Generalized Anxiety DisorderNCT00635999
A Comparison Between Cognitive, Behavioral, and Cognitive-Behavioral Therapy for Generalized Anxiety Disorder
A study testing Cognitive therapy (CT) and Cognitive-Behavioral Therapy in people with Generalized Anxiety Disorder, run by Michelle G. Newman at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cognitive therapy (CT) and Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1991to Oct 1998
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of GAD
Who cannot join
- Diagnosis of any of the following: panic disorder, subclinical GAD, severe depression, psychosis, or organic brain syndrome
- Currently receiving therapy for GAD or has previously received CBT
- Medical contributions to anxiety
- Currently taking antidepressant medication
- Current substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Desensitization and Cognitive Therapy in General Anxiety
This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder.
Read the detailed description
Generalized anxiety disorder (GAD) is a common psychiatric disorder that affects nearly 6.8 million adults in the United States. GAD is characterized by persistent feelings of worry and anxiety that remain even when there is little reason for concern. The excessive worry that people with GAD experience can be so extreme that carrying out activities of daily life becomes difficult. GAD is often accompanied by physical symptoms as well, including muscle aches, nausea, sweating, exhaustion, irritability, frequent urination, and shaking. People with GAD are also at a higher risk for other disorders, including depression and substance abuse, making early treatment of GAD important. Forms of psychotherapy that concentrate on stress management, relaxation techniques, and control of thoughts about anxiety-provoking situations may be effective treatments for people with GAD. This study will evaluate the effectiveness of three adaptive coping treatments, relaxation and self-control desensitization, cognitive behavioral therapy (CBT), and a combination of the two, in lessening anxiety in adults with GAD.
Participation in this study will last about 28 months. All participants will first complete three assessment sessions that will include an interview about anxiety symptoms and medical history, self-report questionnaires, and a physiological evaluation. After the first interview, participants will be asked to rate their level of anxiety four times a day in a diary. They will continue with these daily diary entries through the completion of treatment. Once participants complete the first 2 weeks' worth of daily ratings, participants will be assigned randomly to receive treatment with relaxation and self-control desensitization, CBT, or a combination of the two treatments. All participants will receive 14 weekly treatment sessions lasting between 1.5 and 2 hours each. During CBT sessions, participants will learn to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Between sessions, all participants will complete homework assignments that will involve practicing the approaches learned in sessions and continuing the daily diaries.
Upon completion of treatment, participants will repeat the initial assessments. Follow-up visits will occur at Months 6, 12, and 24 after treatment completion and will include repeat interview and self-report sessions and completion of 1 week's worth of daily diary entries before each visit.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Applied relaxation and self-control desensitization, Cognitive therapy (CT), Cognitive-Behavioral Therapy
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied relaxation and self-control desensitizationBehavioural
Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Treatment will include 14 weekly sessions.
Cognitive therapy (CT)Other
CT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CT will include 14 weekly sessions.
Cognitive-Behavioral TherapyBehavioural
Includes all of the techniques in the other 2 interventions.
| Study group | Role | What they receive |
|---|---|---|
| Purely Behavioral therapy | Experimental | Participants will receive treatment with progressive and applied relaxation and self-control desensitization. Receives: Behavioral: Applied relaxation and self-control desensitization |
| Cognitive-Behavioral Therapy | Experimental | Participants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization Receives: Behavioral: Cognitive-Behavioral Therapy |
| Cognitive Therapy (CT) | Experimental | Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring. Receives: Other: Cognitive therapy (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
High End State Function
Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire)
Measured: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session
Secondary outcomes (1)
Within-group Change Represented as Cohen's d Effect Sizes
Cohen's d within-group effect sizes comparing pre-therapy assessment to assessment at 10-14 days after last therapy session, at 6-month follow-up, at 12-month follow-up, and at 24-month follow-up. Findings reported in table are Cohen's d effect sizes averaged over Hamilton Anxiety Scale (scores ranging from 0-56, higher scores mean more anxiety), the Assessor Severity Scale (scores ranging from 0-8, higher scores mean more severity), and the State-Trait Anxiety Inventory-Trait version (scores ranging from 20-80, higher scores mean more state anxiety). The within-group effective sizes are the posttherapy [or follow-up] mean minus pretherapy mean divided by the pretherapy standard deviation.
Measured: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startOct 1991
- Primary completionOct 1998
- Study completionOct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle G. Newman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michelle G. Newman, Penn State University
- Investigators
- Michelle G. Newman, PhD, Study director, Penn State UniversityThomas D. Borkovec, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635999
- Sponsor's protocol ID
- R01MH039172-01
- Status last verified
- Jan 2018
- First submitted
- 12 Mar 2008
- Last updated
- 25 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Summary data has been shared.
Publications
Roemer L, Molina S, Borkovec TD. An investigation of worry content among generally anxious individuals. J Nerv Ment Dis. 1997 May;185(5):314-9. doi: 10.1097/00005053-199705000-00005.
