Other (or Unknown) Substance Use DisordersPhase 2SUD/AnxNCT02667015
Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity
A Phase 2 study testing Psychotherapy (Anxiety Sensitivity Intervention) in people with Other (or Unknown) Substance Use Disorders, run by Hartford Hospital at 1 site in United States.
Trial summary
The aim of the current study is to develop and pilot test an anxiety sensitivity-based intervention for co-occurring substance use disorders (SUDs) and anxiety. Research questions include determining whether a broadly-applicable AS-based intervention can significantly decrease both substance misuse and anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other (or Unknown) Substance Use Disorders
- What is being tested?
- Psychotherapy (Anxiety Sensitivity Intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to May 2015
- Phase
- Phase 2
- 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
- score higher than 25 (established clinical cutoff) on the Anxiety Sensitivity Index (ASI; Peterson \& Plehn, 1999)
- meet the DSM diagnostic criteria for current substance abuse or psychological dependence
Who cannot join
- active psychosis, suicidality, mania, or current physiological withdrawal symptoms that necessitate medical detoxification; no substance use in the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Living/Hartford Hospital
Hartford, Connecticut, 06061
About this study
The aim of the current study is to develop and pilot test an anxiety sensitivity-based intervention for co-occurring substance use disorders (SUDs) and anxiety. Research questions include determining whether a broadly-applicable AS-based intervention can significantly decrease both substance misuse and anxiety. Secondary aims include examining the impact of this intervention on general functioning and depressive/anxious symptoms. In phase I, an initial pilot was conducted to examine the feasibility, safety, and patient satisfaction with the protocol, and to estimate potential efficacy of the protocol. In phase II, participants will be randomized to the intervention or a control condition.
Read the detailed description
The aim of the current study is to develop and pilot test an anxiety-sensitivity based intervention for co-occurring SUDs and anxiety. In the proposed study, the investigators will develop, refine, and pilot-test an innovative cognitive-behavioral therapy (CBT) for patients who suffer from substance use disorders as well as anxiety. The goal of the research group in the proposed study is to design a protocol that can be testable on a larger sample within an externally-funded, randomized controlled trial. The investigators plan to submit a proposal for this larger grant to the National Institute on Drug Abuse, as outlined in our external funding statement.
Research questions include determining whether a broadly-applicable anxiety sensitivity based intervention can significantly decrease both substance misuse and anxiety. Secondary aims include examining the impact of this intervention on general functioning and depressive/anxious symptoms. In this translational research project, strategies that have been demonstrated to impact the psychological mechanisms thought to underlie both illnesses will be tested in a "real world" clinical setting.
- Being tested
- Psychotherapy (Anxiety Sensitivity Intervention)
- Keywords
- Substance Use Disorders, Anxiety, Anxiety Sensitivity, Brief Intervention, Treatment
- Medical subject headings
- Substance-Related Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy (Anxiety Sensitivity Intervention)Behavioural
3 week, 6-session psychotherapy targeting anxiety sensitivity
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Sensitivity Intervention | Experimental | Group receives the 3-week, 6-session Anxiety Sensitivity Intervention. This is a 6-session psychotherapy occurring twice weekly (60-90 minutes) for three weeks. This psychotherapeutic treatment is focused on reducing anxiety sensitivity and includes many components, but primarily consists of psychoeducation about the relationship between anxiety and substance use disorders, interoceptive exposures, in vivo exposures, and cognitive challenging. Receives: Behavioral: Psychotherapy (Anxiety Sensitivity Intervention) |
| Control Group | No intervention | Receives only treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score on Anxiety Sensitivity Index (ASI; Peterson & Plehn, 1999), from baseline (pre-treatment) to ASI score at 3-months post-treatment.
The ASI is a self-report measure consisting of 16 questions which ask about past-week fear of physical and psychological symptoms of anxiety and fear of potential sequelae of anxiety (e.g., "When I notice my heart is beating rapidly, I worry that might have a heart attack"; or "When my stomach is upset, I worry I might be seriously ill"). Scores over 25 are suggestive of clinically significant anxiety sensitivity (Peterson \& Plehn, 1999).
Measured: Pre, Post, 3-month follow-up
Change in Percent Days Abstinent over the past 30 days on the Timeline Follow-Back (TLFB; Sobell & Sobell, 1996), from Pre-treatment to 3-months post-treatment.
The TLFB is an interview which asks patients to retrospectively report on daily drinking quantity and frequency for the past 30 days. Using a calendar, the interviewer asks the respondent to identify important holidays and other memorable events over the retrospective time window, and then uses these events to help cue the respondent's memory of alcohol /drug use quantity and frequency over this period. Using these prompts and the respondent's knowledge of his/her own drinking/drug use patterns, an report of types of drug used and estimates of quantity of use is obtained for each day in the window. In the current study, the baseline and follow-up TLFBs covered the past 90 days; the post-treatment TLFB covered the past 30 days.
Measured: Pre, Post, 3-Month Follow-Up (measure queries past 30 days only at these time points)
Secondary outcomes (1)
Change in total score on Depression, Anxiety, and Stress Scales (DASS; Brown, Chorpita, Korotitsch, & Barlow, 1997).
The DASS is a 21-item self-report questionnaire which provides total scores for anxiety, depression, and stress subscales. The Depression scale assesses symptoms of dysphoria, hopelessness, devaluation of life, self-deprecation, anhedonia, lack of interest/involvement, and inertia. The Anxiety scale assesses symptoms of autonomic arousal, skeletal musculature effects, situational anxiety, and subjective experience of anxious affect. The Stress scale assesses symptoms of difficulty relaxing, nervous arousal, agitation, irritability/over-reactivity, and impatience. The DASS queries about symptoms in the past week and therefore outcome will be change in total score from pre-treatment to 3 months post-treatment.
