Stress Disorder, Post-TraumaticPhase 3NCT01457404
Integrated Cognitive Behavioral Therapy (ICBT) for Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders
A Phase 3 study testing Integrated Cognitive Behavioral Therapy and Treatment-as-usual in people with Stress Disorder, Post-Traumatic and Substance-Related Disorders, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and practicality, feasibility and efficacy of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans population, as delivered by routine clinicians at the Veterans Affairs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorder, Post-Traumatic, Substance-Related Disorders
- What is being tested?
- Integrated Cognitive Behavioral Therapy and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OEF/OIF/OND Veteran status;
- Diagnosis of PTSD confirmed by the Clinician Administered PTSD Scale (CAPS) with a total symptom score of 44 or more;
- Diagnosis of a substance use disorder (abuse or dependence) and confirmed by the Structured Clinical Interview of DSM-IV Section E (SCID-E);
- Willing and able to provide informed consent;
Who cannot join
- Acute psychotic symptoms (however, persons with a psychotic disorder are eligible if their symptoms are stable and they are well connected with appropriate mental health services);
- Psychiatric hospitalization or suicide attempt in the past month (however, if the hospitalization or attempt was directly related substance intoxication or detoxification and ther person is currently stable, they are eligible);
- Medical or legal situations are unstable such that ability to participate in the full duration of the study seems unlikely.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Veterans Affairs Medical Center (PVAMC)
Providence, Rhode Island, 02908
About this study
Official title: Integrated Cognitive Behavioral Therapy for Co-Occurring PTSD and Substance Use Disorders
The purpose of this study is to assess the safety and practicality, feasibility and efficacy of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans population, as delivered by routine clinicians at the Veterans Affairs.
Read the detailed description
The proposed research will evaluate the safety and practicality, feasibility, and efficacy of a relatively simple, manual guided integrated cognitive behavioral therapy (ICBT). ICBT (a revised edition of what was formerly called cognitive behavioral therapy for posttraumatic stress disorder [CBT for PTSD]) has been designed and developed for delivery by counselors employed in community addiction treatment programs and offered in conjunction with standard community addiction treatment. The investigators have completed a Stage I Safety \& Practicality Study, Feasibility Study and Pilot Randomized Controlled Study (comparing ICBT versus a control condition) in community addiction treatment and for all studies found that ICBT was safe and effective in reducing PTSD symptoms, improving retention, and in reducing substance use. The present study proposes to conduct a Stage I study of ICBT among Operation Enduring Freedom (OEF) Operation Iraqi Freedom (OIF) and Operation New Dawn (OND) Veterans within the Veterans Affairs treatment setting. The investigators will modify the existing ICBT for testing in a VA setting, and use a combined individual and group modality.
There are 3 specific aims for this study, and hypotheses for each aim:
Aim 1: To test the feasibility of ICBT with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at 3- and 6-month follow-up (Stage I Phase I: Safety and practicality testing; Feasibility Study).
- This aim is to test the effect of ICBT on symptoms of PTSD and substance use disorders among returning OEF/OIF/OND Veterans seen in a VA clinic. ICBT will be tested with 16 Veterans who meet criteria for both PTSD and substance use disorder at the PTSD or SATP clinics. The investigators propose that ICBT will result in significant reductions in PTSD and substance use severity from baseline to follow-up assessment.
- Hypothesis 1: Participants receiving ICBT will have significant reductions in PTSD symptom severity as assessed by their Clinician Administered PTSD Scale (CAPS) score from baseline to a 6-month follow-up assessment.
- Hypothesis 2: Participants receiving ICBT will have significant reductions in substance use as assessed by their Addiction Severity Index (ASI) drug and alcohol severity composite scores from baseline to a 6-month follow-up assessment.
Aim 2: To revise the ICBT materials and protocol based on Stage I Phase I findings (Stage I Phase II).
-Based on experience and lessons learned in Stage I Phase I, the investigators will refine and improve the ICBT approach and study methods for teh Stage I Phase III randomized pilot trial.
Aim 3: To conduct a randomized controlled pilot trial comparing ICBT plus standard Substance Abuse Treatment Program (SATP) or PTSD care versus standard SATP or PTSD care alone, with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at post treatment and 3-month post treatment follow-up (Stage I Phase III: Randomized Pilot Trial).
- The efficacy of ICBT will be tested among 64 Veterans who screen positive for both disorders and are randomly assigned to either ICBT or standard treatment.
