Posttraumatic Stress DisorderPhase 2CPT+RPNCT05959434
Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
A Phase 2 study testing Cognitive Processing Therapy + Relapse Prevention and Relapse Prevention in people with Posttraumatic Stress Disorder and Alcohol Use Disorder, run by Texas A&M University at 2 sites in United States.
Trial summary
The goal of this clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Alcohol Use Disorder
- What is being tested?
- Cognitive Processing Therapy + Relapse Prevention and Relapse Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2024to 31 Jul 2028
- Phase
- Phase 2
- 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
- Any gender identity, any race or ethnicity, 18 years of age or older.
- Able to provide written informed consent.
- Ability to understand English.
- Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( >= 4 criteria).
- At least 3 to 4 heavy drinking days per week (4 or more drinks for a woman, 5 or more drinks for a man) in the last 30 days, or >14 drinks per week for females or > 21 drinks per week for males for at least 2 weeks in the last 30 days.
- Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5.
- Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders. The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and anxiety disorders among patients with AUD and PTSD. Concurrent substance use disorders are acceptable provided alcohol is the participant's primary substance of choice.
- Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.
Who cannot join
- Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior. The intervention may be insufficient, and those participants will be referred clinically for a higher level of care.
- Participants on psychotropic medications which have been initiated during the past 4 weeks.
- Acute alcohol withdrawal as indicated by CIWA-Ar scores >8. Those participants will be referred clinically for medically supervised detoxification. They may be re-evaluated for eligibility after detoxification.
- Pregnancy or breastfeeding for women.
- Currently enrolled in evidence-based behavioral treatment for AUD or PTSD. Attendance at therapeutic activities (e.g., Alcoholics Anonymous) other than study sessions will be closely monitored using the Treatment Services Review.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sudie E Back, Ph.D. contact
United States2 sites, 2 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Sudie E Back, PHD, backs@musc.edu
Stacey Sellers, MS, sellersst@musc.edu
- Recruiting
Texas A&M University
College Station, Texas, 77843
Anka A Vujanovic, PHD, 979-862-6538, avujanovic@tamu.edu
Kat Roberts, 854-253-9987, kbroberts@tamu.edu
About this study
Official title: Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial
The goal of this clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD).
Specific Aim 1: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing alcohol frequency (percent days drinking) and quantity (drinks per drinking day) as measured by the Timeline Follow-Back (TLFB).
Read more
Specific Aim 2: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5).
Specific Aim 3: Use ecological momentary assessment (EMA) to evaluate intervention effects on daily alcohol-related cognitions and behaviors through real-time associations with PTSD symptomatology and distress tolerance.
Researchers will compare integrative CPT+RP with RP-alone to see if CPT+RP is more efficacious in reducing alcohol use and PTSD symptom severity.
Read the detailed description
A substantial proportion of individuals with alcohol use disorder (AUD) also meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of AUD/PTSD is characterized by more severe symptomatology, greater functional impairment, increased suicide risk, and poorer treatment outcomes as compared to either disorder alone. Trauma-focused, cognitive-behavioral interventions delivered alongside interventions for substance use disorders are most effective in reducing PTSD severity and substance use. Cognitive Processing Therapy (CPT) for PTSD and Relapse Prevention (RP) for AUD are two of the most widely used and efficacious behavioral treatments for these conditions. The investigators successfully developed and pilot tested a therapy manual that combines CPT with RP. The preliminary data demonstrate safety, feasibility, high rates of retention (80.0%) and patient satisfaction. Moreover, our data from a recent national survey of frontline mental health providers indicate that CPT is the most commonly used trauma-focused treatment for PTSD and providers are highly interested in an integrative CPT-RP intervention, conferring strong potential for uptake in real-world practice settings. In fact, due to the lack of an available, empirically developed, manualized CPT-RP treatment, 84.0% of frontline providers report attempting on their own to create such a treatment to use with their patients. This may result in highly variable and suboptimal implementation and outcomes. In response to provider input and positive preliminary data, the proposed study directly addresses this critical need by evaluating a new integrative CPT-RP treatment for individuals with co-occurring AUD and PTSD. At present, only one trauma-focused, integrative intervention is available for AUD/PTSD and it uses Prolonged Exposure (PE) to reduce PTSD symptoms. In comparison