Measured: Pre, Post, 3-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other (or Unknown) Substance Use DisordersStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blaise l Worden, Ph.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667015
- Sponsor's protocol ID
- 126253
- Acronym
- SUD/Anx
- Status last verified
- Jan 2016
- First submitted
- 5 Sep 2014
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity
- ClinicalTrials.gov ID
- NCT02667015
- Acronym / sponsor ID
- SUD/Anx / 126253
- Keywords
- Substance Use Disorders, Anxiety, Anxiety Sensitivity, Brief Intervention, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Jan 2016 (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 aim of the current study is to develop and pilot test an anxiety sensitivity-based intervention for co-occurring substance use disorders (SUDs) and anxiety. Research questions include determining whether a broadly-applicable AS-based intervention can significantly decrease both substance misuse and anxiety. Secondary aims include examining the impact of this intervention on general functioning and depressive/anxious symptoms. In phase I, an initial pilot was conducted to examine the feasibility, safety, and patient satisfaction with the protocol, and to estimate potential efficacy of the protocol. In phase II, participants will be randomized to the intervention or a control condition.
Detailed description
The aim of the current study is to develop and pilot test an anxiety-sensitivity based intervention for co-occurring SUDs and anxiety. In the proposed study, the investigators will develop, refine, and pilot-test an innovative cognitive-behavioral therapy (CBT) for patients who suffer from substance use disorders as well as anxiety. The goal of the research group in the proposed study is to design a protocol that can be testable on a larger sample within an externally-funded, randomized controlled trial. The investigators plan to submit a proposal for this larger grant to the National Institute on Drug Abuse, as outlined in our external funding statement.
Research questions include determining whether a broadly-applicable anxiety sensitivity based intervention can significantly decrease both substance misuse and anxiety. Secondary aims include examining the impact of this intervention on general functioning and depressive/anxious symptoms. In this translational research project, strategies that have been demonstrated to impact the psychological mechanisms thought to underlie both illnesses will be tested in a "real world" clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anxiety Sensitivity Intervention | Experimental | Behavioral: Psychotherapy (Anxiety Sensitivity Intervention)Group receives the 3-week, 6-session Anxiety Sensitivity Intervention. This is a 6-session psychotherapy occurring twice weekly (60-90 minutes) for three weeks. This psychotherapeutic treatment is focused on reducing anxiety sensitivity and includes many components, but primarily consists of psychoeducation about the relationship between anxiety and substance use disorders, interoceptive exposures, in vivo exposures, and cognitive challenging. |
| Control Group | No intervention | –Receives only treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- score higher than 25 (established clinical cutoff) on the Anxiety Sensitivity Index (ASI; Peterson \& Plehn, 1999)
- meet the DSM diagnostic criteria for current substance abuse or psychological dependence
Key exclusion criteria (1 listed)
- active psychosis, suicidality, mania, or current physiological withdrawal symptoms that necessitate medical detoxification; no substance use in the past 3 months
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 |
|---|---|---|
| Psychotherapy (Anxiety Sensitivity Intervention)3 week, 6-session psychotherapy targeting anxiety sensitivity | Behavioural | Anxiety Sensitivity Intervention |
Primary outcome
Change in total score on Anxiety Sensitivity Index (ASI; Peterson & Plehn, 1999), from baseline (pre-treatment) to ASI score at 3-months post-treatment.
Time frame: Pre, Post, 3-month follow-up
The ASI is a self-report measure consisting of 16 questions which ask about past-week fear of physical and psychological symptoms of anxiety and fear of potential sequelae of anxiety (e.g., "When I notice my heart is beating rapidly, I worry that might have a heart attack"; or "When my stomach is upset, I worry I might be seriously ill"). Scores over 25 are suggestive of clinically significant anxiety sensitivity (Peterson \& Plehn, 1999).
Change in Percent Days Abstinent over the past 30 days on the Timeline Follow-Back (TLFB; Sobell & Sobell, 1996), from Pre-treatment to 3-months post-treatment.
Time frame: Pre, Post, 3-Month Follow-Up (measure queries past 30 days only at these time points)
The TLFB is an interview which asks patients to retrospectively report on daily drinking quantity and frequency for the past 30 days. Using a calendar, the interviewer asks the respondent to identify important holidays and other memorable events over the retrospective time window, and then uses these events to help cue the respondent's memory of alcohol /drug use quantity and frequency over this period. Using these prompts and the respondent's knowledge of his/her own drinking/drug use patterns, an report of types of drug used and estimates of quantity of use is obtained for each day in the window. In the current study, the baseline and follow-up TLFBs covered the past 90 days; the post-treatment TLFB covered the past 30 days.
1 secondary outcome
Change in total score on Depression, Anxiety, and Stress Scales (DASS; Brown, Chorpita, Korotitsch, & Barlow, 1997).
Time frame: Pre, Post, 3-month Follow-up
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 28 Mar 2016.
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.
Blaise l Worden, Ph.D. principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psychotherapy (Anxiety Sensitivity Intervention) in people with Other (or Unknown) Substance Use Disorders, run by Hartford Hospital 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 2 inclusion and 1 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 28 Mar 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in total score on Anxiety Sensitivity Index (ASI; Peterson & Plehn, 1999), from baseline (pre-treatment) to ASI score at 3-months post-treatment. (time frame: Pre, Post, 3-month follow-up). The study lists 2 primary outcomes in all. 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 28 Mar 2016.