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Completed

NCT Number: NCT01259596

Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)

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).

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

Other names: CBT

nondirective supportive therapy

Behavioral

weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions

Other names: NST

Primary outcomes

  1. Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13

    Time frame: 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.

  2. Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13

    Time frame: 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 outcomes

  1. Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks

    Time frame: 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.

  2. Pepper Center Tool for Disability (PCT-D)

    Time frame: 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.

  3. Short Form (36) Health Survey (SF-36) to Week 13

    Time frame: 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.

  4. Insomnia Severity Index (ISI)

    Time frame: 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

  5. Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Randomized Controlled Trial (RCT)of Cognitive Behavioral Therapy-Telephone (CBT-T) for Late-Life Generalized Anxiety Disorder (GAD)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 14, 2010
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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