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Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance

Reducing Alcohol Use & PTSD w/ Cognitive Restructuring & Experiential Acceptance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00760994
Acronym
COPE
Enrollment
80
Registered
2008-09-26
Start date
2009-01-31
Completion date
2012-08-31
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, Stress Disorders, Post-Traumatic

Keywords

Alcohol, Alcoholic, Alcoholism, Post-traumatic stress disorder, PTSD, Experiential acceptance, Mindfulness, Meditation, Meditate, Cognitive restructuring, Cognitive, Behavioral, Therapy, Treatment, Study, Intervention

Brief summary

The purpose of this study is to determine whether an experiential acceptance therapy intervention is effective in the treatment of alcohol dependency and post-traumatic stress disorder (PTSD) symptoms in individuals who suffer from PTSD.

Detailed description

Alcohol dependence (AD) afflicts nearly 14% of the population (Kessler et al., 1994; Kessler et al., 1997; Regier et al., 1990), and has a chronic and relapsing course (Brownell, Marlatt, Litchenstein, & Wilson, 1986). Negative emotional states have consistently been found to maintain alcohol use disorders (AUDs; Cooney, Litt, Morse, Bauer, & Gaupp, 1997; Litt, Cooney, Kadden, & Gaupp, 1990; Rubonis et al., 1994) and increase the risk of relapse following AUD treatment (Cooney et al., 1997). This relationship is particularly robust among individuals with co-morbid psychiatric disorders, such as posttraumatic stress disorder (PTSD; Coffey et al., 2002; Sharkansy, Brief, Peirce, Meehan, & Mannix, 1999; Tate, Brown, Unrod, & Ramo, 2004; Waldrop, Back, Verduin, & Brady, in press). Likewise, alcohol use may be maintained by a desire to facilitate or prolong positive emotional states (Cooper, Frone, Russell, & Mudar, 1992; Simpson, 2003). Many psychological interventions for AUDs, most notably the majority of cognitive-behavioral treatment (CBT) packages, have thus focused on the development of coping skills to prevent relapse in response to such triggers, and have been demonstrated to be at least moderately effective in promoting abstinence (Miller & Wilbourne, 2002). However, attempts to specify the active ingredients of CBT for AD have been disappointing and most studies examining potential mechanisms of change have failed to find the expected relationships (Longabaugh et al., 2005; Morgenstern & Longabaugh, 2000). The lack of empirical evidence substantiating coping skills as a mechanism of change for CBT (Morgenstern & Longabaugh, 2000) may be due, in part, to the lack of specificity in coping skill interventions. Broadly speaking, two primary foci of coping skill interventions for AUD are 1) increasing cognitive techniques focused on challenging and changing thought patterns, or 2) increasing experiential acceptance by fostering an accepting stance towards internal states, such as through urge surfing (Kadden et al., 1992). These two coping skill approaches (cognitive restructuring and experiential acceptance) likely lead to reduced alcohol use through different pathways. Theoretically, experiential acceptance approaches suggest that the mechanism of change in decreasing alcohol use is increased willingness toward internal experience (e.g., emotions, thoughts, sensations), whereas cognitive restructuring approaches suggest that decreased alcohol use results from decreases in negative appraisals brought about by challenging and changing thought patterns. However, this has yet to be systematically evaluated.

Interventions

BEHAVIORALExperiential acceptance

The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004).

The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992).

OTHERNo-intervention control: Nutrition information

The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
VA Puget Sound Health Care System
CollaboratorFED
University of Washington
CollaboratorOTHER
Seattle Institute for Biomedical and Clinical Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age at least 18 years * current DSM-IV diagnosis of alcohol dependence (AD) with some alcohol use in the last month * current DSM-IV diagnosis of post-traumatic stress disorder (PTSD) * capacity to provide informed consent * English fluency * no planned absences that they would be unable to complete 6 weeks of daily monitoring and study sessions * access to a telephone * desire to decrease or stop alcohol drinking behavior

Exclusion criteria

* a history of delirium tremens * seizures, in order to ensure that participants will be medically safe to decrease alcohol use * opiate abuse or dependence use or chronic treatment with any opioid- containing medications during the previous month * currently taking or planning to start taking either antabuse or naltrexone (due to their pharmacological impact on alcohol cravings and use) * exhibits signs or symptoms of alcohol withdrawal at the time of initial consent * acutely suicidal with intent/plan or present an imminent danger to others * a current psychotic disorder For ethical reasons and because of the preliminary nature of this study, participants may be in ongoing substance abuse or mental health treatment (MH) or may initiate counseling or medications (other than those noted in

Design outcomes

Primary

MeasureTime frameDescription
Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)5 weeksAfter the treatment had been started and for five weeks following the treatment, participants reported their alcohol use on the previous day using the IVR technology. Each participant's data were added and averaged to get the average drinks per day of each treatment group (EA and CR) and control group. The higher the number, the more drinks were consumed per day. Possible minimum value: 0. Possible maximum value: unlimited.

Secondary

MeasureTime frameDescription
Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)5 weeksPTSD scores were collected via the IVR technology after the treatment has been started and for the next five weeks. Participants completed an abbreviated version of PCL-C (PTSD Checklist-Civilian Version) daily. Three re-experiencing symptoms, 2 avoidance symptoms, 3 emotional numbing symptoms, & 4 four hyperarousal symptoms were included. Participants rated each symptom from 0 (not at all) to 8 (all the time). The higher the score, the more intense their PTSD symptoms. The minimum & maximum possible scores were 0 & 96, respectively. Each participant's data were added and averaged to get the average PTSD scores per day of each treatment group (EA and CR) and control group.

