Integrated Alcohol Disorder and PTSD Treatment

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01601067
• Collaborator: (none)
• Enrollment: 168
• Location: 1
• Arms: 2
• Actual Duration (Months): 62.2
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

Comorbidity of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common. Currently available treatments often do not lead to sustained recovery from these disorders, possibly because they typically do not include exposure therapy which is considered best practice treatments for PTSD. This study compares exposure-based integrated treatment to integrated coping skills psychotherapy (a well disseminated practice) for comorbid AD and PTSD with the hypothesis that exposure therapy will allow those with PTSD to better sustain PTSD symptom reduction and reduction in alcohol use. The aim of this grant is to change common treatment practices for comorbid AD and PTSD by increasing the availability of evidence-based PTSD treatment for those with AD.

Condition or Disease	Intervention/Treatment	Phase
PTSD; Alcoholism	Behavioral: Integrated Prolonged Exposure Therapy; Behavioral: Seeking Safety	Phase 2

Detailed Description

Objectives. Co-occurrence of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common. Research supports exposure therapy as the front line treatment for PTSD as this approach is most likely to lead to sustained recovery from the disorder. However, individuals with AD are generally not offered exposure therapies because of beliefs that exposure would lead to engagement in greater alcohol use and other dangerous behaviors. Most research and clinical treatment for comorbid AD and PTSD (AD/PTSD) have involved coping skills based therapies that have generally not shown sustained reductions in alcohol use and PTSD symptoms. A growing body of evidence suggests these individuals with AD/PTSD are able to handle and benefit from exposure. This proposed trial will compare an integrated exposure psychotherapy to an integrated coping skills psychotherapy for the treatment of AD/PTSD. In addition, mechanisms of change for Veterans with AD/PTSD in both treatment conditions, including therapy process variables, changes in negative affect, and sleep problems, will be explored. This project addresses a critical barrier in the field - the widely held belief that individuals with AD and PTSD cannot tolerate exposure therapy, although it is the best practice treatment for PTSD. The fundamental rationale is to improve the evidence base that informs how patients with AD/PTSD can attain sustained recovery. The investigators propose a randomized controlled trial to evaluate an integrated exposure-based treatment for concurrent AD and PTSD. The primary aim will be to conduct a randomized controlled trial to evaluate the effects of integrated exposure psychotherapy when compared to a present-focused coping skills based intervention (Seeking Safety; SS) in 148 male and female Veterans who have AD and PTSD. The hypotheses are that at post-treatment both groups will show reductions in alcohol use, but the integrated exposure group will demonstrate greater reductions in PTSD symptoms than SS. At 5- and 8-month post-baseline follow-up, the integrated exposure group will have significantly fewer percent drinking days and fewer PTSD symptoms than SS. In addition, mechanisms of change in both treatment conditions will be examined.

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Integrated Alcohol Disorder and PTSD Treatment
• Actual Study Start Date: Jan 21, 2013
• Actual Primary Completion Date: Mar 30, 2018
• Actual Study Completion Date: Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Integrated Prolonged Exposure Therapy Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)	Behavioral: Integrated Prolonged Exposure Therapy; Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.; Other Names: I-PE
Active Comparator: Arm 2: Seeking Safety Seeking Safety	Behavioral: Seeking Safety; Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.; Other Names: SS

Outcome Measures

Primary Outcome Measures

1. Clinician Administered PTSD Scale (CAPS) [baseline through 6 month follow-up]

   The CAPS-5 (score range, 0-80, with 0 indicating no PTSD symptoms and 80 indicating extreme ratings across all symptoms), a 30-item structured interview considered to be the criterion standard for PTSD, was the primary measure of PTSD symptoms and diagnosis. Diagnosis was determined using the rule of a severity score of 2 or higher, which follows DSM-5 PTSD criteria.

Secondary Outcome Measures

1. Timeline Follow-Back Procedure (TLFB) for Alcohol Use [baseline to 6-month follow-up]

   Frequency and quantity of alcohol use were assessed using the Timeline Follow-Back, a calendar-assisted structured clinical interview that displays good psychometric properties. The PHDD was calculated by dividing the number of days in which 5 or more drinks for men or 4 or more drinks for women were consumed by the total number of days in the reference period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Veterans who were victims of psychological trauma that occurred in childhood or adulthood.

• At least one month post-trauma.

• Age 18 or older.

• Meeting diagnostic criteria for current alcohol dependence and PTSD.

• Literate in English.

• Intend to stay in San Diego during study participation.

• Willing to attend psychotherapy and measurement sessions.

• Willing to stay cut down alcohol use significantly during treatment.

Exclusion Criteria:

• Moderate or severe cognitive impairment on the Brief Neuropsychological (NP) Assessment Battery as this may interfere with ability to benefit from treatment.

• Acutely suicidal individuals will be referred for more appropriate treatment.

• Histories of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress.

• Individuals who use intravenous drugs will be excluded.

• Participants who do not have adequate memory of the trauma will be excluded because such memory is necessary for exposure therapy.

• Only Veterans residing within 50 miles of the site will be included.

