Generalized Anxiety Disorder
Conditions
Keywords
anxiety, rural, elderly
Brief summary
The purpose of this study is to determine if cognitive-behavioral therapy (CBT)and supportive therapy delivered by telephone are effective for reducing worry and anxiety in rural older adults with Generalized Anxiety Disorder (GAD).
Detailed description
Older adults in rural locations often face significant barriers to treatment, including stigma, transportation, lack of local appropriately trained service providers, and impaired mobility. The proposed treatment is delivered in a workbook format and by telephone, which maximizes its portability. Treatment will be compared with nondirective supportive therapy, a very credible comparison condition equivalent to the intervention in therapist attention. We propose to randomize 88 adults ≥ 60 years with a diagnosis of GAD to either cognitive behavioral therapy delivered by telephone, or nondirective supportive therapy. The 2 primary treatment outcomes are anxiety symptoms as assessed by the Hamilton Anxiety Rating Scale, and worry symptoms as assessed by the Penn State Worry Questionnaire-Abbreviated. The proposed secondary outcomes are depressive symptoms, sleep, disability, and quality of life. Further, mediators and moderators of the treatment effect will also be examined. Mediators include process variables (therapeutic alliance, adherence, participant satisfaction, and treatment credibility) and new psychotropic medication use; moderators include demographic information (age, education, gender, race, income), psychiatric variables (baseline anxiety severity, baseline depressive disorders, baseline psychotropic medication use), medical comorbidity, and therapist assignment. Maintenance of response will be assessed over 6 months. This research has great public health significance, because it is a low-cost intervention with high potential for widespread dissemination, and it targets an underserved group - community-dwelling rural elders - who currently lack effective treatment interventions tailored to their needs.
Interventions
BEHAVIORALcognitive behavioral therapy
weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
BEHAVIORALnondirective supportive therapy
weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
Sponsors
National Institute of Mental Health (NIMH)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 60 years GAD Reside in rural county Proficient in English
Exclusion criteria
Current psychotherapy Active alcohol or substance abuse with use within last month Dementia or global cognitive impairment Psychotic symptoms Active suicidal ideation with plan and intent Change in psychotropic medications within last 1 month Significant hearing loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13 | baseline to week 13 | self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome. |
| Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13 | baseline to week 13 | interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form (36) Health Survey (SF-36) to Week 13 | week 13 | physical and emotional health related quality of life; The SF-36 is a self-report measure of health-related quality of life (HRQL) consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy, emotional well-being, and general health perceptions. These 8 subscales are also combined into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). All of these scales range from 0 (maximum impairment) to 100 (no impairment). A lower score represents worse outcome. |
| Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks | baseline to week 13 | self report measure of depressive symptoms; scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms Higher scores represent worse outcome. |
| Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13 | baseline to week 13 | Diagnostic and Statistical Manual of Mental Disorders, IV edition (DSM-IV0) symptoms of Generalized Anxiety Disorder; scores range from 0 to 24 with higher scores indicating greater symptoms of GAD; higher score represents worse outcome |
| Insomnia Severity Index (ISI) | week 13 | self-report symptoms of insomnia; scores range from 0 to 28 with higher scores indicating greater symptoms of sleep disturbance; higher score represents worse outcomes |
| Pepper Center Tool for Disability (PCT-D) | week 13 | self report measure of perceived difficulties with mobility and performing basic and advanced activities of daily living; the scale consists of 19 items; scores range from 19 to 114, with higher scores indicating more disability. Higher scores represent worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive-behavioral Therapy Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions | 70 |
| Nondirective Supportive Therapy Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings
psychotherapy: weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions | 71 |
| Total | 141 |
Baseline characteristics
| Characteristic | Cognitive-behavioral Therapy | Nondirective Supportive Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 37 Participants | 66 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 34 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 71 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 64 Participants | 64 Participants | 128 Participants |
| Region of Enrollment United States | 70 participants | 71 participants | 141 participants |
| Sex: Female, Male Female | 58 Participants | 57 Participants | 115 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 70 | 4 / 71 |
| serious Total, serious adverse events | 0 / 70 | 0 / 71 |
Outcome results
Primary
Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13
interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.
Time frame: baseline to week 13
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive-behavioral Therapy | Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13 | -7.04 units on a scale |
| Nondirective Supportive Therapy | Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13 | -5.53 units on a scale |
Primary
Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13
self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.
Time frame: baseline to week 13
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive-behavioral Therapy | Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13 | -9.44 units on a scale |
| Nondirective Supportive Therapy | Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13 | -5.37 units on a scale |
Secondary
Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks
self report measure of depressive symptoms; scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms Higher scores represent worse outcome.
Time frame: baseline to week 13
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive-behavioral Therapy | Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks | -10.77 units on a scale |
| Nondirective Supportive Therapy | Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks | -7.54 units on a scale |
Secondary
Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13
Diagnostic and Statistical Manual of Mental Disorders, IV edition (DSM-IV0) symptoms of Generalized Anxiety Disorder; scores range from 0 to 24 with higher scores indicating greater symptoms of GAD; higher score represents worse outcome
Time frame: baseline to week 13
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive-behavioral Therapy | Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13 | -5.63 units on a scale |
| Nondirective Supportive Therapy | Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13 | -3.27 units on a scale |
Secondary
Insomnia Severity Index (ISI)
self-report symptoms of insomnia; scores range from 0 to 28 with higher scores indicating greater symptoms of sleep disturbance; higher score represents worse outcomes
Time frame: week 13
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive-behavioral Therapy | Insomnia Severity Index (ISI) | 8.70 units on a scale |
| Nondirective Supportive Therapy | Insomnia Severity Index (ISI) | 11.9 units on a scale |
Secondary
Pepper Center Tool for Disability (PCT-D)
self report measure of perceived difficulties with mobility and performing basic and advanced activities of daily living; the scale consists of 19 items; scores range from 19 to 114, with higher scores indicating more disability. Higher scores represent worse outcome.
Time frame: week 13
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive-behavioral Therapy | Pepper Center Tool for Disability (PCT-D) | 1.71 units on a scale |
| Nondirective Supportive Therapy | Pepper Center Tool for Disability (PCT-D) | 1.86 units on a scale |
Secondary
Short Form (36) Health Survey (SF-36) to Week 13
physical and emotional health related quality of life; The SF-36 is a self-report measure of health-related quality of life (HRQL) consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy, emotional well-being, and general health perceptions. These 8 subscales are also combined into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). All of these scales range from 0 (maximum impairment) to 100 (no impairment). A lower score represents worse outcome.
Time frame: week 13
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive-behavioral Therapy | Short Form (36) Health Survey (SF-36) to Week 13 | 60.5 units on a scale |
| Nondirective Supportive Therapy | Short Form (36) Health Survey (SF-36) to Week 13 | 53.5 units on a scale |