Generalized Anxiety Disorder
Conditions
Brief summary
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.
Interventions
BEHAVIORALApplied relaxation and self-control desensitization
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.
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.
BEHAVIORALCognitive-Behavioral Therapy
Includes all of the techniques in the other 2 interventions.
Sponsors
Michelle G. Newman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of GAD
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High End State Function | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Within-group Change Represented as Cohen's d Effect Sizes | 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session | 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. |
Countries
United States
Participant flow
Recruitment details
Principal diagnosis of GAD, no panic disorder, Clinician's Severity Rating (CSR) for GAD of 4 or more, absence of concurrent therapy, no history of having received CBT methods in prior therapy, no medical contributions to the anxiety, no antidepressant medication, and absence of severe MDD, substance abuse, psychosis, and organic brain syndrome.
Participants by arm
| Arm | Count |
|---|---|
| Self-control Desensitization Participants will receive treatment with applied relaxation and self-control desensitization. | 27 |
| Cognitive Therapy Participants will receive treatment with cognitive therapy. | 25 |
| Combined Cognitive Behavioral Therapy Participants will receive treatment with a combination of applied relaxation, self-control desensitization, and cognitive behavioral therapy. | 24 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Self-control Desensitization | Cognitive Therapy | Combined Cognitive Behavioral Therapy |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants | 27 Participants | 25 Participants | 24 Participants |
| Age, Continuous | 37.36 years STANDARD_DEVIATION 11.78 | 38.02 years STANDARD_DEVIATION 10.36 | 38.42 years STANDARD_DEVIATION 11.1 | 35.64 years STANDARD_DEVIATION 13.92 |
| Region of Enrollment United States | 76 participants | 27 participants | 25 participants | 24 participants |
| Sex: Female, Male Female | 52 Participants | 19 Participants | 17 Participants | 16 Participants |
| Sex: Female, Male Male | 24 Participants | 8 Participants | 8 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
Outcome results
Primary
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)
Time frame: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session
Population: People who completed treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Self-control Desensitization | High End State Function | 10-14 days after last therapy session | 56.52 % people meeting high endstate status |
| Self-control Desensitization | High End State Function | 6 month follow-up | 47.62 % people meeting high endstate status |
| Self-control Desensitization | High End State Function | 12 month follow-up | 28.57 % people meeting high endstate status |
| Self-control Desensitization | High End State Function | 24 month follow-up | 47.62 % people meeting high endstate status |
| Cognitive Therapy | High End State Function | 24 month follow-up | 52.38 % people meeting high endstate status |
| Cognitive Therapy | High End State Function | 10-14 days after last therapy session | 43.48 % people meeting high endstate status |
| Cognitive Therapy | High End State Function | 12 month follow-up | 47.62 % people meeting high endstate status |
| Cognitive Therapy | High End State Function | 6 month follow-up | 68.18 % people meeting high endstate status |
| Combined Cognitive Behavioral Therapy | High End State Function | 24 month follow-up | 38.10 % people meeting high endstate status |
| Combined Cognitive Behavioral Therapy | High End State Function | 6 month follow-up | 56.52 % people meeting high endstate status |
| Combined Cognitive Behavioral Therapy | High End State Function | 12 month follow-up | 43.48 % people meeting high endstate status |
| Combined Cognitive Behavioral Therapy | High End State Function | 10-14 days after last therapy session | 56.52 % people meeting high endstate status |
Secondary
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.
Time frame: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session
Population: People who completed treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Self-control Desensitization | Within-group Change Represented as Cohen's d Effect Sizes | 12 month year follow-up | 2.43 Cohen's d within group effect size |
| Self-control Desensitization | Within-group Change Represented as Cohen's d Effect Sizes | 24 month follow-up | 2.34 Cohen's d within group effect size |
| Self-control Desensitization | Within-group Change Represented as Cohen's d Effect Sizes | 6 month follow-up | 2.35 Cohen's d within group effect size |
| Self-control Desensitization | Within-group Change Represented as Cohen's d Effect Sizes | 10-14 days after last therapy session | 2.38 Cohen's d within group effect size |
| Cognitive Therapy | Within-group Change Represented as Cohen's d Effect Sizes | 12 month year follow-up | 2.48 Cohen's d within group effect size |
| Cognitive Therapy | Within-group Change Represented as Cohen's d Effect Sizes | 6 month follow-up | 2.81 Cohen's d within group effect size |
| Cognitive Therapy | Within-group Change Represented as Cohen's d Effect Sizes | 24 month follow-up | 2.67 Cohen's d within group effect size |
| Cognitive Therapy | Within-group Change Represented as Cohen's d Effect Sizes | 10-14 days after last therapy session | 2.95 Cohen's d within group effect size |
| Combined Cognitive Behavioral Therapy | Within-group Change Represented as Cohen's d Effect Sizes | 24 month follow-up | 2.31 Cohen's d within group effect size |
| Combined Cognitive Behavioral Therapy | Within-group Change Represented as Cohen's d Effect Sizes | 10-14 days after last therapy session | 2.8 Cohen's d within group effect size |
| Combined Cognitive Behavioral Therapy | Within-group Change Represented as Cohen's d Effect Sizes | 6 month follow-up | 2.86 Cohen's d within group effect size |
| Combined Cognitive Behavioral Therapy | Within-group Change Represented as Cohen's d Effect Sizes | 12 month year follow-up | 2.45 Cohen's d within group effect size |