to PE, CPT is more widely used, often preferred by clinicians, equally as effective in reducing PTSD symptoms, and associated with lower dropout rates. Thus, the new CPT-RP intervention could have wider reach and greater acceptability than exposure-based treatments. Treatment choice is related to improved treatment outcomes, and therefore, there is an immediate need to add to the portfolio of evidence-based, trauma-focused, integrative treatments for AUD/PTSD. The primary objective of this Stage II study is to examine the efficacy of CPT-RP, as compared to RP alone, in reducing (1) alcohol use frequency and quantity and (2) PTSD symptom severity among individuals with current AUD/PTSD. To accomplish this, a randomized study design, manualized intervention, and standardized repeated dependent measures of clinical outcomes at multiple time points will be employed. Putative mechanisms of behavior change will be evaluated via daily monitoring. The proposed study aligns closely with the mission of NIAAA in that it aims to produce maximally efficacious behavioral interventions for AUD and comorbid psychiatric disorders such as PTSD. The findings from this study will provide new information to advance the science of AUD/PTSD comorbidity and innovate clinical practice.
- Being tested
- Cognitive Processing Therapy + Relapse Prevention, Relapse Prevention
- Keywords
- trauma or PTSD, alcohol use, Cognitive Processing Therapy, Relapse Prevention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism, Wounds and Injuries, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy + Relapse PreventionBehavioural
Cognitive-Behavioral Therapy that integrates Cognitive Processing Therapy for PTSD with Relapse Prevention for alcohol use disorder
Relapse PreventionBehavioural
Cognitive-Behavioral Therapy that targets alcohol use, specifically
| Study group | Role | What they receive |
|---|---|---|
| Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP) | Experimental | Participants will receive 12, 90-minute individual sessions of CPT+RP delivered twice-weekly. We will offer some flexibility (e.g., due to illness or scheduling conflicts) and allow up to 9 weeks to complete all 12 sessions if needed. During CPT+RP, patients receive psychoeducation pertaining to the interconnectedness of AUD and PTSD and learn techniques to identify and manage triggers for alcohol use, cope with cravings, address problem thoughts about drinking, and enhance social support. These skills address core functional outcomes relevant to addiction, including executive functioning, incentive salience, and negative emotionality. The PTSD treatment component of CPT+RP reduces PTSD symptoms via identifying and targeting maladaptive trauma-related cognitions, beliefs, and Stuck Points via cognitive restructuring exercises, such as Socratic questioning. RP skills are integrated within each session. Receives: Behavioral: Cognitive Processing Therapy + Relapse Prevention |
| Relapse Prevention (RP) | Active comparator | Participants will receive 12, 90-minute individual sessions of RP delivered twice-weekly as consistent with the experimental condition. The RP manual is adapted from the NIAAA Project MATCH Cognitive-Behavioral Coping Skills Therapy Manual and has been used in prior NIH-funded trials of integrated, trauma-focused treatment. Session topics include, for example, Triggers for Alcohol Use, Coping with Cravings and Urges to Drink (e.g., avoid alcohol cues, distracting activities, talk to friends/family, urge surfing), Managing Thoughts about Alcohol and Drinking by challenging and changing thoughts, Planning for Emergencies and Coping with a Lapse, Drink Refusal Skills, Increasing Pleasant Activities and Enhancing Social Support. Receives: Behavioral: Relapse Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use
Composite of alcohol use frequency (percent days drinking) and quantity (drinks per drinking day), as measured by the Timeline Follow-Back
Measured: through study treatment completion, an average of 12 weeks
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Measured: through study treatment completion, an average of 12 weeks
Secondary outcomes (2)
Change in Alcohol Use
Composite of alcohol use frequency (percent days drinking) and quantity (drinks per drinking day), as measured by the Timeline Follow-Back
Measured: At 3 months, 6 months, and 12 months following study treatment completion
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Measured: At 3 months, 6 months, and 12 months following study treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Apr 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Anka Vujanovic, Texas A&M University
- Investigators
- Anka A Vujanovic, Ph.D., Principal investigator, Texas A&M UniversitySudie E Back, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959434
- Sponsor's protocol ID
- IRB2023-0985 / 162260
- Other IDs
- R01AA030157
- Acronym
- CPT+RP
- Status last verified
- Apr 2026
- First submitted
- 19 May 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05959434
- Acronym / sponsor ID
- CPT+RP / IRB2023-0985 / 162260
- Keywords
- trauma or PTSD, alcohol use, Cognitive Processing Therapy, Relapse Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 25 Jul 2023 (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 clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD).
