Generalized Anxiety DisorderNCT02382224
Worry Exposure for Generalized Anxiety Disorder
A study testing Worry Exposure for GAD and 12-week Waitlist in people with Generalized Anxiety Disorder, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Worry Exposure for GAD and 12-week Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2018
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This application proposes a randomized controlled trial, which aims to examine the efficacy of a worry exposure (WE) intervention for the treatment of generalized anxiety disorder (GAD). This protocol is based on a GAD treatment manual first tested in Germany. It has been translated into English, but this version has not yet been tested.
A growing body of research calls for the development of novel interventions for individuals with GAD. GAD is a chronic and debilitating condition with high rates of recurrence, with a lifetime prevalence of 5.7%. Although efficacious psychological interventions exist, many are either not receiving these interventions or remain highly symptomatic following the termination of these interventions. More specifically, cognitive behavioral therapy (CBT) is the only empirically supported treatment for GAD. However, many patients relapse or continue to experience significant symptoms after treatment. Up to 57% of patients do not meet criteria for high endstate functioning after CBT. Together, these findings call for the development of better interventions that are efficacious and easy to disseminate.
The core symptom of GAD is persistent and uncontrollable worry, which allows the individual a way to cognitively avoid perceived threats and emotionally dangerous situations. One study examined the efficacy of WE alone, applied relaxation (AR) alone, and a WL control group, finding that WE was an effective treatment for GAD, concluding that WE should be developed further. Given other areas of avoidance for patients with GAD, the authors recommended adding in vivo exposure in future trials.
The present application proposes to test WE with the addition of in vivo exposure in the United States as an effective treatment for GAD. The present study involves the randomization of 60 adults with GAD to either (1) 12-sessions of WE therapy or (2) a 12-week waitlist (WL), before entering into therapy. The authors hypothesize that participants in the WE intervention will evidence greater reductions in anxiety symptom severity and measures of quality of life relative to individuals randomized to the WL.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Worry Exposure for GAD, 12-week Waitlist
- Keywords
- generalized anxiety disorder, anxiety, worry exposure, treatment
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Worry Exposure for GADBehavioural
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.
12-week WaitlistBehavioural
Those who are randomized to the waitlist condition will wait for 12 weeks before beginning the worry exposure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: 12-week Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (1)
Beck Anxiety Inventory (BAI).
The BAI will be administered 6 separate occasions. The investigators will measure the change in BAI scores from pre-treatment to weeks 3, 6, 9, 12, and 38. The BAI is a commonly used 21-item, self-report inventory designed to measure severity of anxiety symptoms.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: insufficient study staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark B. Powers, University of Texas at Austin
- Investigators
- Mark B Powers, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382224
- Sponsor's protocol ID
- 2015-02-0025
- Status last verified
- Jul 2018
- First submitted
- 7 Feb 2015
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worry Exposure for Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02382224
- Acronym / sponsor ID
- 2015-02-0025
- Conditions
- Generalized Anxiety Disorder
- Keywords
- generalized anxiety disorder, anxiety, worry exposure, treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient study staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 6 Mar 2015 (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 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.
Detailed description
This application proposes a randomized controlled trial, which aims to examine the efficacy of a worry exposure (WE) intervention for the treatment of generalized anxiety disorder (GAD). This protocol is based on a GAD treatment manual first tested in Germany. It has been translated into English, but this version has not yet been tested.
A growing body of research calls for the development of novel interventions for individuals with GAD. GAD is a chronic and debilitating condition with high rates of recurrence, with a lifetime prevalence of 5.7%. Although efficacious psychological interventions exist, many are either not receiving these interventions or remain highly symptomatic following the termination of these interventions. More specifically, cognitive behavioral therapy (CBT) is the only empirically supported treatment for GAD. However, many patients relapse or continue to experience significant symptoms after treatment. Up to 57% of patients do not meet criteria for high endstate functioning after CBT. Together, these findings call for the development of better interventions that are efficacious and easy to disseminate.
The core symptom of GAD is persistent and uncontrollable worry, which allows the individual a way to cognitively avoid perceived threats and emotionally dangerous situations. One study examined the efficacy of WE alone, applied relaxation (AR) alone, and a WL control group, finding that WE was an effective treatment for GAD, concluding that WE should be developed further. Given other areas of avoidance for patients with GAD, the authors recommended adding in vivo exposure in future trials.
The present application proposes to test WE with the addition of in vivo exposure in the United States as an effective treatment for GAD. The present study involves the randomization of 60 adults with GAD to either (1) 12-sessions of WE therapy or (2) a 12-week waitlist (WL), before entering into therapy. The authors hypothesize that participants in the WE intervention will evidence greater reductions in anxiety symptom severity and measures of quality of life relative to individuals randomized to the WL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Worry Exposure for GAD | Experimental | Behavioral: Worry Exposure for GADWE 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. |
| 12-week Waitlist | Placebo comparator | Behavioral: 12-week WaitlistThose who are randomized to the waitlist condition will wait for 12 weeks before beginning the worry exposure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Worry Exposure for GADWE 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. | Behavioural | Worry Exposure for GAD |
| 12-week WaitlistThose who are randomized to the waitlist condition will wait for 12 weeks before beginning the worry exposure. | Behavioural | 12-week Waitlist |
Primary outcome
Change in Penn State Worry Questionnaire (PSWQ).
Time frame: Up to 6 months
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.
1 secondary outcome
Beck Anxiety Inventory (BAI).
Time frame: Up to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
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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.
Mark B Powers, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Worry Exposure for GAD and 12-week Waitlist in people with Generalized Anxiety Disorder, run by University of Texas at Austin 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 24 Jul 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Penn State Worry Questionnaire (PSWQ). (time frame: Up to 6 months). 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 24 Jul 2018; AzTrials last refreshed its copy on 30 Oct 2026.