Stress Disorders, Post-TraumaticPhase 3NCT01457391
Cognitive Behavioral Therapy (CBT) for Posttraumatic Stress Disorder (PTSD) in Community Addiction Treatment
A Phase 3 study testing Cognitive Behavioral Therapy, Individual Addiction Counseling and Treatment-as-usual in people with Stress Disorders, Post-Traumatic and Substance-Related Disorders, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
Trial summary
The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as delivered by routine addiction counselors in community treatment programs, and to compare CBT for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the primary outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
- What is being tested?
- Cognitive Behavioral Therapy, Individual Addiction Counseling 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
- 443 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Apr 2014
- 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
- At least 18 years old;
- Actively enrolled in outpatient addiction services and meets criteria for substance use disorder;
- Screened positive for PTSD (results of PCL show a likely Criterion A Traumatic Event and a score equal to or greater than 44);
- Willing and able to provide informed consent to participate in the study;
- Diagnosis of PTSD verified by the CAPS and total symptom score equal to or greater than 44;
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 to substance intoxication or detoxification and the person is currently stable, they are eligible);
- Medical and/or legal situations are unstable such that ability to participate in the full duration of the study seems unlikely.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Central Vermont Substance Abuse Services
Berlin Corners, Vermont, 05601
Brattleboro Retreat
Brattleboro, Vermont, 05762
Howard Center
Burlington, Vermont, 05401
Evergreen - Rutland Mental Health
Rutland, Vermont, 05701
About this study
Official title: A Stage II Efficacy Study of Cognitive Behavioral Therapy for PTSD in Community Addiction Treatment
The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as delivered by routine addiction counselors in community treatment programs, and to compare CBT for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the primary outcomes.
Read the detailed description
The main hypothesis being tested is that a cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) can improve treatment retention and outcomes for both posttraumatic stress and substance use disorders. The investigators have completed the Stage I Safety \& Practicality Study, Feasibility Study and Pilot Randomized Controlled Study (comparing CBT for PTSD to versus a control condition) and for all studies found that CBT for PTSD was safe and effective in reducing PTSD symptoms, improving retention, and in reducing substance use. The present study proposes to continue testing the hypotheses by evaluating and comparing the PTSD, retention and substance use outcomes resulting from CBT versus a control condition and to treatment as usual. This is termed a "Stage II Efficacy Study" of behavioral therapy development and requires comparing the investigational treatment (CBT) with a control treatment, within the context of addiction treatment-as-usual (intensive outpatient programs). This is a larger randomized controlled trial in response to the outcomes of the pilot trial. The proposed research will evaluate the efficacy of a relatively simple, manual-guided cognitive behavioral therapy (CBT) for PTSD. 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. Outpatients at each of 7 community addiction treatment programs, diagnosed with current PTSD will be randomly assigned to receive either: 1) CBT for PTSD in conjunction with standard treatment-as-usual (TAU) (n=76); 2) A manual-guided individual addiction counseling (IAC) adapted from the Individual Drug Counseling Manual in conjunction with TAU (n=76); or 3) TAU (n=76) without additional individual treatment for either PTSD or substance use disorders. Treatment will be delivered by frontline counselors from and onsite in the addiction treatment programs.
Our objective is to test the following specific hypotheses:
- Patients exposed to CBT for PTSD plus treatment-as-usual (TAU) will show significantly greater improvements in PTSD symptom severity relative to patients in the other two interventions (IAC+TAU and TAU alone) at both the three-month and six-month follow-ups. The IAC+TAU condition will show no greater reduction in PTSD symptom severity than the TAU condition at both the three-month and six-month follow-ups.
- Patients receiving the CBT for PTSD plus TAU will manifest equivalent reductions in substance use severity (drug and/or alcohol) to patients in the IAC+TAU intervention conditions at both the three-month and six-month follow-ups. CBT and IAC are both active treatments targeting substance use symptoms. The CBT+TAU and IAC+TAU condition patients will exhibit greater reductions in substance use than patients in the TAU condition at both the three-month and six-month follow-ups.