Specific Aim 1: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing alcohol frequency (percent days drinking) and quantity (drinks per drinking day) as measured by the Timeline Follow-Back (TLFB).
Specific Aim 2: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5).
Specific Aim 3: Use ecological momentary assessment (EMA) to evaluate intervention effects on daily alcohol-related cognitions and behaviors through real-time associations with PTSD symptomatology and distress tolerance.
Researchers will compare integrative CPT+RP with RP-alone to see if CPT+RP is more efficacious in reducing alcohol use and PTSD symptom severity.
Detailed description
A substantial proportion of individuals with alcohol use disorder (AUD) also meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of AUD/PTSD is characterized by more severe symptomatology, greater functional impairment, increased suicide risk, and poorer treatment outcomes as compared to either disorder alone. Trauma-focused, cognitive-behavioral interventions delivered alongside interventions for substance use disorders are most effective in reducing PTSD severity and substance use. Cognitive Processing Therapy (CPT) for PTSD and Relapse Prevention (RP) for AUD are two of the most widely used and efficacious behavioral treatments for these conditions. The investigators successfully developed and pilot tested a therapy manual that combines CPT with RP. The preliminary data demonstrate safety, feasibility, high rates of retention (80.0%) and patient satisfaction. Moreover, our data from a recent national survey of frontline mental health providers indicate that CPT is the most commonly used trauma-focused treatment for PTSD and providers are highly interested in an integrative CPT-RP intervention, conferring strong potential for uptake in real-world practice settings. In fact, due to the lack of an available, empirically developed, manualized CPT-RP treatment, 84.0% of frontline providers report attempting on their own to create such a treatment to use with their patients. This may result in highly variable and suboptimal implementation and outcomes. In response to provider input and positive preliminary data, the proposed study directly addresses this critical need by evaluating a new integrative CPT-RP treatment for individuals with co-occurring AUD and PTSD. At present, only one trauma-focused, integrative intervention is available for AUD/PTSD and it uses Prolonged Exposure (PE) to reduce PTSD symptoms. In comparison to PE, CPT is more widely used, often preferred by clinicians, equally as effective in reducing PTSD symptoms, and associated with lower dropout rates. Thus, the new CPT-RP intervention could have wider reach and greater acceptability than exposure-based treatments. Treatment choice is related to improved treatment outcomes, and therefore, there is an immediate need to add to the portfolio of evidence-based, trauma-focused, integrative treatments for AUD/PTSD. The primary objective of this Stage II study is to examine the efficacy of CPT-RP, as compared to RP alone, in reducing (1) alcohol use frequency and quantity and (2) PTSD symptom severity among individuals with current AUD/PTSD. To accomplish this, a randomized study design, manualized intervention, and standardized repeated dependent measures of clinical outcomes at multiple time points will be employed. Putative mechanisms of behavior change will be evaluated via daily monitoring. The proposed study aligns closely with the mission of NIAAA in that it aims to produce maximally efficacious behavioral interventions for AUD and comorbid psychiatric disorders such as PTSD. The findings from this study will provide new information to advance the science of AUD/PTSD comorbidity and innovate clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP) | Experimental | Behavioral: Cognitive Processing Therapy + Relapse PreventionParticipants will receive 12, 90-minute individual sessions of CPT+RP delivered twice-weekly. We will offer some flexibility (e.g., due to illness or scheduling conflicts) and allow up to 9 weeks to complete all 12 sessions if needed. During CPT+RP, patients receive psychoeducation pertaining to the interconnectedness of AUD and PTSD and learn techniques to identify and manage triggers for alcohol use, cope with cravings, address problem thoughts about drinking, and enhance social support. These skills address core functional outcomes relevant to addiction, including executive functioning, incentive salience, and negative emotionality. The PTSD treatment component of CPT+RP reduces PTSD symptoms via identifying and targeting maladaptive trauma-related cognitions, beliefs, and Stuck Points via cognitive restructuring exercises, such as Socratic questioning. RP skills are integrated within each session. |
