Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05959434
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-05-19
Brief Title:
Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
Sponsor:
Texas AM University
Organization:
Texas AM University
Study Overview
Official Title:
Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPTRP
Brief 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
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 CPTRP with RP-alone to see if CPTRP is more efficacious in reducing alcohol use and PTSD symptom severity
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 CPTRP with RP-alone to see if CPTRP 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 AUDPTSD 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 800 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 840 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 AUDPTSD 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 AUDPTSD 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 AUDPTSD 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 AUDPTSD comorbidity and innovate clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA030157 | NIH | None | httpsreporternihgovquickSearchR01AA030157 |