- Patients in the CBT condition will have better retention in the addiction treatment program relative to the IAC+TAU and TAU alone intervention conditions. IAC+TAU will have better retention in the addiction treatment program than TAU alone.
This study involves a three-group repeated measure design. Within the NIDA stage model, it is a randomized controlled trial with a matched-attention control condition. The investigators plan to examine the outcomes associated with the intervention versus control condition versus treatment-as-usual among patients receiving outpatient addiction treatment services (intensive outpatient programs). The investigators will employ assessments at baseline, three-month follow-up, and six-month follow-up. Eligible subjects will be randomly assigned to the study CBT therapy (plus addiction treatment-as-usual), the matched attention control condition (individual addiction counseling [IAC] plus addiction treatment-as-usual) or the addiction treatment-as-usual, and all will be followed for the research assessments regardless of whether they drop out of treatment early (whenever possible).
Patients admitted to the participating addiction treatment programs are routinely screened for PTSD using a brief self-report survey, the PTSD checklist (PCL). These forms are collected by clinical staff of teh treatment program and scored for PTSD diagnostic criteria. Patients scoring 44 or greater on the PCL are approached by a clinic staff about potential interest in the study. If they wish to learn more about the study, research coordinator (or on-site employee) is contacted, a suitable time arranged, and the patient 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 other commonly associated axis I DSM-IV diagnoses: Clinician Administered PTSD Scale (CAPS) and the Structured Clinical Interview for DSM-IV (SCID).
- 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)
- Treatment utilization: Recent Treatment Survey (RTS).
If the subject continues to meet criteria for PTDS (i.e. the CAPS interview confirms diagnosis of DSM-IV PTSD, with symptom severity at 44 or higher), he or she is randomized to receive the study CBT therapy, control condition (IAC), or treatment-as-usual (TAU).
Research assessments are then also conducted at three months and six months post baseline assessment. This follow-up assessments will consist of the same measures administered at baseline, with the exception of the SCID interview.
The investigators plan to randomize approximately 228 subjects in the study (76 to CBT, 76 to IAC, and 76 to TAU).
- Being tested
- Cognitive Behavioral Therapy, Individual Addiction Counseling, Treatment-as-usual
- Keywords
- 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.
Cognitive Behavioral TherapyBehavioural
Also called CBT for PTSD, Integrated Cognitive Behavioral Therapy, ICBT, CBT
Individual CBT, approx. 12 sessions, one session per week
Individual Addiction CounselingBehavioural
Also called IAC
Individual therapy, approx. 12 sessions, one session per week
Treatment-as-usualBehavioural
Also called TAU
Individual or group therapy, approx. 9-12 hours per week, multiple times a week for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy (CBT) is a non-exposure based manual-guided individual therapy. CBT for PTSD 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) Breathing retraining: A behavioral anxiety reduction skill; and 3) Cognitive restructuring: A cognitive approach and functional analysis of the link among emotions, cognitions and situations. Receives: Behavioral: Cognitive Behavioral Therapy |
| Individual Addiction Counseling | Active comparator | Individual Addiction Counseling (IAC) was adapted from the Individual Drug Counseling (IDC) manual used in the NIDA Cocaine Collaborative Study. IAC is a manual-guided treatment that focuses on substance use and history of use, consequences of use and denial, developing strategies for relapse prevention, and facilitation of connection with peer recovery support groups, specifically twelve step groups. The current adaptation of IAC modified the IDC manual by broadening the focus to include drugs other than cocaine, as well as alcohol. Receives: Behavioral: Individual Addiction Counseling |
| Treatment-as-usual | Active comparator | Treatment-as-usual (TAU) is the typical intensive outpatient (IOP) treatment that the patient would receive ordinarily at the identified addiction treatment program. Each TAU service operates using the American Society of Addiction Medicine criteria for Level II Intensive Outpatient services: 9-12 hours per week; group and individual sessions focused on motivation to address substance use, education about the consequences of substance use on major life areas, education about the disease concept and brain changes associated with addiction, exposure to information about social and family relationships and recovery, and relapse prevention skills. 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 PTSD symptom severity (Clinician Administered PTSD Scale (CAPS) score (30 day)) at 3-months and at 6-months