PubMed 9171808Roemer L, Molina S, Litz BT, Borkovec TD. Preliminary investigation of the role of previous exposure to potentially traumatizing events in generalized anxiety disorder. Depress Anxiety. 1996-1997;4(3):134-8. doi: 10.1002/(SICI)1520-6394(1996)4:33.0.CO;2-G.
PubMed 9166642Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PubMed 11132119Schut AJ, Castonguay LG, Borkovec TD. Compulsive checking behaviors in generalized anxiety disorder. J Clin Psychol. 2001 Jun;57(6):705-15. doi: 10.1002/jclp.1043.
PubMed 11344459Stöber, J., & Borkovec, T. D. (2002). Reduced concreteness of worry in generalized anxiety disorder: Findings from a therapy study. Cognitive Therapy and Research, 26, 89-96.
Behar E, Alcaine O, Zuellig AR, Borkovec TD. Screening for generalized anxiety disorder using the Penn State Worry Questionnaire: a receiver operating characteristic analysis. J Behav Ther Exp Psychiatry. 2003 Mar;34(1):25-43. doi: 10.1016/s0005-7916(03)00004-1.
PubMed 12763391McLaughlin KA, Behar E, Borkovec TD. Family history of psychological problems in generalized anxiety disorder. J Clin Psychol. 2008 Jul;64(7):905-18. doi: 10.1002/jclp.20497.
PubMed 18509873Cassidy J, Lichtenstein-Phelps J, Sibrava NJ, Thomas CL Jr, Borkovec TD. Generalized anxiety disorder: connections with self-reported attachment. Behav Ther. 2009 Mar;40(1):23-38. doi: 10.1016/j.beth.2007.12.004. Epub 2008 Jun 24.
PubMed 19187814Newman MG, Przeworski A, Fisher AJ, Borkovec TD. Diagnostic comorbidity in adults with generalized anxiety disorder: impact of comorbidity on psychotherapy outcome and impact of psychotherapy on comorbid diagnoses. Behav Ther. 2010 Mar;41(1):59-72. doi: 10.1016/j.beth.2008.12.005. Epub 2009 Jun 8.
PubMed 20171328Newman MG, Fisher AJ. Expectancy/Credibility Change as a Mediator of Cognitive Behavioral Therapy for Generalized Anxiety Disorder: Mechanism of Action or Proxy for Symptom Change? Int J Cogn Ther. 2010 Sep;3:245-261. doi: 10.1521/ijct.2010.3.3.245.
PubMed 21132075Borkovec TD, Newman MG, Pincus AL, Lytle R. A component analysis of cognitive-behavioral therapy for generalized anxiety disorder and the role of interpersonal problems. J Consult Clin Psychol. 2002 Apr;70(2):288-98.
PubMed 11952187
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desensitization and Cognitive Therapy in General Anxiety
- ClinicalTrials.gov ID
- NCT00635999
- Acronym / sponsor ID
- R01MH039172-01
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Michelle G. NewmanUniversity, hospital or other
- Study start
- Oct 1991
- Primary completion
- Oct 1998 (actual)
- Study completion
- Oct 1998 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 25 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder.
Detailed description
Generalized anxiety disorder (GAD) is a common psychiatric disorder that affects nearly 6.8 million adults in the United States. GAD is characterized by persistent feelings of worry and anxiety that remain even when there is little reason for concern. The excessive worry that people with GAD experience can be so extreme that carrying out activities of daily life becomes difficult. GAD is often accompanied by physical symptoms as well, including muscle aches, nausea, sweating, exhaustion, irritability, frequent urination, and shaking. People with GAD are also at a higher risk for other disorders, including depression and substance abuse, making early treatment of GAD important. Forms of psychotherapy that concentrate on stress management, relaxation techniques, and control of thoughts about anxiety-provoking situations may be effective treatments for people with GAD. This study will evaluate the effectiveness of three adaptive coping treatments, relaxation and self-control desensitization, cognitive behavioral therapy (CBT), and a combination of the two, in lessening anxiety in adults with GAD.
Participation in this study will last about 28 months. All participants will first complete three assessment sessions that will include an interview about anxiety symptoms and medical history, self-report questionnaires, and a physiological evaluation. After the first interview, participants will be asked to rate their level of anxiety four times a day in a diary. They will continue with these daily diary entries through the completion of treatment. Once participants complete the first 2 weeks' worth of daily ratings, participants will be assigned randomly to receive treatment with relaxation and self-control desensitization, CBT, or a combination of the two treatments. All participants will receive 14 weekly treatment sessions lasting between 1.5 and 2 hours each. During CBT sessions, participants will learn to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Between sessions, all participants will complete homework assignments that will involve practicing the approaches learned in sessions and continuing the daily diaries.