- Hypothesis 1: Participants receiving ICBT plus standard care will have greater reductions in PTSD symptoms, as assessed by their CAPS score from baseline to follow-up, than participants receiving standard care alone.
- Hypothesis 2: Participants receiving ICBT plus standard care will have greater reductions in substance use, as assessed by their ASI drug and alcohol severity composite scores from baseline to follow-up, as compared to participants receiving standard care alone.
Potential subjects will be receiving PTSD or substance use treatment services at the Providence Veterans Affairs Medical Center (PVAMC), and will be referred by clinicians in these respective clinics for participation in the study. Patients will be approached by the clinic staff about potential interest in the study. If they wish to learn more about the study, the research coordinator (an on-site employee) is contacted, a suitable time arranged, and the patient is engaged in the process of informed consent.
If consent is granted, the subjects completes the baseline assessment. The baseline assessment consists of measures gathered via interview by a member of the research team, self-administered surveys completed directly by the subject, and review of the subject's medical record to extract demographic, substance use, and treatment history information, as well as chart diagnoses.
The interview portion of the assessment consists of:
- Standardized interviews designed to assess PTSD and Axis I DSM-IV substance use disorders: Clinician Administered PTSD Scale (CAPS) and the Structured Clinical Interview for DSM-IV-TR, Patient Edition (SCID-I/P) Section E.
- A urine screen and breathalyzer to test for alcohol and other drugs.
- Standardized follow-back method for gathering data on recent alcohol and drug use: Time-line Follow-back Calendar (TLFB).
The self-administered portion of the assessment consists of measures designed to assess:
- Alcohol and drug use, as well as associated problems in other life areas such as medical, employment, legal, social, and psychiatric: Addiction Severity Index (ASI).
- Depression: Patient Health Questionnaire-9 (PHQ-9).
If the subject continues to meet criteria for PTSD (i.e. the CAPS interview confirms diagnosis of DSM-IV PTSD, with symptom severity at 44 or higher), he or she is eligible to participate. For Stage I Phase I, the patient would receive the ICBT therapy. For Stage I Phase III, the patient would be randomized to receive either the ICBT therapy plus standard treatment, or standard treatment only.
Research assessments are then also conducted at three months and six months post baseline assessment. This follow-up assessment will consist of the same measures administered at baseline, with the exception of the SCID interview.
The investigators plan to enroll approximately 16 subjects in the Stage I Phase I and to randomize approximately 64 subjects in the Stage I Phase III of the study. The subject outcome and program experiences with the protocol will be used in planning the subsequent federal grant application for a randomized controlled trial.
- Being tested
- Integrated Cognitive Behavioral Therapy, Treatment-as-usual
- Keywords
- integrated cognitive behavioral therapy, cognitive behavioral therapy, addiction, posttraumatic stress disorder (PTSD)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Cognitive Behavioral TherapyBehavioural
Also called ICBT, CBT for PTSD, CBT
Individual or group ICBT, approx. 12 sessions, one session per week
Treatment-as-usualBehavioural
Also called TAU
Individual or group therapy as usual within the SATP or PTSD clinics at the PVAMC
| Study group | Role | What they receive |
|---|---|---|
| Integrated Cognitive Behavioral Therapy | Experimental | Integrated Cognitive Behavioral Therapy (ICBT) is a non-exposure based, manual-guided individual or group therapy. ICBT consists of 3 learning and skill components designed to improve PTSD symptoms and substance use: 1) Patient education about PTSD and its relation to substance use and treatment; 2) Mindful relaxation: A behavioral anxiety reduction skill including centering and breathing techniques; and 3) Cognitive restructuring/flexible thinking: A cognitive approach and functional analysis of the link among emotions, cognitives and situations. Receives: Behavioral: Integrated Cognitive Behavioral Therapy |
| Treatment-as-usual | Active comparator | Treatment-as-usual (TAU) is the typical outpatient treatment that patients would receive ordinarily at the PVAMC Substance Abuse Treatment Program (SATP) or PTSD Clinic. Receives: Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease from baseline in Clinician Administered PTSD Scale (CAPS) score (PTSD symptom severity) at 3-months and at 6-months
Measured: Baseline, post-treatment, 3 months post treatment
Secondary outcomes (1)
Reduction from baseline in substance use severity (Addiction Severity Index [ASI]) at 3-months and at 6-months
Measured: Baseline, post treatment, 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorder, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Providence VA Medical Center, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark McGovern, Dartmouth-Hitchcock Medical Center
- Investigators
- Mark P. McGovern, Ph.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457404
- Sponsor's protocol ID
- 5R01DA030102
- Other IDs
- 5R01DA030102
- Status last verified
- Oct 2015
- First submitted
- 4 Oct 2011
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Cognitive Behavioral Therapy for Co-Occurring PTSD and Substance Use Disorders
- ClinicalTrials.gov ID
- NCT01457404
- Acronym / sponsor ID
- 5R01DA030102
- Keywords
- integrated cognitive behavioral therapy, cognitive behavioral therapy, addiction, posttraumatic stress disorder (PTSD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Brown University, Providence VA Medical Center, National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and practicality, feasibility and efficacy of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans population, as delivered by routine clinicians at the Veterans Affairs.