Measured: Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in positive toxicology screens (urine drug screen and breathalyzer) at 3-months and at 6-months
Measured: Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in drug and alcohol symptom severity (Addiction Severity Index (ASI)-Self Administered (30 day)) at 3-months and at 6-months
Measured: Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in frequency of substance use (Timeline Follow-Back (TLFB) Interview (90 day)) at 3-months and at 6-months
Measured: Baseline, 3-month, & 6-month follow-ups
Secondary outcomes (2)
Difference in treatment retention (continuation and completion of ICBT or IAC)
Measured: From date of treatment commencement until treatment completion, assessed up to approx. 12 weeks
Therapist adherence and competence (ICBT or IAC)
Measured: Duration of study intervention
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 startDec 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, 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
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark McGovern, Dartmouth-Hitchcock Medical Center
- Investigators
- Mark P. McGovern, Ph.D., Principal investigator, Geisel School of Medicine at Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457391
- Sponsor's protocol ID
- 5R01DA027650
- Other IDs
- 5R01DA027650
- Status last verified
- Feb 2015
- First submitted
- 4 Oct 2011
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meier A, McGovern MP, Lambert-Harris C, McLeman B, Franklin A, Saunders EC, Xie H. Adherence and competence in two manual-guided therapies for co-occurring substance use and posttraumatic stress disorders: clinician factors and patient outcomes. Am J Drug Alcohol Abuse. 2015;41(6):527-34. doi: 10.3109/00952990.2015.1062894. Epub 2015 Aug 18.
PubMed 26286351McGovern MP, Lambert-Harris C, Xie H, Meier A, McLeman B, Saunders E. A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder. Addiction. 2015 Jul;110(7):1194-204. doi: 10.1111/add.12943.
PubMed 25846251
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stage II Efficacy Study of Cognitive Behavioral Therapy for PTSD in Community Addiction Treatment
- ClinicalTrials.gov ID
- NCT01457391
- Acronym / sponsor ID
- 5R01DA027650
- Keywords
- cognitive behavioral therapy, addiction, posttraumatic stress disorder (PTSD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (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 phase of the study is to assess the efficacy of CBT for PTSD, as delivered by routine addiction counselors in community treatment programs, and to compare CBT for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the primary outcomes.
Detailed description
The main hypothesis being tested is that a cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) can improve treatment retention and outcomes for both posttraumatic stress and substance use disorders. The investigators have completed the Stage I Safety \& Practicality Study, Feasibility Study and Pilot Randomized Controlled Study (comparing CBT for PTSD to versus a control condition) and for all studies found that CBT for PTSD was safe and effective in reducing PTSD symptoms, improving retention, and in reducing substance use. The present study proposes to continue testing the hypotheses by evaluating and comparing the PTSD, retention and substance use outcomes resulting from CBT versus a control condition and to treatment as usual. This is termed a "Stage II Efficacy Study" of behavioral therapy development and requires comparing the investigational treatment (CBT) with a control treatment, within the context of addiction treatment-as-usual (intensive outpatient programs). This is a larger randomized controlled trial in response to the outcomes of the pilot trial. The proposed research will evaluate the efficacy of a relatively simple, manual-guided cognitive behavioral therapy (CBT) for PTSD. 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. Outpatients at each of 7 community addiction treatment programs, diagnosed with current PTSD will be randomly assigned to receive either: 1) CBT for PTSD in conjunction with standard treatment-as-usual (TAU) (n=76); 2) A manual-guided individual addiction counseling (IAC) adapted from the Individual Drug Counseling Manual in conjunction with TAU (n=76); or 3) TAU (n=76) without additional individual treatment for either PTSD or substance use disorders. Treatment will be delivered by frontline counselors from and onsite in the addiction treatment programs.
