Cerebrovascular StrokePSD2NCT01133106
Living Well With Stroke
A study testing Brief pleasurable events/behavioral therapy in people with Cerebrovascular Stroke and Depression, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cerebrovascular Stroke, Depression
- What is being tested?
- Brief pleasurable events/behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 98195-7266
About this study
Official title: Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD)
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.
Read the detailed description
This is the second phase of a study whose aim was to evaluate the short and long-term efficacy of a brief psychosocial/behavioral intervention (with adjunctive antidepressant)for the treatment of post-stroke depression (PSD) in survivors of ischemic stroke (registered as clinical trail NCT00194454). In the earlier trial we demonstrated that a pleasant event/problem-solving brief psychosocial-behavioral therapy delivered by psychosocial nurse practitioners was highly effective in treating major depression and promoting remission in ischemic stroke survivors for up to two years. In this phase, we refine the protocol, and potentially make it more cost effective, by conducting a randomized comparative effectiveness trial of in-person versus telephone delivery of the intervention, comparing with usual care control. We also seek to expand our sample to include hemorrhagic stroke survivors (intraparenchymal hemorrhage and subarachnoid hemorrhage) as well as those with ischemic stroke.
- Conditions
- Cerebrovascular Stroke, Depression
- Being tested
- Brief pleasurable events/behavioral therapy, Standard care
- Keywords
- stroke recovery, quality of life
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief pleasurable events/behavioral therapyBehavioural
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.
Standard careOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HRSD)
Remission is defined as an HRSD score of 9 or less on the 17 item scale
Measured: 1 year post-treatment
Secondary outcomes (1)
Stroke Impact Scale (SIS)
The SIS has multiple scales measuring limitations in activity, in social participation and perceived overall stroke impact (perceived percent recovery)
Measured: 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Pamela Mitchell, University of Washington
- Investigators
- Pamela H Mitchell, PhD, Principal investigator, University of WashingtonCatherine J Kirkness, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133106
- Sponsor's protocol ID
- 37952-J
- Other IDs
- R01NR007755
- Acronym
- PSD2
- Status last verified
- May 2016
- First submitted
- 26 May 2010
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: de-identified data will be provided to qualified investigators, including students conducting secondary analysis
Publications
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.
PubMed 19661478Mitchell 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.
PubMed 18436150Kirkness, 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
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
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.
PubMed 33443981Byun 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.
PubMed 31839325Kirkness 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.
PubMed 29017589
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD)
- ClinicalTrials.gov ID
- NCT01133106
- Acronym / sponsor ID
- PSD2 / 37952-J
- Conditions
- Cerebrovascular Stroke, Depression
- Keywords
- stroke recovery, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- May 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is the second phase of a study whose aim was to evaluate the short and long-term efficacy of a brief psychosocial/behavioral intervention (with adjunctive antidepressant)for the treatment of post-stroke depression (PSD) in survivors of ischemic stroke (registered as clinical trail NCT00194454). In the earlier trial we demonstrated that a pleasant event/problem-solving brief psychosocial-behavioral therapy delivered by psychosocial nurse practitioners was highly effective in treating major depression and promoting remission in ischemic stroke survivors for up to two years. In this phase, we refine the protocol, and potentially make it more cost effective, by conducting a randomized comparative effectiveness trial of in-person versus telephone delivery of the intervention, comparing with usual care control. We also seek to expand our sample to include hemorrhagic stroke survivors (intraparenchymal hemorrhage and subarachnoid hemorrhage) as well as those with ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-person behavioral intervention | Experimental | Behavioral: Brief pleasurable events/behavioral therapybehavioral 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 |
| Telephone behavioral intervention | Experimental | Behavioral: Brief pleasurable events/behavioral therapyThis arm is identical to the in-person Arm except that the intervention is delivered by telephone instead of in-person. |
| Standard care | Active comparator | Other: Standard careparticipants 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 |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief pleasurable events/behavioral therapyEach 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. | Behavioural | In-person behavioral intervention, Telephone behavioral intervention |
| Standard careThe 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 | Other | Standard care |
Primary outcome
Hamilton Rating Scale for Depression (HRSD)
Time frame: 1 year post-treatment
Remission is defined as an HRSD score of 9 or less on the 17 item scale
1 secondary outcome
Stroke Impact Scale (SIS)
Time frame: 1 year post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Background: PubMed 19661478Mitchell 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.
- Background: PubMed 18436150Mitchell 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.
- Results publicationKirkness, 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
- Results publicationKirkness 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
- Derived from this study: PubMed 33443981Byun 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.
- Derived from this study: PubMed 31839325Byun 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.
- Derived from this study: PubMed 29017589Kirkness 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.
- Individual participant dataSharing planned: Yes. de-identified data will be provided to qualified investigators, including students conducting secondary analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela H Mitchell, PhD principal investigator
University of Washington
Catherine J Kirkness, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief pleasurable events/behavioral therapy in people with Cerebrovascular Stroke and Depression, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HRSD) (time frame: 1 year post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01133106, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.