Detailed description
The proposed research will evaluate the safety and practicality, feasibility, and efficacy of a relatively simple, manual guided integrated cognitive behavioral therapy (ICBT). ICBT (a revised edition of what was formerly called cognitive behavioral therapy for posttraumatic stress disorder [CBT for PTSD]) has been designed and developed for delivery by counselors employed in community addiction treatment programs and offered in conjunction with standard community addiction treatment. The investigators have completed a Stage I Safety \& Practicality Study, Feasibility Study and Pilot Randomized Controlled Study (comparing ICBT versus a control condition) in community addiction treatment and for all studies found that ICBT was safe and effective in reducing PTSD symptoms, improving retention, and in reducing substance use. The present study proposes to conduct a Stage I study of ICBT among Operation Enduring Freedom (OEF) Operation Iraqi Freedom (OIF) and Operation New Dawn (OND) Veterans within the Veterans Affairs treatment setting. The investigators will modify the existing ICBT for testing in a VA setting, and use a combined individual and group modality.
There are 3 specific aims for this study, and hypotheses for each aim:
Aim 1: To test the feasibility of ICBT with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at 3- and 6-month follow-up (Stage I Phase I: Safety and practicality testing; Feasibility Study).
- This aim is to test the effect of ICBT on symptoms of PTSD and substance use disorders among returning OEF/OIF/OND Veterans seen in a VA clinic. ICBT will be tested with 16 Veterans who meet criteria for both PTSD and substance use disorder at the PTSD or SATP clinics. The investigators propose that ICBT will result in significant reductions in PTSD and substance use severity from baseline to follow-up assessment.
- Hypothesis 1: Participants receiving ICBT will have significant reductions in PTSD symptom severity as assessed by their Clinician Administered PTSD Scale (CAPS) score from baseline to a 6-month follow-up assessment.
- Hypothesis 2: Participants receiving ICBT will have significant reductions in substance use as assessed by their Addiction Severity Index (ASI) drug and alcohol severity composite scores from baseline to a 6-month follow-up assessment.
Aim 2: To revise the ICBT materials and protocol based on Stage I Phase I findings (Stage I Phase II).
-Based on experience and lessons learned in Stage I Phase I, the investigators will refine and improve the ICBT approach and study methods for teh Stage I Phase III randomized pilot trial.
Aim 3: To conduct a randomized controlled pilot trial comparing ICBT plus standard Substance Abuse Treatment Program (SATP) or PTSD care versus standard SATP or PTSD care alone, with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at post treatment and 3-month post treatment follow-up (Stage I Phase III: Randomized Pilot Trial).
- The efficacy of ICBT will be tested among 64 Veterans who screen positive for both disorders and are randomly assigned to either ICBT or standard treatment.
- Hypothesis 1: Participants receiving ICBT plus standard care will have greater reductions in PTSD symptoms, as assessed by their CAPS score from baseline to follow-up, than participants receiving standard care alone.
- Hypothesis 2: Participants receiving ICBT plus standard care will have greater reductions in substance use, as assessed by their ASI drug and alcohol severity composite scores from baseline to follow-up, as compared to participants receiving standard care alone.
Potential subjects will be receiving PTSD or substance use treatment services at the Providence Veterans Affairs Medical Center (PVAMC), and will be referred by clinicians in these respective clinics for participation in the study. Patients will be approached by the clinic staff about potential interest in the study. If they wish to learn more about the study, the research coordinator (an on-site employee) is contacted, a suitable time arranged, and the patient is engaged in the process of informed consent.
If consent is granted, the subjects completes the baseline assessment. The baseline assessment consists of measures gathered via interview by a member of the research team, self-administered surveys completed directly by the subject, and review of the subject's medical record to extract demographic, substance use, and treatment history information, as well as chart diagnoses.