Our objective is to test the following specific hypotheses:
- Patients exposed to CBT for PTSD plus treatment-as-usual (TAU) will show significantly greater improvements in PTSD symptom severity relative to patients in the other two interventions (IAC+TAU and TAU alone) at both the three-month and six-month follow-ups. The IAC+TAU condition will show no greater reduction in PTSD symptom severity than the TAU condition at both the three-month and six-month follow-ups.
- Patients receiving the CBT for PTSD plus TAU will manifest equivalent reductions in substance use severity (drug and/or alcohol) to patients in the IAC+TAU intervention conditions at both the three-month and six-month follow-ups. CBT and IAC are both active treatments targeting substance use symptoms. The CBT+TAU and IAC+TAU condition patients will exhibit greater reductions in substance use than patients in the TAU condition at both the three-month and six-month follow-ups.
- Patients in the CBT condition will have better retention in the addiction treatment program relative to the IAC+TAU and TAU alone intervention conditions. IAC+TAU will have better retention in the addiction treatment program than TAU alone.
This study involves a three-group repeated measure design. Within the NIDA stage model, it is a randomized controlled trial with a matched-attention control condition. The investigators plan to examine the outcomes associated with the intervention versus control condition versus treatment-as-usual among patients receiving outpatient addiction treatment services (intensive outpatient programs). The investigators will employ assessments at baseline, three-month follow-up, and six-month follow-up. Eligible subjects will be randomly assigned to the study CBT therapy (plus addiction treatment-as-usual), the matched attention control condition (individual addiction counseling [IAC] plus addiction treatment-as-usual) or the addiction treatment-as-usual, and all will be followed for the research assessments regardless of whether they drop out of treatment early (whenever possible).
Patients admitted to the participating addiction treatment programs are routinely screened for PTSD using a brief self-report survey, the PTSD checklist (PCL). These forms are collected by clinical staff of teh treatment program and scored for PTSD diagnostic criteria. Patients scoring 44 or greater on the PCL are approached by a clinic staff about potential interest in the study. If they wish to learn more about the study, research coordinator (or on-site employee) is contacted, a suitable time arranged, and the patient 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 other commonly associated axis I DSM-IV diagnoses: Clinician Administered PTSD Scale (CAPS) and the Structured Clinical Interview for DSM-IV (SCID).
- 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)
- Treatment utilization: Recent Treatment Survey (RTS).
If the subject continues to meet criteria for PTDS (i.e. the CAPS interview confirms diagnosis of DSM-IV PTSD, with symptom severity at 44 or higher), he or she is randomized to receive the study CBT therapy, control condition (IAC), or treatment-as-usual (TAU).
Research assessments are then also conducted at three months and six months post baseline assessment. This follow-up assessments will consist of the same measures administered at baseline, with the exception of the SCID interview.
