Living Well With Stroke

NCT01133106 | Completed

• 2 other identifiers: 37952-JR01NR007755
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to conduct a three-armed randomized controlled trial (RCT) in stroke survivors with depression to determine if a brief psychosocial-behavioral therapy intervention delivered in-person (arm A) or by telephone (arm B) is better than usual care (arm C), in terms of percent reduction in depressive symptoms and % of participants achieving remission of symptoms.

Conditions

Cerebrovascular Stroke; Depression

Keywords

stroke recovery; quality of life

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression (HRSD)

  Remission is defined as an HRSD score of 9 or less on the 17 item scale

  1 year post-treatment

Secondary Outcomes (1)

• Stroke Impact Scale (SIS)

  1 year post treatment

Study Arms (3)

In-person behavioral intervention

EXPERIMENTAL

behavioral counseling plus antidepressant treatment prescribed by participant's own provider; consisted of orientation session plus 6 counseling sessions in person with a psychosocial nurse practitioner

Behavioral: Brief pleasurable events/behavioral therapy

Telephone behavioral intervention

EXPERIMENTAL

This arm is identical to the in-person Arm except that the intervention is delivered by telephone instead of in-person.

Behavioral: Brief pleasurable events/behavioral therapy

Standard care

ACTIVE COMPARATOR

participants have orientation to the study with the same written materials given those in the experimental arms. Keep a medication log and keep appointments with their own post-stroke provider

Other: Standard care

Interventions

Brief pleasurable events/behavioral therapy BEHAVIORAL

Each participant in any arm will be given an American Stroke Association article about stroke and depression, a Stroke Smart Article about caregiver depression, and a pamphlet by the Beck Institute titled "Coping with Depression". Each participant in Arms 1 and 2 will be given their own manual for the intervention sessions. The intervention consists of one in-person orientation session and 6 weekly sessions with the following topics introducing behavioral therapy, the role of pleasant events, problem-solving skills and generalization techniques. All participants' primary care provider or stroke care provider will receive a letter informing them of their patient's participation (but not of study assignment). This letter will include recommendations for prescribing and adjusting antidepressant treatment using established guidelines adapted for treatment of medically-ill outpatients.

In-person behavioral intervention; Telephone behavioral intervention

Standard care OTHER

The standard care group (Arm C, N=75) will receive standard medical treatment from their provider, including a recommendation for antidepressants. Participants or third-party payers will pay for their antidepressants, just as they would under regular care. All participants receive written materials regarding depression from the American Stroke Association, keep medication logs and receive follow-up assessment on the same time frame as the intervention groups

Standard care

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalized for an ischemic or hemorrhagic stroke (intraparenchymal hemorrhage- IPH or subarachnoid hemorrhage - SAH) in the past 3 months
• clinical depression symptoms (Geriatric Depression Score -GDS \>= 11

You may not qualify if:

• major psychiatric co-morbidity
• active suicidal ideation without ability to contract for safety
• current substance abuse
• physical inability to tolerate 1-2 hour sessions
• receptive or global aphasia
• reduced level of consciousness (GCS\<15).

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195-7266, United States

Location

Related Publications (7)

• Mitchell PH, Veith RC, Becker KJ, Buzaitis A, Cain KC, Fruin M, Tirschwell D, Teri L. Brief psychosocial-behavioral intervention with antidepressant reduces poststroke depression significantly more than usual care with antidepressant: living well with stroke: randomized, controlled trial. Stroke. 2009 Sep;40(9):3073-8. doi: 10.1161/STROKEAHA.109.549808. Epub 2009 Aug 6.

  PMID: 19661478 BACKGROUND

• Mitchell PH, Teri L, Veith R, Buzaitis A, Tirschwell D, Becker K, Fruin M, Kohen R, Cain KC. Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression. J Stroke Cerebrovasc Dis. 2008 May-Jun;17(3):109-15. doi: 10.1016/j.jstrokecerebrovasdis.2007.12.002.

  PMID: 18436150 BACKGROUND

• Kirkness, CJ, Buzaitis, A, Habermann, B, Jessup, NM, McClennon, SM, McKenzie, S, Weaver, M, Weisman, P, Mitchell PH, Bakas, T. (2014) Methodological issues in telephone interventions for stroke survivors and family caregivers. Abstract 86. Stroke. 45(Suppl_1) (Supplement 1):A86, February 2014

  RESULT

• Kirkness CJ, Becker KJ, Cain KC, Kohen, R, Tirschwell, DL, Teri L, Veith RR, Mitchell PH (2015) Telephone versus in-person psychosocial behavioral treatment in post-stroke depression. Abstract WP:125. Stroke 46 (supplement 1): WP 125, February 2015. http://stroke.ahajournals.org/content/46/Suppl_1/AWP125.abstract?sid=441a6914-e14e-4969-85f9-964367d56ed7

  RESULT

• Byun E, Becker KJ, Kohen R, Kirkness CJ, Mitchell PH. Brief Psychosocial Intervention to Address Poststroke Depression May Also Benefit Fatigue and Sleep-Wake Disturbance. Rehabil Nurs. 2021 Jul-Aug 01;46(4):222-231. doi: 10.1097/RNJ.0000000000000304.

  PMID: 33443981 DERIVED

• Byun E, Kohen R, Becker KJ, Kirkness CJ, Khot S, Mitchell PH. Stroke impact symptoms are associated with sleep-related impairment. Heart Lung. 2020 Mar-Apr;49(2):117-122. doi: 10.1016/j.hrtlng.2019.10.010. Epub 2019 Dec 12.

  PMID: 31839325 DERIVED

• Kirkness CJ, Cain KC, Becker KJ, Tirschwell DL, Buzaitis AM, Weisman PL, McKenzie S, Teri L, Kohen R, Veith RC, Mitchell PH. Randomized trial of telephone versus in-person delivery of a brief psychosocial intervention in post-stroke depression. BMC Res Notes. 2017 Oct 10;10(1):500. doi: 10.1186/s13104-017-2819-y.

  PMID: 29017589 DERIVED

MeSH Terms

Conditions

Stroke; Depression

Interventions

Behavior Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pamela H Mitchell, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Catherine J Kirkness, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 23, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)