# Presentation: 071084

## Treating Late-life Anxiety in Primary Care: Current Status and Future Directions

- Melinda Stanley, Ph.D.
- Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine
- Houston Center for Quality of Care and Utilization Studies, MEDVAMC

**Notes:**
Goals for today:
	Overview our research in late-life anxiety as model of move from efficacy to effectiveness

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## Community Prevalence of Anxiety Disorders in Later Life

- Overall 6-month rates: 3.5 - 10.2%
- Most prevalent: GAD (1.9 – 7.3%)
- More common than depression
- Higher rates among institutionalized elderly
- Prevalence of clinically significant anxiety symptoms even higher (20%)

## Prevalence of Late-Life Anxiety in Primary Care

|  | Anxiety Disorders | GAD | Anxiety Symptoms |
| --- | --- | --- | --- |
| General medical samples | 
11 -15%
 | 
3-11% | 
20% |
| Patients with chronic illness | 
20% - 38%
 | 
Up to 19% | 
16% - 40% |

## Impact of Anxiety in Later Life

- Physical activity  & disability
- Functional status
- Over and above physical health status
- Self-perceptions of health

- Quality of life and satisfaction
- Loneliness
- Increased mortality
- Service utilization and health care costs

## 1997 NAMCS: Recognition of Anxiety & Affective Disorders 

- Stanley et al. (2001), _J Clin Geropsych_

## Treatment of Late-life Anxiety

- Most patients seen in primary care
- Many remain unrecognized and without treatment
- Medication most common modality
- Benzodiazepines:
- 10-20% (up to 43%)
- Efficacy data
- Risk-benefit profile limits utility
- Antidepressants
- Efficacious, but still drawbacks

## Cognitive Behavior Therapy (CBT) for Late-Life Anxiety

- Acceptance and preference data
- Approach is
- Time-limited
- Directive
- Collaborative
- Efficacy data
- Treatment of choice for anxiety in younger adults
- Older adults with depression

## Goals of our Late-Life Anxiety Research Program:

- Evaluate efficacy of CBT for late-life GAD
- Two academic clinical trials (1996, 2003)
- Modify and test treatments in primary care
- Pilot work
- Ongoing trial
- Next efforts
- Move from efficacy to effectiveness
- Increasing emphasis on translational value and sustainability in primary care

## Efficacy: Academic Clinical trials of CBT for Late-life GAD

- CBT includes
- Education/awareness
- Relaxation
- Cognitive Therapy
- Exposure
- 12-15 weeks
- Control groups:
- WL (d = .71)
- Supportive treatment (d = .20 - .29)

- Response rates
- Group treatment:
- Post: 28-45%
- FU: 50-63%
- Individual treatment:
- Post: 40-75%
- FU: 57-75%

- Stanley MA, et al. *J Consult Clin Psychol.* 2003;  Stanley MA, et al. *Behav Ther.* 1996; Wetherell JL, et al. *J Consult Clin Psychol.* 2003; Mohlman J, et al. *Am J Geriatr Psychiatry*. 2003; Mohlman et al., *Behav Res Ther 2005.*

**Notes:**
Potential predictors of outcome:

Homework adherence
Baseline GAD severity
Coexistent disorder(s)
Executive functioning

## Limitations of the Data

- Homogeneous and non-representative samples
- Young old (mean age mid-60’s)
- Medically healthy
- Cognitively intact
- Caucasian (80% – 90%)
- Well educated (mean 14 years)

- Treatment not designed for older adults
- Outcomes not optimal
- All data from academic clinical settings

## First steps toward effectiveness

- _Develop collaborative relationship with primary care_
- Kelsey-Seybold Clinic
- Baylor Family Medicine
- MEDVAMC
- _Modify intervention model to_:
- Improve outcomes
- Identify and meet the needs of more representative patient groups
- _Move toward collaborative care models_
- Younger adult anxiety (Rollman, Craske)
- Older adult depression (Unutzer, Bartels)
- Effect sizes = .23 to .57

