DepressionNCT02276807
Improving Mood in Veterans in Primary Care
A study testing Brief Behavioral Activation in people with Depression, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
The purpose of the Improving Mood in Veterans in Primary Care (IIR 14-047) is to evaluate a brief educational individual workshop that is meant to help Veterans better understand feelings of sadness and ways to improve their mood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Brief Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Mar 2015to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans:
- aged 18 years
- seeking or receiving primary care services at the Syracuse, Canandaigua, or Buffalo VA Medical Centers
- reporting at least moderate depressive symptoms
- stable course of antidepression medications
- stable course of outpatient treatment for anxiety or substance use disorders
Who cannot join
- Veterans who are:
- unable to demonstrate an understanding of the informed consent
- non-English speaking
- reporting imminent risk of suicide
- have an unstable psychiatric condition
- currently involved in treatment for depression
- recently started antidepression medication or outpatient treatment for anxiety or substance use disorder
- currently involved or completed inpatient or intensive outpatient treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215
Canandaigua VA Medical Center, Canandaigua, NY
Canandaigua, New York, 14424
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210
About this study
Official title: RCT of Behavioral Activation for Depression and Suicidality in Primary Care
The purpose of the Improving Mood in Veterans in Primary Care (IIR 14-047) is to evaluate a brief educational individual workshop that is meant to help Veterans better understand feelings of sadness and ways to improve their mood. This study is intended to evaluate and establish the workshop's effectiveness for use with Veterans in primary care settings.
The study involves up to 6 in-person meetings and 6 telephone interviews across a 6-month period of time. Approximately 144 Veterans will participate in the study. Using a procedure like the flip of a coin, the participants will have a one in two chance of receiving the brief educational workshop or treatment as usual condition.
Read the detailed description
Background:
Depressive symptoms are the most common referral problem to integrated mental health providers within Veteran primary care clinics. Although there exist several empirically-based brief psychotherapies for depression in primary care, the most significant barrier to providing those psychotherapies is treatment duration (e.g., the treatments range from 6-8 sessions of 30-50 minutes) as it does not match typical treatment formats delivered by mental health providers working in primary care (i.e., 1-4 15-30 minute sessions). Therefore, this HSR\&D study titled, RCT of Behavioral Activation for Depression and Suicidality in Primary Care, will examine the effectiveness of a brief version of an existing efficacious longer treatment for depression, called behavioral activation.
Objectives:
The overarching objectives of this study are to: 1) examine whether a 4-session manualized behavioral activation intervention (BA-PC) compared to Treatment as Usual (TAU) is effective in reducing self-reported depressive symptoms and subjective secondary outcomes such as sleep impairment and quality of life; 2) examine patient satisfaction, engagement, and receptivity to a 4-session BA-PC; and 3) explore the impact of BA-PC on suicidal ideation.
Methods:
The study will achieve these objectives using a randomized, controlled trial study design that has two conditions (4-session BA-PC and Treatment as Usual). Veterans will be recruited from three VA primary care settings in the Western portion of VISN 2 (Syracuse, Rochester, and Buffalo). The primary inclusion criteria for the study will be a report of depressive symptoms by primary care patients, who are not currently engaged in psychological treatment for depression. A total of 136 Veterans will be targeted for randomization. All Veterans will be assessed every 2 weeks for changes in mood and more comprehensive assessments will be completed at 6, 12, and 24 weeks.
Status:
Recruitment has ended as of 2/26/18 with 140 participants being randomized. Follow-up will continue for another 24 weeks. We are preparing the data for analysis.
- Conditions
- Depression
- Being tested
- Brief Behavioral Activation, Usual Care
- Keywords
- Depression, Behavioral Symptoms, Mental Disorders, Depressive Disorder, suicidal ideation, primary health care, Veterans
- Medical subject headings
- Depression, Behavioral Symptoms, Mental Disorders, Depressive Disorder, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral ActivationBehavioural
This is a 4-session individual workshop using behavioral activation techniques.
Usual CareOther
Also called Usual Care condition
Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Activation | Experimental | This is a 4-session individual workshop using behavioral activation techniques. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. Receives: Behavioral: Brief Behavioral Activation |
| Usual Care | Active comparator | This is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Depressive Symptoms at 12 Weeks
The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms at baseline and 12 weeks. The minimum value is 0 and the maximum value is 27. Higher scores mean a worse outcome.
Measured: Baseline and 12 weeks
Secondary outcomes (3)
Change From Baseline in Quality of Life at 12 Weeks
The investigators will use the Short Form-12 (SF-12) mental health domain to assess quality of life at baseline and 12 weeks. The minimum score is 0 and maximum score is 100. Higher scores mean better quality of life within mental health domain.
Measured: Baseline and 12 weeks
Change From Baseline in Sleep Disturbances at 12 Weeks
The investigators will use the Insomnia Severity Index (ISI) to assess sleep disturbances at baseline and 12 weeks. The minimum score is 0 and the maximum score is 28. Higher scores on ISI mean worse sleep.
Measured: Baseline and 12 weeks
Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks
The investigators will use the Environmental Observational Reward (EROS) scale to assess level of reward/positive mood at baseline and 12 weeks. The minimum score is 10 and the maximum score is 40. Higher scores mean increased level of positive mood obtained from environment.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study start23 Mar 2015
- Primary completion1 Mar 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer Schum Funderburk, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276807
- Sponsor's protocol ID
- IIR 14-047
- Status last verified
- Jun 2019
- First submitted
- 8 Oct 2014
- Last updated
- 1 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Funderburk JS, Pigeon WR, Shepardson RL, Wade M, Acker J, Fivecoat H, Wray LO, Maisto SA. Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. J Affect Disord. 2021 Mar 15;283:11-19. doi: 10.1016/j.jad.2021.01.033. Epub 2021 Jan 14.
