Validating an Autonomous Interactive Internet-Based Delivery of an Empirically Supported Cognitive Behavioral Therapy for Comorbidity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Minnesota

About this trial

This project is designed to determine if a computer-delivered cognitive-behavioral treatment can improve the otherwise poor alcohol use disorder treatment outcomes for individuals with a co-occurring anxiety disorder. In the past, the investigators showed that this treatment does improve outcomes for these individuals when delivered by a therapist. If the present work shows that the computer-delivered version is also effective, it would provide an inexpensive program with virtually unlimited scalability to enable access to the treatment by many more individuals than is currently the case.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

current (past 30 days) Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of panic disorder with or without agoraphobia (PD/Ag), generalized anxiety disorder (GAD) or social anxiety disorder (SAD)

receiving treatment primarily for alcohol (vs. drug) dependence

ability to provide informed consent

a minimum of an eighth grade English reading level

Disqualifiers

cognitive or medical impairments that prohibit study participation as determined by study PI

serious suicide risk determined by study PI

court-ordered treatment. (The exclusion is based on its classification as a "vulnerable" population.)

Self-reported past participation in a Kushner intervention study while in Lodging Plus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy

    Behavioral

    The program provides simplified clinical, learning and neuroscience-based education about the vicious cycle in which negative affect serves to motivate drinking, which, in turn, worsens negative affect. Participants also learn how each of three skills (breathing control, cognitive restructuring, problem solving) was designed to disrupt a specific element of the vicious cycle that includes physiological, psychological and behavioral processes.

  • Progressive Muscle Relaxation Training (PMRT)

    Behavioral

    PMRT is a standard stress management coping skill that entails tensing and releasing specified muscle groups to obtain deep muscle relaxation.

Treatment groups

256 Participants
are divided into 3 treatment groups
Group A: Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidityExperimental treatment 1 intervention
Group B: Control: Progressive Muscle Relaxation Training (PMRT)Active comparator 1 intervention
Group C: Treatment as Usual (TAU)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percent heavy ("binge") days drinking

a ratio expressed as a percent of the days the individual drank 5 (for men) or 4 (for women) or more drinks to the total number of days over the follow-up period in which drinking was possible.

Time frame
eight-months following treatment (four-month assessment is primary)
2

Days to first use

Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.

Time frame
eight-months following treatment (four-month assessment is primary)

Secondary outcomes

1

Any use of alcohol

Any use of alcohol will be binary (yes/no) indicator of whether any alcohol was consumed.

Time frame
eight-months following treatment (four-month assessment is primary)
2

Percent days drinking

a ratio of the days that alcohol was consumed to the total number of possible drinking days.

Time frame
eight-months following treatment (four-month assessment is primary)
3

Days to first binge

Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.

Time frame
eight-months following treatment (four-month assessment is primary)
4

Days to first 3 consecutive days of drinking

Determined for the entirety of the post treatment time for which the investigators have data up to the 8-month assessment.

Time frame
eight-months following treatment (four-month assessment is primary)

Other outcomes

Sponsors and contacts

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