Brief_Skills_Training_in_Affective_and_Interpersonal_Regulation_Brief_STAIR_and_web-administered_STAIR_webSTAIR_for_posttraumatic_st

Study protocol for a hybrid 1 effectiveness-implementation ... Impact of Race on Early Treatment Termination and Outcomes in Posttraumatic Stress Disorder Treatment. Article. Full-text available. Aug 2010.

7. samhsa.gov samhsa.gov/technical-assistance/brss-tacs/video-trainings

Video Trainings for Recovery Support Access video trainings that promote recovery-oriented services and supports by highlighting new knowledge areas, hot topics, and cutting edge programs.