Trial Outcomes & Findings for Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance (NCT NCT00760994)

Last Updated: 2020-08-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

5 weeks

Results posted on

2020-08-10

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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).	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).	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.
Overall Study STARTED	29	31	20
Overall Study COMPLETED	25	27	17
Overall Study NOT COMPLETED	4	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).	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.
Overall Study Lost to Follow-up	4	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 - Experiential Accepatance (EA) n=27 Participants 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).	2 - Cognitive Restructuring (CR) n=31 Participants 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).	3 - Control n=20 Participants 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.	Total n=78 Participants Total of all reporting groups
Age, Continuous	43.93 years STANDARD_DEVIATION 12.34 • n=5 Participants	42.97 years STANDARD_DEVIATION 12.44 • n=7 Participants	46.95 years STANDARD_DEVIATION 8.75 • n=5 Participants	44.32 years STANDARD_DEVIATION 11.54 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	38 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Race/Ethnicity, Customized Black/African American	11 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White (non Hispanic)	10 Participants n=5 Participants	16 Participants n=7 Participants	7 Participants n=5 Participants	33 Participants n=4 Participants
Race/Ethnicity, Customized Multiple race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	27 Participants n=5 Participants	31 Participants n=7 Participants	20 Participants n=5 Participants	78 Participants n=4 Participants
Average Drinks per Day Assessed Using Daily Interactive Voice Response (IVR)	5.2 drinks per day STANDARD_DEVIATION 5.9 • n=5 Participants	2.7 drinks per day STANDARD_DEVIATION 3.5 • n=7 Participants	4.6 drinks per day STANDARD_DEVIATION 4.7 • n=5 Participants	4.0 drinks per day STANDARD_DEVIATION 4.8 • n=4 Participants
Average PTSD Scores per Day Assessed Using Daily Interactive Voice Response (IVR)	3.2 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	3.9 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	4.0 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	3.7 units on a scale STANDARD_DEVIATION 1.6 • n=4 Participants

PRIMARY outcome

Timeframe: 5 weeks

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

Outcome measures

Outcome measures
Measure	1 - Experiential Accepatance n=27 Participants 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).	2 - Cognitive Restructuring n=31 Participants 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).	3 - Control n=20 Participants 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.
Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR)	3.6 drinks per day Standard Deviation 5	1.8 drinks per day Standard Deviation 2.5	3.1 drinks per day Standard Deviation 3.7

SECONDARY outcome

Timeframe: 5 weeks

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

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.

Outcome measures

Outcome measures
Measure	1 - Experiential Accepatance n=27 Participants 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).	2 - Cognitive Restructuring n=31 Participants 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).	3 - Control n=20 Participants 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.
Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR)	2.7 units on a scale Standard Deviation 1.4	3.1 units on a scale Standard Deviation 1.8	3.0 units on a scale Standard Deviation 1.5

Adverse Events

1 - Experiential Accepatance (EA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 - Cognitive Restructuring (CR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3 - Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tracy Simpson, Ph.D.

VA Puget Sound Health Care System

Phone: 206-277-3337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place