Development of an Anxiety Sensitivity-Based Intervention for Substance Use and Anxiety Comorbidity

NCT ID: NCT02667015

Last Updated: 2016-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Other (or Unknown) Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Psychotherapy (Anxiety Sensitivity Intervention)

Intervention Type BEHAVIORAL

3 week, 6-session psychotherapy targeting anxiety sensitivity

Control Group

Receives only treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychotherapy (Anxiety Sensitivity Intervention)

3 week, 6-session psychotherapy targeting anxiety sensitivity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blaise l Worden, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

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Institute of Living/Hartford Hospital

Hartford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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126253

Identifier Type: -

Identifier Source: org_study_id

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