PTSDNCT01663337
Sequence of Symptom Change During AUD or PTSD Treatment for Comorbid PTSD/AUD
A study testing Cognitive Processing Therapy (CPT) and Relapse Prevention (RP) in people with PTSD and Alcohol Abuse, run by University of Washington at 2 sites in United States.
Trial summary
The broad, long-term objective of the current research is to improve treatment outcomes for individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and dependence (AUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Alcohol Abuse, Alcohol Dependence
- What is being tested?
- Cognitive Processing Therapy (CPT) and Relapse Prevention (RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men and women age ≥ 18 years with a current DSM-V diagnosis of alcohol abuse/dependence
- Recent alcohol consumption for at least 2 weeks in the past 30 day period OR at least 2 days of heavy drinking in the past 30 day period
- Desire to abstain from alcohol
- Current DSM-V (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of PTSD
- Capacity to provide informed consent
- English fluency
Who cannot join
- Men and women with an unstable psychiatric medication regimen
- Current trauma-focused mental health treatment (MH) or behaviorally focused alcohol dependence (AD) AD/MH treatment in the past 30 days
- Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month
- Presence of a psychotic disorder or uncontrolled Bipolar Disorder
- Signs or symptoms of alcohol withdrawal at the time of initial consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harborview Center for Sexual Assault and Traumatic Stress
Seattle, Washington, 98104
VA Puget Sound Health Care (Seattle Campus)
Seattle, Washington, 98108
About this study
Official title: Sequence of Symptom Change During AUD (Alcohol Use or Dependence) or PTSD (Posttraumatic Stress Disorder) Treatment for Comorbid PTSD/AUD
The broad, long-term objective of the current research is to improve treatment outcomes for individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and dependence (AUD).
The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP) treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.
The study will randomize 235 PTSD/AUD participants recruited from the VA and from the community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months post-treatment and will monitor symptoms daily throughout treatment.
Read the detailed description
Prior research has established that PTSD and AUD are frequently comorbid.
Although combined treatments have been developed, they are complex and lengthy with mixed results as to their efficacy. Excellent treatments exist for PTSD or AUD alone, however, it has not been adequately addressed to what extent these treatments are effective in treating comorbid symptom presentations. To address this research gap, the investigators will evaluate two widely accepted treatments for each respective disorder; Cognitive Processing Therapy (CPT) an effective PTSD treatment and Relapse Prevention (RP), a widely used effective AUD treatment.
The investigators will build on our prior work using a daily telephone Interactive Voice Response (IVR) system to test models of self-medication and the sequence of symptom change for both primary and secondary symptom targets associated with each therapy.
Creating a more comprehensive model of symptom change in PTSD and alcohol use with widely used selective treatments is critical in testing theories of PTSD/AUD, evaluating these treatments for use with PTSD/AUD, and implementing these therapies with PTSD/AUD patients in standard clinical practice
- Conditions
- PTSD, Alcohol Abuse, Alcohol Dependence
- Being tested
- Cognitive Processing Therapy (CPT), Relapse Prevention (RP)
- Keywords
- Posttraumatic Stress Disorder, PTSD, Alcohol Abuse, Alcohol Dependance, Alcoholism, Comorbid, Relapse Prevention (RP), Cognitive Processing Therapy (CPT)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy (CPT)Behavioural
CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.
Relapse Prevention (RP)Behavioural
RP utilizes high-risk situation assessment/avoidance, drink refusal skills, assertiveness training,cognitive restructuring as well as other approaches to address issues of alcohol use/dependance.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Active comparator | Not described Receives: Behavioral: Cognitive Processing Therapy (CPT) |
| Relapse Prevention Therapy (RP) | Active comparator | Not described Receives: Behavioral: Relapse Prevention (RP) |
| Assessment Only (AO) | No intervention | AO functions as a benchmark comparison condition. Consists of baseline assessment, daily interactive voice response (IVR) monitoring, and immediate post-test assessment. Not an active treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS)
Measured: 12 Months
Reduction in alcohol consumption from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Form-90 (Alcohol Consumption)
Measured: 12 months
Secondary outcomes (3)
Anxiety (GAD-7 & OASIS)
Measured: Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment
Penn Alcohol Craving Scale (PACS)
Measured: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment
Patient Health Questionnaire Depression Scale (PHQ-9)
Measured: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startMar 2013
- Primary completionSep 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Debra Kaysen, University of Washington
- Investigators
- Debra Kaysen, Principal investigator, Univeristy of WashingtonTracy Simpson, Principal investigator, VA Puget Sound Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663337
- Sponsor's protocol ID
- 39884
- Other IDs
- 1R01AA020252
- Status last verified
- Jul 2018
- First submitted
- 2 Aug 2012
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Simpson TL, Kaysen DL, Fleming CB, Rhew IC, Jaffe AE, Desai S, Hien DA, Berliner L, Donovan D, Resick PA. Cognitive Processing Therapy or Relapse Prevention for comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A randomized clinical trial. PLoS One. 2022 Nov 29;17(11):e0276111. doi: 10.1371/journal.pone.0276111. eCollection 2022.