PubMed 33516082
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Behavioral Activation for Depression and Suicidality in Primary Care
- ClinicalTrials.gov ID
- NCT02276807
- Acronym / sponsor ID
- IIR 14-047
- Conditions
- Depression
- Keywords
- Depression, Behavioral Symptoms, Mental Disorders, Depressive Disorder, suicidal ideation, primary health care, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Posted 14 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Improving Mood in Veterans in Primary Care (IIR 14-047) is to evaluate a brief educational individual workshop that is meant to help Veterans better understand feelings of sadness and ways to improve their mood. This study is intended to evaluate and establish the workshop's effectiveness for use with Veterans in primary care settings.
The study involves up to 6 in-person meetings and 6 telephone interviews across a 6-month period of time. Approximately 144 Veterans will participate in the study. Using a procedure like the flip of a coin, the participants will have a one in two chance of receiving the brief educational workshop or treatment as usual condition.
Detailed description
Background:
Depressive symptoms are the most common referral problem to integrated mental health providers within Veteran primary care clinics. Although there exist several empirically-based brief psychotherapies for depression in primary care, the most significant barrier to providing those psychotherapies is treatment duration (e.g., the treatments range from 6-8 sessions of 30-50 minutes) as it does not match typical treatment formats delivered by mental health providers working in primary care (i.e., 1-4 15-30 minute sessions). Therefore, this HSR\&D study titled, RCT of Behavioral Activation for Depression and Suicidality in Primary Care, will examine the effectiveness of a brief version of an existing efficacious longer treatment for depression, called behavioral activation.
Objectives:
The overarching objectives of this study are to: 1) examine whether a 4-session manualized behavioral activation intervention (BA-PC) compared to Treatment as Usual (TAU) is effective in reducing self-reported depressive symptoms and subjective secondary outcomes such as sleep impairment and quality of life; 2) examine patient satisfaction, engagement, and receptivity to a 4-session BA-PC; and 3) explore the impact of BA-PC on suicidal ideation.
Methods:
The study will achieve these objectives using a randomized, controlled trial study design that has two conditions (4-session BA-PC and Treatment as Usual). Veterans will be recruited from three VA primary care settings in the Western portion of VISN 2 (Syracuse, Rochester, and Buffalo). The primary inclusion criteria for the study will be a report of depressive symptoms by primary care patients, who are not currently engaged in psychological treatment for depression. A total of 136 Veterans will be targeted for randomization. All Veterans will be assessed every 2 weeks for changes in mood and more comprehensive assessments will be completed at 6, 12, and 24 weeks.
Status:
Recruitment has ended as of 2/26/18 with 140 participants being randomized. Follow-up will continue for another 24 weeks. We are preparing the data for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Activation | Experimental | Behavioral: Brief Behavioral ActivationThis is a 4-session individual workshop using behavioral activation techniques. Emphasis is placed upon understanding the individuals values and increasing the number of pleasurable activities aligned with the individuals values. |
| Usual Care | Active comparator | Other: Usual CareThis is the usual care condition, where participants often times will be provided with brief treatment in primary care that can take many forms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18 years
- seeking or receiving primary care services at the Syracuse, Canandaigua, or Buffalo VA Medical Centers
- reporting at least moderate depressive symptoms
- stable course of antidepression medications
- stable course of outpatient treatment for anxiety or substance use disorders
Key exclusion criteria (8 listed)
- unable to demonstrate an understanding of the informed consent
- non-English speaking
- reporting imminent risk of suicide
- have an unstable psychiatric condition
- currently involved in treatment for depression
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 Behavioral ActivationThis is a 4-session individual workshop using behavioral activation techniques. | Behavioural | Brief Behavioral Activation |
| Usual CareAlso: Usual Care conditionPrimary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care. | Other | Usual Care |
Primary outcome
Change From Baseline in Depressive Symptoms at 12 Weeks
Time frame: Baseline and 12 weeks
The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms at baseline and 12 weeks. The minimum value is 0 and the maximum value is 27. Higher scores mean a worse outcome.
3 secondary outcomes
Change From Baseline in Quality of Life at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in Sleep Disturbances at 12 Weeks
Time frame: Baseline and 12 weeks
Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33516082Funderburk JS, Pigeon WR, Shepardson RL, Wade M, Acker J, Fivecoat H, Wray LO, Maisto SA. Treating depressive symptoms among veterans in primary care: A multi-site RCT of brief behavioral activation. J Affect Disord. 2021 Mar 15;283:11-19. doi: 10.1016/j.jad.2021.01.033. Epub 2021 Jan 14.
- The co-PI's are affiliated with the VA Center for Integrated Healthcare and this website describes current and past research projects similar to the one in this study.Link provided by the sponsor.
- Click here for more information about this study: RCT of Behavioral Activation for Depression and Suicidality in Primary CareLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jennifer Schum Funderburk, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Activation in people with Depression, run by VA Office of Research and Development at 3 sites 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 6 inclusion and 8 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 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Depressive Symptoms at 12 Weeks (time frame: Baseline and 12 weeks). 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 NCT02276807, which also lists 1 linked publication.
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 1 Jul 2019.