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

NCT01259596 | Completed Results DMC

• 2 other identifiers: IRB00010377R01MH083664
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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).

Conditions

Generalized Anxiety Disorder

Keywords

anxiety; rural; elderly

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline to week 13

• 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.

  baseline to week 13

Secondary Outcomes (5)

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

  baseline to week 13

• Pepper Center Tool for Disability (PCT-D)

  week 13

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

  week 13

• Insomnia Severity Index (ISI)

  week 13

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

  baseline to week 13

Study Arms (2)

Cognitive behavioral therapy

ACTIVE COMPARATOR

Cognitive-behavioral therapy consists of psychoeducation, relaxation techniques, cognitive therapy, problem-solving, thought stopping, behavioral activation, exposure, coping with pain, sleep, and relapse prevention

Behavioral: cognitive behavioral therapy

Nondirective supportive therapy

ACTIVE COMPARATOR

Nondirective supportive therapy consists of providing a warm and accepting environment in which a person can reflect on their experiences, thoughts, and feelings

Behavioral: nondirective supportive therapy

Interventions

cognitive behavioral therapy BEHAVIORAL

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

Also known as: CBT

Cognitive behavioral therapy

nondirective supportive therapy BEHAVIORAL

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

Also known as: NST

Nondirective supportive therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years GAD Reside in rural county Proficient in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• Brenes GA, Danhauer SC, Lyles MF, Hogan PE, Miller ME. Telephone-Delivered Cognitive Behavioral Therapy and Telephone-Delivered Nondirective Supportive Therapy for Rural Older Adults With Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Oct;72(10):1012-20. doi: 10.1001/jamapsychiatry.2015.1154.

  PMID: 26244854 DERIVED

• Brenes GA, Danhauer SC, Lyles MF, Miller ME. Telephone-delivered psychotherapy for rural-dwelling older adults with generalized anxiety disorder: study protocol of a randomized controlled trial. BMC Psychiatry. 2014 Feb 8;14:34. doi: 10.1186/1471-244X-14-34.

  PMID: 24506950 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Gretchen A. Brenes, Ph.D.
• Organization: Wake Forest School of Medicine

gbrenes@wakehealth.edu

336-716-4551

Study Officials

• Gretchen A. Brenes, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: December 14, 2010
• Study Start: January 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 29, 2018
• Results First Posted: October 3, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)