## New Version of CBT for Late-Life GAD in Primary Care

- 8 – 10 sessions
- Increased attention to learning & memory
- More flexible treatment:
- Individual care
- Vary # and timing of meetings
- Home visits
- Differential emphasis of coping skills

- Wider range of treatment components:
- Education/awareness
- Relaxation
- Changing thoughts
- Exposure
- Problem-solving
- Sleep management skills

## Pilot Work (Stanley et al., 2003, Am J Geriatr Psychiatry)

- Open clinical trial, _n_ = 8
- Test feasibility
- Modify treatment based on therapist and patient input
- Small clinical trial, _n_ = 12
- CBT vs. usual care (UC)
- Benefits in worry & GAD severity, depression

## Ongoing trial: STOP Worry Project(NIMH renewal)

- Goal: n = 150 older primary care patients with GAD
- Settings
- Kelsey-Seybold Clinic
- Baylor Family Medicine
- Inclusion criteria
- GAD
- MMSE _>_ 24
- English-speaking

## STOP Worry Project Team

_*Investigators*_
- Mark Kunik, M.D.
- Diane Novy, Ph.D.
- Nancy Wilson, M.A., L.M.S.W.
- Howard Rhoades, Ph.D.
- Anthony Greisinger, Ph.D.

_*Current Study Staff*_
- Paula Wagener, B.A.
- Cynthia Kraus, Ph.D.
- Christopher Griffith, B.A.
- Jessica Calleo, M.A.
- Brandon Weiss

## Design Elements	

- Efficacy
- Random assignment
- Comprehensive outcome battery
- Expert clinicians and independent evaluators
- Treatment integrity raters
- “Clean” treatment

- Effectiveness
- Recruit & treat in primary care
- Less restrictive inclusion criteria
- Telephone-based assessments
- Control condition = UC
- More flexible treatment

- Stop Worry Design

-     MMSE

-    Consent
-        &
-     Screen

- Exclude, Refer

- Exclude, Refer

-        3-Month
-     Assessment

-        Follow-Up            Assessments
-     (1 year)

-  UC

- CBT

-       SCID
-          &
-    Baseline
- Assessment

## STOP Worry Design (cont’d)

- CBT
- Conducted in the primary care clinic (or patient’s home)
- Master’s level clinicians
- Treatment integrity ratings - excellent
- UC
- Biweekly telephone contact
- Assessments (3 mo. & 1-year FU)
- Telephone-based
- Independent evaluators

## Outcome Measures

- Worry
- GAD Severity (GADSS)
- Penn State Worry Questionnaire (PSWQ)
- Anxiety
- Beck Anxiety Inventory (BAI)
- SIGH-A (Hamilton)

- Depression
- Beck Depression Inventory (BDI)
- Quality of Life
- Quality of Life Inventory (QOLI)
- SF – 12
- Health Service Use

## Recruitment Strategies

- Timeline: 3/04 to 8/06
- 2 2-month interruptions
- Total 26 months
- Self-referral
- Brochures: Waiting rooms, newsletters, Information Center
- Letters to patients
- Provider referral
- Presentations, meetings
- E-mail reminders

## Recruitment Summary

- 968 patients referred
- 381 signed consent, 313 assessed
- 165 excluded
- No GAD, cognitive impairment
- 11 non-study clinical training cases
- 148 included (99% of target!)
- Approx. 6 per month
- 95% self-referred

## Sample Characteristics (n = 148)

- Demographics
- 78% women
- Mean age = 67 years (SD = 5.8)
- Mean education = 16 years (SD = 3.0)
- 17% African American; 9% Hispanic
- 50% using psychotropic medication
- Coexistent psychiatric diagnosis
- 69% at least 1
- 45% Depression (MDD, Dysthymia, NOS)
- 26% Specific Phobia
- 14% Social Phobia

## Treatment Progress (1/07)

|  | CBT | UC |
| --- | --- | --- |
| Randomized | 70 | 64 |
| ITT | 61 | 57 |
| Completed | 42 | 37 |