The investigators plan to randomize approximately 228 subjects in the study (76 to CBT, 76 to IAC, and 76 to TAU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy (CBT) is a non-exposure based manual-guided individual therapy. CBT for PTSD 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) Breathing retraining: A behavioral anxiety reduction skill; and 3) Cognitive restructuring: A cognitive approach and functional analysis of the link among emotions, cognitions and situations. |
| Individual Addiction Counseling | Active comparator | Behavioral: Individual Addiction CounselingIndividual Addiction Counseling (IAC) was adapted from the Individual Drug Counseling (IDC) manual used in the NIDA Cocaine Collaborative Study. IAC is a manual-guided treatment that focuses on substance use and history of use, consequences of use and denial, developing strategies for relapse prevention, and facilitation of connection with peer recovery support groups, specifically twelve step groups. The current adaptation of IAC modified the IDC manual by broadening the focus to include drugs other than cocaine, as well as alcohol. |
| Treatment-as-usual | Active comparator | Behavioral: Treatment-as-usualTreatment-as-usual (TAU) is the typical intensive outpatient (IOP) treatment that the patient would receive ordinarily at the identified addiction treatment program. Each TAU service operates using the American Society of Addiction Medicine criteria for Level II Intensive Outpatient services: 9-12 hours per week; group and individual sessions focused on motivation to address substance use, education about the consequences of substance use on major life areas, education about the disease concept and brain changes associated with addiction, exposure to information about social and family relationships and recovery, and relapse prevention skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old;
- Actively enrolled in outpatient addiction services and meets criteria for substance use disorder;
- Screened positive for PTSD (results of PCL show a likely Criterion A Traumatic Event and a score equal to or greater than 44);
- Willing and able to provide informed consent to participate in the study;
- Diagnosis of PTSD verified by the CAPS and total symptom score equal to or greater than 44;
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 to substance intoxication or detoxification and the person is currently stable, they are eligible);
- Medical and/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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBT for PTSD, Integrated Cognitive Behavioral Therapy, ICBT, CBTIndividual CBT, approx. 12 sessions, one session per week | Behavioural | Cognitive Behavioral Therapy |
| Individual Addiction CounselingAlso: IACIndividual therapy, approx. 12 sessions, one session per week | Behavioural | Individual Addiction Counseling |
| Treatment-as-usualAlso: TAUIndividual or group therapy, approx. 9-12 hours per week, multiple times a week for 2 months | Behavioural | Treatment-as-usual |
Primary outcome
Decrease from baseline in PTSD symptom severity (Clinician Administered PTSD Scale (CAPS) score (30 day)) at 3-months and at 6-months
Time frame: Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in positive toxicology screens (urine drug screen and breathalyzer) at 3-months and at 6-months
Time frame: Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in drug and alcohol symptom severity (Addiction Severity Index (ASI)-Self Administered (30 day)) at 3-months and at 6-months
Time frame: Baseline, 3-month, & 6-month follow-ups
Decrease from baseline in frequency of substance use (Timeline Follow-Back (TLFB) Interview (90 day)) at 3-months and at 6-months
Time frame: Baseline, 3-month, & 6-month follow-ups
2 secondary outcomes
Difference in treatment retention (continuation and completion of ICBT or IAC)
Time frame: From date of treatment commencement until treatment completion, assessed up to approx. 12 weeks
Therapist adherence and competence (ICBT or IAC)
Time frame: Duration of study intervention
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 16 Feb 2015.
- Derived from this study: PubMed 26286351Meier A, McGovern MP, Lambert-Harris C, McLeman B, Franklin A, Saunders EC, Xie H. Adherence and competence in two manual-guided therapies for co-occurring substance use and posttraumatic stress disorders: clinician factors and patient outcomes. Am J Drug Alcohol Abuse. 2015;41(6):527-34. doi: 10.3109/00952990.2015.1062894. Epub 2015 Aug 18.
- Derived from this study: PubMed 25846251McGovern MP, Lambert-Harris C, Xie H, Meier A, McLeman B, Saunders E. A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder. Addiction. 2015 Jul;110(7):1194-204. doi: 10.1111/add.12943.
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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
Geisel School of Medicine at Dartmouth College
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioral Therapy, Individual Addiction Counseling and Treatment-as-usual in people with Stress Disorders, Post-Traumatic and Substance-Related Disorders, run by Dartmouth-Hitchcock Medical Center at 4 sites 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 5 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 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 PTSD symptom severity (Clinician Administered PTSD Scale (CAPS) score (30 day)) at 3-months and at 6-months (time frame: Baseline, 3-month, & 6-month follow-ups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01457391, which also lists 2 linked publications.
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 16 Feb 2015.