Worry Exposure for Generalized Anxiety Disorder

NCT02382224 | Withdrawn DMC

• 1 other identifier: 2015-02-0025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the efficacy of a worry exposure intervention, a form of cognitive behavioral therapy (CBT), in comparison to a waitlist condition for the treatment of Generalized Anxiety Disorder. There will be a total of 60 subjects enrolled at the University of Texas at Austin. Patients will be randomized (like a flip of a coin) to either 12-sessions of WE therapy or a 12-week waitlist before being offered entry into therapy.

Conditions

Generalized Anxiety Disorder

Keywords

generalized anxiety disorder; anxiety; worry exposure; treatment

Outcome Measures

Primary Outcomes (1)

• Change in Penn State Worry Questionnaire (PSWQ).

  The PSWQ will be administered 6 separate occasions. The investigators will measure the change in PSWQ scores from pre-treatment to weeks 3, 6, 9, 12, and 38. The PSWQ is a 16-item inventory designed to capture the generality, excessiveness, and uncontrollability of pathological worry. It has been shown to have good internal consistency with samples consisting of older adults with GAD, community subjects, and undergraduates. It has also demonstrated good test-retest reliability over 8-10 weeks.

  Up to 6 months

Secondary Outcomes (1)

• Beck Anxiety Inventory (BAI).

  Up to 6 months

Study Arms (2)

Worry Exposure for GAD

EXPERIMENTAL

WE is an optimized protocol that incorporates elements of CBT, without the addition of other miscellaneous methods of treatment. A therapist manual will be used and followed at all times to ensure standardized delivery of the program. Interventions that uniquely focus on addressing GAD symptoms will include confronting physical or imagined stimuli through in vivo exposure and WE respectively. Avoidance behaviors will be monitored and reduced systematically, an outcomes will be assessed at baseline, during the 12-week intervention, and at 6-month follow-up.

Behavioral: Worry Exposure for GAD

12-week Waitlist

PLACEBO COMPARATOR

Those who are randomized to the waitlist condition will wait for 12 weeks before beginning the worry exposure.

Behavioral: 12-week Waitlist

Interventions

Worry Exposure for GAD BEHAVIORAL

WE is an optimized protocol that incorporates elements of CBT, without the addition of other miscellaneous methods of treatment. A therapist manual will be used and followed at all times to ensure standardized delivery of the program. Interventions that uniquely focus on addressing GAD symptoms will include confronting physical or imagined stimuli through in vivo exposure and WE respectively. Avoidance behaviors will be monitored and reduced systematically, an outcomes will be assessed at baseline, during the 12-week intervention, and at 6-month follow-up.

Worry Exposure for GAD

12-week Waitlist BEHAVIORAL

Those who are randomized to the waitlist condition will wait for 12 weeks before beginning the worry exposure.

12-week Waitlist

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be between 18 and 65 years of age
• principal diagnosis of Generalized Anxiety Disorder
• be willing to and capable of providing informed consent, attending all study visits, and complying with the protocol

You may not qualify if:

• current diagnosis of a psychotic, developmental, or bipolar disorder
• significant suicide risk as determined by structured interview
• psychoactive substance dependence within the past 3 months
• Inability to communicate in English
• limited mental competency and the inability to give informed, voluntary, written consent to participate
• psychotropic medications are acceptable only if they are stabilized for at least 3 weeks prior to the baseline visit

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

glutamate decarboxylase 1; Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Mark B Powers, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: February 7, 2015
• First Posted: March 6, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

US (1)