- Overall attrition = 27%
- [9% before randomization; 12% before post-treatment;
- 6% during follow-up]
- Higher attrition in UC (26%) vs. CBT (13%)

## ITT Analysis: PSWQ change scores

- 3-month d = .64 (.001); 6-month d = .73 (.001)

## ITT Analysis: SIGH-A change scores

- 3-month d = .28 (ns); 6-month d = .46 (.02)

## ITT Analysis: GADSS change scores

- 3-month d = .35 (.06); 6-month d = .35 (.06)

## Summary & Limitations

- CBT is moderately effective relative to UC
- Effect sizes equivalent to other collaborative care studies (.28 - .73 vs. .23 - .57)
- Increasing effects over time
- Low attrition in CBT (13%)
- Translational value limited
- Homogeneous, non-representative sample
- Limited generalizability of treatment to real-world care (expert providers, long sessions, no attention to patient preference)

## Future Directions: Peaceful Living Project

- _Increase emphasis on effectiveness and collaborative care models_
- Examine effectiveness of CBT delivered by non-expert providers
- Enhance communication and collaboration with primary care via use of EMR
- Modify CBT to increase flexibility and enhance translational value/sustainability
- Implement intervention in more diverse medical setting (BCM, MEDVAMC)

## Peaceful Living Team

- Academic investigators
- Mark Kunik, M.D.
- Nancy Wilson, M.A., L.M.S.W.
- Jeff Cully, Ph.D.
- Louise Quijano, Ph.D., L.C.S.W.
- Michael Kallen, Ph.D., M.P.H.

- Primary care investigators
- Michael Crouch, M.D. (BCM)
- Victor Narcisse, M.D. (BCM)
- Stinson Tillerson, M.D. (MEDVAMC)

## Peaceful Living: CBT Modifications

- Modular treatment
- Integrate telephone-based service delivery
- Incorporate patient preference
- Briefer sessions and simplified procedures
- BA module to target coexistent depression
- Extended duration of treatment, with intensive telephone booster phase

## Treatment Components

- Core modules
- Education & awareness
- Motivational exercise
- Breathing
- Coping self-statements

- Elective modules
- Relaxation
- Cognitive therapy
- Sleep skills
- Problem-solving
- Behavioral activation
- Exposure

## Treatment Process

- _First 3 months_
- Sessions 1-3: Core modules
- Sessions 6-9: Elective modules
- Patient preference: Content, mode
- Session 10: Review
- 26% telephone sessions
- _Second 3 months_
- Intensive telephone follow-up

## Peaceful Living: Open Trial 

- _Study sites_
- BCM Family Medicine
- MEDVAMC
- _New recruitment procedures_
- Identify potential patients through EMR
- PCP sends letter of invitation
- _Recruitment success_
- More physician-referred patients (44% vs. 5% in STOP Worry)
- Greater diversity (53% women; 67% Caucasian)
- Higher baseline severity (GADSS, SIGH-A)

## Peaceful Living: Open Trial

- _Treatment process_
- Group assignment:
- Anxiety Clinic Specialists (MA-level or above)
- Counselor (BA-level or below)
- Adherence/competence equivalent in 2 groups
- _Treatment progress_
- 16 patients included
- CBT-ACS (_n_ = 9); CBT-Counselor (_n_ = 7)
- Completers: 3-months (_n_ = 10); 6-months (_n_ = 8)
- Within-subject d = .43 to 1.39

## SIGH-A: STOP Worry vs. PLWithin CBT effect sizes

## GADSS: STOP Worry vs. PLWithin CBT effect sizes

## PSWQ: STOP Worry vs. PLWithin CBT effect sizes

## Peaceful Living: Summary

- Effects generally are comparable to or greater than STOP Worry
- Exception: PSWQ at 6-months
- Patients are more diverse and have more severe symptoms
- Intervention model is more sustainable
- NIMH should give us 5 more years!

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