Upon completion of treatment, participants will repeat the initial assessments. Follow-up visits will occur at Months 6, 12, and 24 after treatment completion and will include repeat interview and self-report sessions and completion of 1 week's worth of daily diary entries before each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Purely Behavioral therapy | Experimental | Behavioral: Applied relaxation and self-control desensitizationParticipants will receive treatment with progressive and applied relaxation and self-control desensitization. |
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive-Behavioral TherapyParticipants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization |
| Cognitive Therapy (CT) | Experimental | Other: Cognitive therapy (CT)Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary diagnosis of GAD
Key exclusion criteria (5 listed)
- Diagnosis of any of the following: panic disorder, subclinical GAD, severe depression, psychosis, or organic brain syndrome
- Currently receiving therapy for GAD or has previously received CBT
- Medical contributions to anxiety
- Currently taking antidepressant medication
- Current substance abuse
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 |
|---|---|---|
| Applied relaxation and self-control desensitizationApplied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Treatment will include 14 weekly sessions. | Behavioural | Purely Behavioral therapy |
| Cognitive therapy (CT)CT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CT will include 14 weekly sessions. | Other | Cognitive Therapy (CT) |
| Cognitive-Behavioral TherapyIncludes all of the techniques in the other 2 interventions. | Behavioural | Cognitive-Behavioral Therapy |
Primary outcome
High End State Function
Time frame: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session
Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire)
1 secondary outcome
Within-group Change Represented as Cohen's d Effect Sizes
Time frame: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9171808Roemer L, Molina S, Borkovec TD. An investigation of worry content among generally anxious individuals. J Nerv Ment Dis. 1997 May;185(5):314-9. doi: 10.1097/00005053-199705000-00005.
- Background: PubMed 9166642Roemer L, Molina S, Litz BT, Borkovec TD. Preliminary investigation of the role of previous exposure to potentially traumatizing events in generalized anxiety disorder. Depress Anxiety. 1996-1997;4(3):134-8. doi: 10.1002/(SICI)1520-6394(1996)4:33.0.CO;2-G.
- Background: PubMed 11132119Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
- Background: PubMed 11344459Schut AJ, Castonguay LG, Borkovec TD. Compulsive checking behaviors in generalized anxiety disorder. J Clin Psychol. 2001 Jun;57(6):705-15. doi: 10.1002/jclp.1043.
- BackgroundStöber, J., & Borkovec, T. D. (2002). Reduced concreteness of worry in generalized anxiety disorder: Findings from a therapy study. Cognitive Therapy and Research, 26, 89-96.
- Background: PubMed 12763391Behar E, Alcaine O, Zuellig AR, Borkovec TD. Screening for generalized anxiety disorder using the Penn State Worry Questionnaire: a receiver operating characteristic analysis. J Behav Ther Exp Psychiatry. 2003 Mar;34(1):25-43. doi: 10.1016/s0005-7916(03)00004-1.
- Background: PubMed 18509873McLaughlin KA, Behar E, Borkovec TD. Family history of psychological problems in generalized anxiety disorder. J Clin Psychol. 2008 Jul;64(7):905-18. doi: 10.1002/jclp.20497.
- Background: PubMed 19187814Cassidy J, Lichtenstein-Phelps J, Sibrava NJ, Thomas CL Jr, Borkovec TD. Generalized anxiety disorder: connections with self-reported attachment. Behav Ther. 2009 Mar;40(1):23-38. doi: 10.1016/j.beth.2007.12.004. Epub 2008 Jun 24.
- Background: PubMed 20171328Newman MG, Przeworski A, Fisher AJ, Borkovec TD. Diagnostic comorbidity in adults with generalized anxiety disorder: impact of comorbidity on psychotherapy outcome and impact of psychotherapy on comorbid diagnoses. Behav Ther. 2010 Mar;41(1):59-72. doi: 10.1016/j.beth.2008.12.005. Epub 2009 Jun 8.
- Background: PubMed 21132075Newman MG, Fisher AJ. Expectancy/Credibility Change as a Mediator of Cognitive Behavioral Therapy for Generalized Anxiety Disorder: Mechanism of Action or Proxy for Symptom Change? Int J Cogn Ther. 2010 Sep;3:245-261. doi: 10.1521/ijct.2010.3.3.245.
- Results publication: PubMed 11952187Borkovec TD, Newman MG, Pincus AL, Lytle R. A component analysis of cognitive-behavioral therapy for generalized anxiety disorder and the role of interpersonal problems. J Consult Clin Psychol. 2002 Apr;70(2):288-98.
- Individual participant dataSharing planned: No. Summary data has been shared.
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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.
Michelle G. Newman, PhD study director
Penn State University
Thomas D. Borkovec, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive therapy (CT) and Cognitive-Behavioral Therapy in people with Generalized Anxiety Disorder, run by Michelle G. Newman 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jan 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. 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?
Yes. Results are posted in the registry (first posted 25 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
High End State Function (time frame: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635999, which also lists 11 linked publications.
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 25 Jan 2018.