PubMed 36445895
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequence of Symptom Change During AUD (Alcohol Use or Dependence) or PTSD (Posttraumatic Stress Disorder) Treatment for Comorbid PTSD/AUD
- ClinicalTrials.gov ID
- NCT01663337
- Acronym / sponsor ID
- 39884
- Conditions
- PTSD, Alcohol Abuse, Alcohol Dependence
- Keywords
- Posttraumatic Stress Disorder, PTSD, Alcohol Abuse, Alcohol Dependance, Alcoholism, Comorbid, Relapse Prevention (RP), Cognitive Processing Therapy (CPT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Mar 2013
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 13 Aug 2012 (estimated)
- 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 broad, long-term objective of the current research is to improve treatment outcomes for individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and dependence (AUD).
The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP) treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.
The study will randomize 235 PTSD/AUD participants recruited from the VA and from the community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months post-treatment and will monitor symptoms daily throughout treatment.
Detailed description
Prior research has established that PTSD and AUD are frequently comorbid.
Although combined treatments have been developed, they are complex and lengthy with mixed results as to their efficacy. Excellent treatments exist for PTSD or AUD alone, however, it has not been adequately addressed to what extent these treatments are effective in treating comorbid symptom presentations. To address this research gap, the investigators will evaluate two widely accepted treatments for each respective disorder; Cognitive Processing Therapy (CPT) an effective PTSD treatment and Relapse Prevention (RP), a widely used effective AUD treatment.
The investigators will build on our prior work using a daily telephone Interactive Voice Response (IVR) system to test models of self-medication and the sequence of symptom change for both primary and secondary symptom targets associated with each therapy.
Creating a more comprehensive model of symptom change in PTSD and alcohol use with widely used selective treatments is critical in testing theories of PTSD/AUD, evaluating these treatments for use with PTSD/AUD, and implementing these therapies with PTSD/AUD patients in standard clinical practice
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Active comparator | Behavioral: Cognitive Processing Therapy (CPT) |
| Relapse Prevention Therapy (RP) | Active comparator | Behavioral: Relapse Prevention (RP) |
| Assessment Only (AO) | No intervention | –AO functions as a benchmark comparison condition. Consists of baseline assessment, daily interactive voice response (IVR) monitoring, and immediate post-test assessment. Not an active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women age ≥ 18 years with a current DSM-V diagnosis of alcohol abuse/dependence
- Recent alcohol consumption for at least 2 weeks in the past 30 day period OR at least 2 days of heavy drinking in the past 30 day period
- Desire to abstain from alcohol
- Current DSM-V (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of PTSD
- Capacity to provide informed consent
Key exclusion criteria (5 listed)
- Men and women with an unstable psychiatric medication regimen
- Current trauma-focused mental health treatment (MH) or behaviorally focused alcohol dependence (AD) AD/MH treatment in the past 30 days
- Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month
- Presence of a psychotic disorder or uncontrolled Bipolar Disorder
- Signs or symptoms of alcohol withdrawal at the time of initial consent
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 (CPT)CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs. | Behavioural | Cognitive Processing Therapy (CPT) |
| Relapse Prevention (RP)RP utilizes high-risk situation assessment/avoidance, drink refusal skills, assertiveness training,cognitive restructuring as well as other approaches to address issues of alcohol use/dependance. | Behavioural | Relapse Prevention Therapy (RP) |
Primary outcome
Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS)
Time frame: 12 Months
Reduction in alcohol consumption from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Form-90 (Alcohol Consumption)
Time frame: 12 months
3 secondary outcomes
Anxiety (GAD-7 & OASIS)
Time frame: Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment
Penn Alcohol Craving Scale (PACS)
Time frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment
Patient Health Questionnaire Depression Scale (PHQ-9)
Time frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 36445895Simpson TL, Kaysen DL, Fleming CB, Rhew IC, Jaffe AE, Desai S, Hien DA, Berliner L, Donovan D, Resick PA. Cognitive Processing Therapy or Relapse Prevention for comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A randomized clinical trial. PLoS One. 2022 Nov 29;17(11):e0276111. doi: 10.1371/journal.pone.0276111. eCollection 2022.
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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. This study is not recruiting at the moment.
Debra Kaysen principal investigator
Univeristy of Washington
Tracy Simpson principal investigator
VA Puget Sound Health Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy (CPT) and Relapse Prevention (RP) in people with PTSD and Alcohol Abuse, run by University of Washington 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 6 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS) (time frame: 12 Months). 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?
On the ClinicalTrials.gov record for NCT01663337, which also lists 1 linked publication.
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 18 Jul 2018.