| Relapse Prevention (RP) | Active comparator | Behavioral: Relapse PreventionParticipants will receive 12, 90-minute individual sessions of RP delivered twice-weekly as consistent with the experimental condition. The RP manual is adapted from the NIAAA Project MATCH Cognitive-Behavioral Coping Skills Therapy Manual and has been used in prior NIH-funded trials of integrated, trauma-focused treatment. Session topics include, for example, Triggers for Alcohol Use, Coping with Cravings and Urges to Drink (e.g., avoid alcohol cues, distracting activities, talk to friends/family, urge surfing), Managing Thoughts about Alcohol and Drinking by challenging and changing thoughts, Planning for Emergencies and Coping with a Lapse, Drink Refusal Skills, Increasing Pleasant Activities and Enhancing Social Support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any gender identity, any race or ethnicity, 18 years of age or older.
- Able to provide written informed consent.
- Ability to understand English.
- Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( >= 4 criteria).
- At least 3 to 4 heavy drinking days per week (4 or more drinks for a woman, 5 or more drinks for a man) in the last 30 days, or >14 drinks per week for females or > 21 drinks per week for males for at least 2 weeks in the last 30 days.
Key exclusion criteria (5 listed)
- Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior. The intervention may be insufficient, and those participants will be referred clinically for a higher level of care.
- Participants on psychotropic medications which have been initiated during the past 4 weeks.
- Acute alcohol withdrawal as indicated by CIWA-Ar scores >8. Those participants will be referred clinically for medically supervised detoxification. They may be re-evaluated for eligibility after detoxification.
- Pregnancy or breastfeeding for women.
- Currently enrolled in evidence-based behavioral treatment for AUD or PTSD. Attendance at therapeutic activities (e.g., Alcoholics Anonymous) other than study sessions will be closely monitored using the Treatment Services Review.
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 |
|---|---|---|
| Cognitive Processing Therapy + Relapse PreventionCognitive-Behavioral Therapy that integrates Cognitive Processing Therapy for PTSD with Relapse Prevention for alcohol use disorder | Behavioural | Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP) |
| Relapse PreventionCognitive-Behavioral Therapy that targets alcohol use, specifically | Behavioural | Relapse Prevention (RP) |
Primary outcome
Change in Alcohol Use
Time frame: through study treatment completion, an average of 12 weeks
Composite of alcohol use frequency (percent days drinking) and quantity (drinks per drinking day), as measured by the Timeline Follow-Back
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
Time frame: through study treatment completion, an average of 12 weeks
PTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
2 secondary outcomes
Change in Alcohol Use
Time frame: At 3 months, 6 months, and 12 months following study treatment completion
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
Time frame: At 3 months, 6 months, and 12 months following study treatment completion
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 24 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
Sudie E Back, Ph.D. contact
Anka A Vujanovic, Ph.D. principal investigator
Texas A&M University
Sudie E Back, Ph.D. principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Processing Therapy + Relapse Prevention and Relapse Prevention in people with Posttraumatic Stress Disorder and Alcohol Use Disorder, run by Texas A&M University at 2 sites 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 8 inclusion and 5 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 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anka A Vujanovic, Ph.D. (979-862-6538, avujanovic@tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Use (time frame: through study treatment completion, an average of 12 weeks). 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 24 Apr 2026.