• Those with life threatening or unstable medical illness, documented neurological disorder, or inability to read will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA San Diego Healthcare System, San Diego, CA	San Diego	California	United States	92161

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Sonya B. Norman, PhD, VA San Diego Healthcare System, San Diego, CA

Study Documents (Full-Text)

• Study Protocol - Apr 14, 2016
• Statistical Analysis Plan - Sep 3, 2011

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01601067
• Other Study ID Numbers: NURA-011-11F
• First Posted: May 17, 2012
• Last Update Posted: Aug 8, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: posttraumatic stress disorder; psychotherapy; alcoholism
• Additional relevant MeSH terms: Alcoholism; Alcohol-Related Disorders

Study Results

Participant Flow

Recruitment Details	Participants contacted our study in response to 1) flyers posted in VA mental health, primary care, and alcohol and substance use treatment programs; 2) from advertisements in print and web-based media; and 3) by VA primary care, SAMI, PTSD, and other psychiatry clinics
Pre-assignment Detail	Enrolled participants were excluded from the study for the following reasons: 27 did not meet inclusion criteria; 15 did not complete intake or did not return for intake following informed consent;5 refused research after consent; 2 had travel or logistical constrains.

Arm/Group Title	Arm 1: Integrated Prolonged Exposure Therapy	Arm 2: Seeking Safety
Arm/Group Description	Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder) Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.	Seeking Safety Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
Period Title: Overall Study
STARTED	63	56
COMPLETED	30	34
NOT COMPLETED	33	22

Baseline Characteristics

Arm/Group Title	Arm 1: Integrated Prolonged Exposure Therapy	Arm 2: Seeking Safety	Total
Arm/Group Description	Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder) Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.	Seeking Safety Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.	Total of all reporting groups
Overall Participants	63	56	119
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.2 (13.5)	39.7 (11.3)	41.6 (12.6)
Sex: Female, Male (Count of Participants)
Female	7 11.1%	5 8.9%	12 10.1%
Male	56 88.9%	51 91.1%	107 89.9%
Race/Ethnicity, Customized (Count of Participants)
White	41 65.1%	37 66.1%	78 65.5%
Black	8 12.7%	8 14.3%	16 13.4%
Asian	3 4.8%	3 5.4%	6 5%
Other	11 17.5%	7 12.5%	18 15.1%
Unavailable	0 0%	1 1.8%	1 0.8%
Region of Enrollment (Count of Participants)
United States	63 100%	56 100%	119 100%

Outcome Measures

1. Primary Outcome

Title	Clinician Administered PTSD Scale (CAPS)
Description	The CAPS-5 (score range, 0-80, with 0 indicating no PTSD symptoms and 80 indicating extreme ratings across all symptoms), a 30-item structured interview considered to be the criterion standard for PTSD, was the primary measure of PTSD symptoms and diagnosis. Diagnosis was determined using the rule of a severity score of 2 or higher, which follows DSM-5 PTSD criteria.
Time Frame	baseline through 6 month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Integrated Prolonged Exposure Therapy	Arm 2: Seeking Safety
Arm/Group Description	Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder) Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.	Seeking Safety Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
Measure Participants	63	56
Baseline	43.2	42.1
After Treatment	25.8	32.9
3 month follow-up	26.4	31.0
6 month follow-up	22.5	29.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Integrated Prolonged Exposure Therapy, Arm 2: Seeking Safety
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.002
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Timeline Follow-Back Procedure (TLFB) for Alcohol Use
Description	Frequency and quantity of alcohol use were assessed using the Timeline Follow-Back, a calendar-assisted structured clinical interview that displays good psychometric properties. The PHDD was calculated by dividing the number of days in which 5 or more drinks for men or 4 or more drinks for women were consumed by the total number of days in the reference period.
Time Frame	baseline to 6-month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Integrated Prolonged Exposure Therapy	Arm 2: Seeking Safety
Arm/Group Description	Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder) Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.	Seeking Safety Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
Measure Participants	63	56
% Days heavy drinking - baseline	52.5	50.4
% Days heavy drinking -After treatment	21.0	17.4
% Days heavy drinking - 3 month follow up	14.2	15.0
% Days heavy drinking - 6-month follow-up	20.2	19.9
% Days abstinent - baseline	34.3	31.2
% Days abstinent - After treatment	67.5	63.1
% Days abstinent - 3-month follow up	65.6	68.4
% Days abstinent - 6-month follow-up	66.2	64.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1: Integrated Prolonged Exposure Therapy, Arm 2: Seeking Safety
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.91
	Comments	heavy drinking days
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Four years and seven months
Arm/Group Title	Arm 1: Integrated Prolonged Exposure Therapy		Arm 2: Seeking Safety
Arm/Group Description	Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder) Integrated Prolonged Exposure Therapy: Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.		Seeking Safety Seeking Safety: Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
All Cause Mortality
	Arm 1: Integrated Prolonged Exposure Therapy		Arm 2: Seeking Safety
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/56 (0%)
Serious Adverse Events
	Arm 1: Integrated Prolonged Exposure Therapy		Arm 2: Seeking Safety
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/63 (3.2%)		0/56 (0%)
Psychiatric disorders
hospitalization for alcohol intoxication and mood stabilization	2/63 (3.2%)	2	0/56 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm 1: Integrated Prolonged Exposure Therapy		Arm 2: Seeking Safety
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/56 (0%)

Limitations/Caveats

- Mostly male veteran sample

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.