The interview portion of the assessment consists of:
- Standardized interviews designed to assess PTSD and Axis I DSM-IV substance use disorders: Clinician Administered PTSD Scale (CAPS) and the Structured Clinical Interview for DSM-IV-TR, Patient Edition (SCID-I/P) Section E.
- A urine screen and breathalyzer to test for alcohol and other drugs.
- Standardized follow-back method for gathering data on recent alcohol and drug use: Time-line Follow-back Calendar (TLFB).
The self-administered portion of the assessment consists of measures designed to assess:
- Alcohol and drug use, as well as associated problems in other life areas such as medical, employment, legal, social, and psychiatric: Addiction Severity Index (ASI).
- Depression: Patient Health Questionnaire-9 (PHQ-9).
If the subject continues to meet criteria for PTSD (i.e. the CAPS interview confirms diagnosis of DSM-IV PTSD, with symptom severity at 44 or higher), he or she is eligible to participate. For Stage I Phase I, the patient would receive the ICBT therapy. For Stage I Phase III, the patient would be randomized to receive either the ICBT therapy plus standard treatment, or standard treatment only.
Research assessments are then also conducted at three months and six months post baseline assessment. This follow-up assessment will consist of the same measures administered at baseline, with the exception of the SCID interview.
The investigators plan to enroll approximately 16 subjects in the Stage I Phase I and to randomize approximately 64 subjects in the Stage I Phase III of the study. The subject outcome and program experiences with the protocol will be used in planning the subsequent federal grant application for a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Cognitive Behavioral Therapy | Experimental | Behavioral: Integrated Cognitive Behavioral TherapyIntegrated Cognitive Behavioral Therapy (ICBT) is a non-exposure based, manual-guided individual or group therapy. ICBT consists of 3 learning and skill components designed to improve PTSD symptoms and substance use: 1) Patient education about PTSD and its relation to substance use and treatment; 2) Mindful relaxation: A behavioral anxiety reduction skill including centering and breathing techniques; and 3) Cognitive restructuring/flexible thinking: A cognitive approach and functional analysis of the link among emotions, cognitives and situations. |
| Treatment-as-usual | Active comparator | Behavioral: Treatment-as-usualTreatment-as-usual (TAU) is the typical outpatient treatment that patients would receive ordinarily at the PVAMC Substance Abuse Treatment Program (SATP) or PTSD Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- OEF/OIF/OND Veteran status;
- Diagnosis of PTSD confirmed by the Clinician Administered PTSD Scale (CAPS) with a total symptom score of 44 or more;
- Diagnosis of a substance use disorder (abuse or dependence) and confirmed by the Structured Clinical Interview of DSM-IV Section E (SCID-E);
- Willing and able to provide informed consent;
Key exclusion criteria (3 listed)
- Acute psychotic symptoms (however, persons with a psychotic disorder are eligible if their symptoms are stable and they are well connected with appropriate mental health services);
- Psychiatric hospitalization or suicide attempt in the past month (however, if the hospitalization or attempt was directly related substance intoxication or detoxification and ther person is currently stable, they are eligible);
- Medical or legal situations are unstable such that ability to participate in the full duration of the study seems unlikely.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Cognitive Behavioral TherapyAlso: ICBT, CBT for PTSD, CBTIndividual or group ICBT, approx. 12 sessions, one session per week | Behavioural | Integrated Cognitive Behavioral Therapy |
| Treatment-as-usualAlso: TAUIndividual or group therapy as usual within the SATP or PTSD clinics at the PVAMC | Behavioural | Treatment-as-usual |
Primary outcome
Decrease from baseline in Clinician Administered PTSD Scale (CAPS) score (PTSD symptom severity) at 3-months and at 6-months
Time frame: Baseline, post-treatment, 3 months post treatment
1 secondary outcome
Reduction from baseline in substance use severity (Addiction Severity Index [ASI]) at 3-months and at 6-months
Time frame: Baseline, post treatment, 3 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P. McGovern, Ph.D. principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Integrated Cognitive Behavioral Therapy and Treatment-as-usual in people with Stress Disorder, Post-Traumatic and Substance-Related Disorders, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease from baseline in Clinician Administered PTSD Scale (CAPS) score (PTSD symptom severity) at 3-months and at 6-months (time frame: Baseline, post-treatment, 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2015.