Clinical trial NCT02667015: Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity
Official title: Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Other (or Unknown) Substance Use Disorders
Keywords: Substance Use Disorders
Anxiety
Anxiety Sensitivity
Brief Intervention
Treatment
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* active psychosis, suicidality, mania, or current physiological withdrawal symptoms that necessitate medical detoxification; no substance use in the past 3 months

Primary outcomes:
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.
timeFrame: Pre, Post, 3-month follow-up
measure: 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.
timeFrame: Pre, Post, 3-Month Follow-Up (measure queries past 30 days only at these time points)
Secondary outcomes:
measure: Change in total score on Depression, Anxiety, and Stress Scales (DASS; Brown, Chorpita, Korotitsch, & Barlow, 1997).
timeFrame: Pre, Post, 3-month Follow-up
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Blaise l Worden, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: