PTSD, Substance Addiction
Conditions
Keywords
Treatment, PTSD, Addiction
Brief summary
The investigators are examining different treatment strategies of helping patients with PTSD and addiction.
Detailed description
The investigators hypothesize that Veterans in the integrated conditions will show greater reductions in substance abuse and PTSD symptom severity at the end of treatment and at 6 and 9 month follow-ups. The investigators further hypothesize that offering Veterans Prolonged Exposure (PE) at the onset of treatment in the integrated condition will leader to greater retention and satisfaction than in the sequential treatment design.
Interventions
BEHAVIORALProlonged Exposure
Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders.
BEHAVIORALMotivational Enhancement Therapy
Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female Persian Gulf Era veterans between 18-65 years old. Older individuals are unlikely to have served in Iraq or Afghanistan. * Current diagnosis of PTSD (symptom duration \> 3 months) with clinically significant trauma-related symptoms, as indicated by a score of at least 50 on the PCL * Current abuse or dependence on alcohol, stimulants such as cocaine, opioids, including prescription opioids or benzodiazepines. Subjects must report using on average at least 10 out of 30 days prior to signing consent. Of note: subjects can be abusing or dependent upon nicotine or marijuana but these will not be considered sufficient for inclusion * Provides informed consent * Speaks and reads English
Exclusion criteria
* Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment * Meets current DSM-IV criteria for bipolar affective disorder, schizophrenia or any psychotic disorder * Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease * History of moderate or severe traumatic brain injury (TBI) * Participation in Prolonged Exposure Therapy in the last 6 months. * Initiation of a new psychotherapy program in the last 2 months. * Active participation in a formal addiction treatment program. Actively engaged is defined as any visit in the program in the prior month and pending future appointments for the treatment of addictions * Change in psychotropic medication in the 1 month prior to treatment except for the use of oxazepam for alcohol detoxification or a taper of a previously used benzodiazepine. * Therapeutic use of a benzodiazepine greater than the equivalent of more than 40 mg of diazepam (see chart) at the time of randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptoms | 16 weeks | PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms. |
| Drinking Outcome | 16 weeks | Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Integrated Care Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment. | 95 |
| Sequential Treatment Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun. | 88 |
| Total | 183 |
Baseline characteristics
| Characteristic | Integrated Care | Sequential Treatment | Total |
|---|---|---|---|
| Age, Continuous | 44.1 years STANDARD_DEVIATION 13.1 | 43.8 years STANDARD_DEVIATION 13 | 44.1 years STANDARD_DEVIATION 13 |
| Gender Female | 5 Participants | 9 Participants | 14 Participants |
| Gender Male | 90 Participants | 79 Participants | 169 Participants |
| Percent days of heavy drinking | 51.7 percent days heavy drinking STANDARD_DEVIATION 29.5 | 56.0 percent days heavy drinking STANDARD_DEVIATION 29.6 | 53.8 percent days heavy drinking STANDARD_DEVIATION 29.6 |
| PTSD Checklist score | 62.5 units on a scale STANDARD_DEVIATION 11.3 | 63.6 units on a scale STANDARD_DEVIATION 10.3 | 63.0 units on a scale STANDARD_DEVIATION 10.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 42 Participants | 91 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 37 Participants | 38 Participants | 75 Participants |
| Region of Enrollment United States | 95 participants | 88 participants | 183 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 95 | 0 / 88 |
| serious Total, serious adverse events | 0 / 95 | 0 / 88 |
Outcome results
Primary
Drinking Outcome
Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.
Time frame: 16 weeks
Population: The number of subjects available for this measure are greater than the PTSD outcome as drinking outcomes can be obtained at anytime and thus some participants provided data at the post study evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Integrated Conditions | Drinking Outcome | 48.8 percent days ofheavy drinking | Standard Deviation 38.4 |
| Arm 2 Sequential Therapy | Drinking Outcome | 40.6 percent days ofheavy drinking | Standard Deviation 34.6 |
Primary
PTSD Symptoms
PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Integrated Conditions | PTSD Symptoms | 55.5 units on a scale | Standard Deviation 17.6 |
| Arm 2 Sequential Therapy | PTSD Symptoms | 54.1 units on a scale | Standard Deviation 17.9 |