NCT01357577: CBT

Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs

Completed NA Results posted Last updated 29 January 2020

What this trial tests

NA trial testing Cognitive behavioral therapy for PTSD in PTSD in 129 participants. Completed in 31 October 2017.

Timeline

1 January 2013

Primary endpoint
31 October 2017

31 October 2017

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	129
Start date	1 January 2013
Primary completion	31 October 2017
Estimated completion	31 October 2017
Sites	3 locations across United States

Drugs / interventions tested

• Cognitive behavioral therapy for PTSD

Conditions studied

• PTSD — all drugs for PTSD →
• Substance Use Disorders — all drugs for Substance Use Disorders →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with PTSD or Substance Use Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. Primary · Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up

PTSD symptom severity will be measured by the Clinician Administered PTSD Scale (CAPS). The Clinician Administered PTSD SCALE (CAPS) is the gold standard in PTSD assessment. It is a structured interview that can be used to: Make current (past month) diagnosis of PTSD and Make lifetime diagnosis of PTSD. The minimum value is a 0 and the maximum is 135, the higher the score the worse the outcome, i.e. the more severe PTSD.

CAPS Total Baseline

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	77.2	± 18.4
Treatment as Usual	78.0	± 16.2

CAPS Total Post-Treatment

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	67.5	± 26.3
Treatment as Usual	71.0	± 26.4

CAPS Total 6 Months

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	72.2	± 21.6
Treatment as Usual	62.9	± 21.9

Addiction Severity Index (Alcohol Addiction) Secondary · Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months

The ASI is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.

Alcohol Baseline

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	.25	± .22
Treatment as Usual	.25	± .25

Alcohol Post-Treatment

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	.13	± .17
Treatment as Usual	.17	± .22

Alcohol 6-Months

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	.18	± .18
Treatment as Usual	.20	± .27

Addiction Severity Index (Drug Use) Secondary · Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months

The ASI is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.

Drug Use Baseline

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	.17	± .18
Treatment as Usual	.10	± .11

Drug Use Post-Treatment

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	.09	± .18
Treatment as Usual	.08	± .13

Drug Use 6-Months

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	.11	± .15
Treatment as Usual	.04	± .08

PTSD Checklist (PCL) Secondary · Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months

A secondary measure of PTSD will be the PCL. The PCL is a widely used self-report measure that assesses the 17 DSM-IV PTSD symptoms. Responses to these questions are on a scale of 1 to 5 ("not at all" to "extremely"). A total symptom severity score (range from 17-85) can be calculated, with a higher score indicating higher symptom severity.

PCL Baseline

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	62.7	± 9.2
Treatment as Usual	62.1	± 13.3

PCL Post-Treatment

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	54.3	± 17.7
Treatment as Usual	56.9	± 15.7

PCL 6-months

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	56.7	± 13.7
Treatment as Usual	54.2	± 16.9

Patient Health Questionnaire-9 (PHQ-9) Secondary · Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months

Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is adapted from the PRIME-MD. It can be used as a screen for depression or as a severity measure. The investigators used it as a measure of severity. The PHQ-9 score is on a range of 0 to 27, where a higher score indicates higher severity.

PHQ-9 Baseline

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	16.0	± 4.7
Treatment as Usual	14.8	± 6.8

PHQ-9 Post-Treatment

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	15.0	± 7.4
Treatment as Usual	12.8	± 7.2

PHQ-9 6-months

Group	Value	95% CI
Cognitive Behavioral Therapy + Treatment as Usual	15.8	± 17.1
Treatment as Usual	12.2	± 7.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU)

Serious: 11/64 (17%)

Deaths: 0/64

Treatment as Usual (TAU)

Serious: 13/65 (20%)

Deaths: 1/65

Serious adverse events (8 terms)

Reaction	System	Cognitive Behavioral Thera…	Treatment as Usual (TAU)
Mental Health Episode resulting in hospital encounter	Psychiatric disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Hospitalization for kidney failure	Renal and urinary disorders	—	—
Hospitalization due to hip replacement surgery	Musculoskeletal and connective tissue disorders	—	—
incarceration	Social circumstances	—	—
inpatient stay for untreated COPD	Respiratory, thoracic and mediastinal disorders	—	—
Testicular and groin surgery resulting in inpatient hospital stay	Renal and urinary disorders	—	—
hospitalization due to syncopal episode	Nervous system disorders	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Cognitive Behavioral Thera…	Treatment as Usual (TAU)
Mental Health and/or Substance Abuse ER visit	Psychiatric disorders	—	—
musculature pain and discomfort	Musculoskeletal and connective tissue disorders	—	—
chronic pain	General disorders	—	—
abdominal pain	Gastrointestinal disorders	—	—
headache	General disorders	—	—
Jail	Social circumstances	—	—
corneal abrasion	Eye disorders	—	—
ER visit due to dental pain and/or possible dental abscess	General disorders	—	—
chest pain	Cardiac disorders	—	—
low back pain	Musculoskeletal and connective tissue disorders	—	—
kidney stones	Renal and urinary disorders	—	—
hemophilia	Blood and lymphatic system disorders	—	—
testicular pain	General disorders	—	—
motor vehicle accident which results in paralysis	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Mental Health Episode resulting in hospital encounter, Myocardial infarction, Hospitalization for kidney failure, Hospitalization due to hip replacement surgery, incarceration, inpatient stay for untreated COPD, Testicular and groin surgery resulting in inpatient hospital stay, hospitalization due to syncopal episode.

Data from ClinicalTrials.gov NCT01357577 adverse events section.

Sponsor's own description

With this research, the investigators hope to learn if cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems with drugs or alcohol. In the past, people who had problems with drugs and alcohol were not given treatment for their PTSD. It was believed that PTSD treatment would get in the way of their drug and alcohol treatment. Now the investigators believe that the PTSD symptoms may make it harder to avoid using drugs and alcohol, so the investigators want to see if people can get treatment for both problems at the same time.

One hundred-sixty Veterans from 3 sites who have both PTSD and substance use disorders will be in the study. In order to know if the PTSD treatment is helpful, half of the Veterans in this study will receive PTSD treatment and half will continue to get their usual mental health and/or substance abuse treatment. Who gets which treatment will be decided by a random process. The investigators will then compare the 2 groups to see if there are differences in their PTSD symptoms.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Psychological therapies for post-traumatic stress disorder and comorbid substance use disorder.
   Roberts NP, Roberts PA, Jones N, Bisson JI. · · 2016 · cited 65× · PMID 27040448 · DOI 10.1002/14651858.cd010204.pub2