Countries

United States

Participant flow

Recruitment details

Participant who wanted to decrease their alcohol use were recruited through newspaper advertisements & flyers. One hundred thirty two individuals were consented, 92 out of the 132 consented individuals were eligible, and 80 were randomized. Seventy eight participants received an intervention.

Pre-assignment details

Out of 132 individuals who provided written consent, 40 were ineligible: 1. 10 individuals didn't use alcohol or have an alcohol diagnosis. 2. 16 individuals didn't have PTSD. 3. 4 individuals used an opiate or methamphetamine. 4. 7 individuals had a bipolar disorder or psychotic. 5. 3 individuals had reasons other than the ones above.

Participants by arm

ArmCount
1 - Experiential Accepatance (EA)
Experiential acceptance Experiential acceptance: The experiential acceptance coping condition will focus on changing one's relationship to one's internal events by learning to remain in contact with negative and positive thoughts and feelings and cravings as they are, without defense or judgment or attempting to cling to them (Eifert & Forsyth, 2005; Hayes, Strosahl, & Wilson, 1999; Kadden et al., 1992; Levitt, Brown, Orsillo, & Barlow, 2004).
27
2 - Cognitive Restructuring (CR)
Cognitive restructuring Cognitive restructuring: The cognitive restructuring coping condition will focus on how to change the content and frequency of internal events by changing one's thinking patterns (Kadden et al., 1992).
31
3 - Control
No-intervention control: Nutrition information No-intervention control: Nutrition information: The no-intervention condition will be taught the plate method, a nutritional servings guideline, which will have no content related to AUD or PTSD, in order to control for time and contact with a research assistant.
20
Total78

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up443

Baseline characteristics

Characteristic1 - Experiential Accepatance (EA)Total3 - Control2 - Cognitive Restructuring (CR)
Age, Continuous43.93 years
STANDARD_DEVIATION 12.34
44.32 years
STANDARD_DEVIATION 11.54
46.95 years
STANDARD_DEVIATION 8.75
42.97 years
STANDARD_DEVIATION 12.44
Average Drinks per Day Assessed Using Daily Interactive Voice Response (IVR)5.2 drinks per day
STANDARD_DEVIATION 5.9
4.0 drinks per day
STANDARD_DEVIATION 4.8
4.6 drinks per day
STANDARD_DEVIATION 4.7
2.7 drinks per day
STANDARD_DEVIATION 3.5
Average PTSD Scores per Day Assessed Using Daily Interactive Voice Response (IVR)3.2 units on a scale
STANDARD_DEVIATION 1.6
3.7 units on a scale
STANDARD_DEVIATION 1.6
4.0 units on a scale
STANDARD_DEVIATION 1.4
3.9 units on a scale
STANDARD_DEVIATION 1.6
Race/Ethnicity, Customized
Asian
0 Participants1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Black/African American
11 Participants34 Participants12 Participants11 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants3 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Multiple race
1 Participants2 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Native American
1 Participants2 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Other
2 Participants3 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White (non Hispanic)
10 Participants33 Participants7 Participants16 Participants
Region of Enrollment
United States
27 Participants78 Participants20 Participants31 Participants
Sex: Female, Male
Female
12 Participants38 Participants10 Participants16 Participants
Sex: Female, Male
Male
15 Participants40 Participants10 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 310 / 20
other
Total, other adverse events
0 / 270 / 310 / 20
serious
Total, serious adverse events
0 / 270 / 310 / 20

Outcome results

Primary

Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)

After the treatment had been started and for five weeks following the treatment, participants reported their alcohol use on the previous day using the IVR technology. Each participant's data were added and averaged to get the average drinks per day of each treatment group (EA and CR) and control group. The higher the number, the more drinks were consumed per day. Possible minimum value: 0. Possible maximum value: unlimited.

Time frame: 5 weeks

Population: Data were analyzed using Generalized Estimating Equation (GEE) models.

ArmMeasureValue (MEAN)Dispersion
1 - Experiential AccepatanceAverage Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)3.6 drinks per dayStandard Deviation 5
2 - Cognitive RestructuringAverage Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)1.8 drinks per dayStandard Deviation 2.5
3 - ControlAverage Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)3.1 drinks per dayStandard Deviation 3.7
Secondary

Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)

PTSD scores were collected via the IVR technology after the treatment has been started and for the next five weeks. Participants completed an abbreviated version of PCL-C (PTSD Checklist-Civilian Version) daily. Three re-experiencing symptoms, 2 avoidance symptoms, 3 emotional numbing symptoms, & 4 four hyperarousal symptoms were included. Participants rated each symptom from 0 (not at all) to 8 (all the time). The higher the score, the more intense their PTSD symptoms. The minimum & maximum possible scores were 0 & 96, respectively. Each participant's data were added and averaged to get the average PTSD scores per day of each treatment group (EA and CR) and control group.

Time frame: 5 weeks

Population: Data were analyzed using Generalized Estimating Equation (GEE) models.

ArmMeasureValue (MEAN)Dispersion
1 - Experiential AccepatanceAverage Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)2.7 units on a scaleStandard Deviation 1.4
2 - Cognitive RestructuringAverage Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)3.1 units on a scaleStandard Deviation 1.8
3 - ControlAverage Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)3.0 units on a scaleStandard Deviation 1.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026