心理的苦痛を抱える一次医療退役軍人向けのピアサポート付きモバイルヘルス適応型介入の試験 (Peer mHealth)
心理的苦痛を抱える一次医療退役軍人向けピアサポート型モバイルヘルスの適応的介入の試験
Many Veterans experience psychological distress including depression, post-traumatic stress disorder (PTSD), anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Background: Psychological distress in Veterans Affairs (VA) primary care patients is common and often not adequately treated. The VA has a suite of evidence-informed mobile health applications (mHealth apps) for psychological distress that are frequently downloaded, but most Veterans do not use them enough to experience health benefits. Support from helping professionals, such as peer specialists, can increase app use and health benefits. The study team found that peer-supported mHealth is feasible to deliver in VA primary care, increases app engagement and is associated with high satisfaction and improved Veteran health. However, not all individuals need the same amount of support when using mHealth. This study will test an adaptive intervention using a SMART design to match patient need with specific doses of peer support for mHealth.
Significance: The long-term goal is to improve the health of Veterans with psychological distress by developing a brief and efficient stepped-care intervention that can be feasibly implemented in VA primary care settings. This proposal is highly aligned with the priorities of the operational partners in the Offices of Mental Health and Patient Centered Care & Cultural Transformation and VA BBMH. The findings will support the VA-wide expansion of the Peers in PACT program, per recent STRONG Act legislation.
Innovation & Impact: Key innovations include the use of a SMART design to develop an adaptive intervention for a high-priority patient population and the novel application of the Supportive Accountability model in which human support is critical to enhancing adherence to mHealth interventions. The proposal will also provide much needed data on the effectiveness of peers to deliver brief, structured interventions.
Specific Aims: 1) Test the effectiveness of a) stage 1 (Peer mHealth vs. Self-Managed mHealth), b) stage 2 interventions (4 sessions of Peer mHealth vs. Peer Whole Health) among slow responders and c) the embedded stepped-care treatment sequences on psychological distress and secondary outcomes (e.g., app use, cost, mental health service use, symptoms, functioning) at 12 weeks. 2) Examine candidate tailoring variables as predictors of outcomes in a) stage 1 (i.e., motivation, coping self-efficacy) and b) stage 2 (i.e., app use and unmet social needs). Race/ethnicity and sex/gender will also be explored as moderators. 3) Assess barriers and facilitators to implementing adaptive interventions for peer mHealth in PACT by interviewing key VHA leadership, staff and Veteran stakeholders.
Methodology: Participants (N=384) with significant psychological distress who are not engaged in specialty mental health care will be randomized at Stage 1 to receive either Self-Managed mHealth or one peer phone call to support mHealth. Participant response, defined as a reliable decrease in psychological distress (5-point decrease in any DASS-21 subscale) will be measured after 4 weeks. Stage 2 randomization will assign slow responders to step-up to additional mHealth peer phone calls or an alternative peer support model (peer-delivered Whole Health). Stage 1 early responders will continue/ step-down to Self-Managed mHealth. All participants will be reassessed at 12, 16 and 24 weeks post-enrollment. Psychological distress is the primary outcome. Secondary outcomes include app use, mental health service use, cost, psychological symptoms (e.g., depression, anxiety, stress, PTSD, anger, sleep), and functioning (e.g., social functioning).
Next Steps/ Implementation: Should these results support the effectiveness of the adaptive intervention, the investigators will disseminate peer training through the Peers in PACT and Tech into Care VA networks. The investigators will also prepare a new ORD application to systemically investigate how the adaptive intervention can be implemented in VA.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Kyle Possemato, PhD
- 電話番号：53551 (315) 425-4400
- メール：kyle.possemato@va.gov
研究場所
-
-
California
-
Palo Alto、California、アメリカ、94304-1207
- まだ募集していません
- VA Palo Alto Health Care System, Palo Alto, CA
-
コンタクト：
- Jennifer Smith
- メール：Jennifer.Smith@va.gov
-
-
Massachusetts
-
Bedford、Massachusetts、アメリカ、01730-1114
- まだ募集していません
- VA Bedford HealthCare System, Bedford, MA
-
コンタクト：
- Andrew Peckham
- メール：Andrew.Peckham@va.gov
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48105-2303
- まだ募集していません
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
コンタクト：
- Rebecca Sripada
- メール：Rebecca.Sripada@va.gov
-
-
New York
-
Syracuse、New York、アメリカ、13210-2716
- 募集
- Syracuse VA Medical Center, Syracuse, NY
-
コンタクト：
- Kyle Possemato, PhD
- 電話番号：53551 (315) 425-4400
- メール：kyle.possemato@va.gov
-
主任研究者：
- Kyle Possemato, PhD
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104-4551
- まだ募集していません
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
-
コンタクト：
- Travis Cos
- メール：travis.cos@va.gov
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Veteran enrolled in primary care at one of 3 VA facilities (Philadelphia, PA; Ann Arbor, MI; and Bedford, MA)
- clinically significant psychological distress on at least one DASS-21 subscale (Depression => 10, Anxiety => 8, Stress => 13)
Exclusion Criteria:
- symptoms that may preclude active engagement in the intervention such as gross cognitive impairment or current symptoms of mania or psychosis
- suicide risk as measured by the P4 Suicide Assessment
- plan to engage in psychotherapy during the intervention period
- started or changed the dose of a psychotropic medication in the last two months
- voice a preference to be directly referred to mental health specialty care
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Stage 1
Stage 1 randomization |
Patients use mHealth apps to manage psychological distress Patients receive one session with a peer while using mHealth apps to manage psychological distress |
|
実験的：Stage 2
Stage 2 randomization |
Patients use mHealth apps to manage psychological distress Patients receive 4 sessions with a peer while using mHealth apps to manage psychological distress Patients receive 4 session with a peer focused on Whole Health |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depression Anxiety and Stress Scale
時間枠：baseline to 24 weeks
|
Depression Anxiety and Stress Scale is a widely used measure of psychological distress consisting of 21 items measured on a 4-point scale. The total score ranges from 0-63. Higher scores indicate greater severity. |
baseline to 24 weeks
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Post Traumatic Stess Checklist-5
時間枠：baseline to 24 weeks
|
Self report measure assessing the 21 symptoms of post-traumatic stress disorder (PTSD) on a 5 point scale. Total score ranges from 0-105. Higher scores indicate greater severity. |
baseline to 24 weeks
|
|
Insomnia Severity Index
時間枠：baseline to 25 weeks
|
Self report measure assessing insomnia with 7 questions on a 5 point scale. Total score range from 0-28. Higher scores indicate greater severity. |
baseline to 25 weeks
|
|
Dimensions of Anger Reactions
時間枠：baseline to 24 weeks
|
Self report measure assessing anger with 5 items on a 5 point scale. Total score ranges from 5-25. Higher scores indicate greater severity. |
baseline to 24 weeks
|
|
Brief Inventory of Psychosocial Functioning
時間枠：baseline to 24 weeks
|
Self report measure of psychosocial functioning measured with 7 items on 7 point scale. Total ranges from 0-42. Higher scores indicate more dysfunction. |
baseline to 24 weeks
|
|
Satisfaction with Life Questionnaire
時間枠：baseline to 24 weeks
|
Self report measure assessing life satisfaction with 5 items on an eight point scale. Total score ranges from 5-35. High scores indicate greater satisfaction. |
baseline to 24 weeks
|
|
Client Satisfaction Questionnaire
時間枠：baseline to 24 weeks
|
Self report measure assessing participant satisfaction with study interventions with 8 items measures on a 4 point scale. Total score ranges from 0-24. Higher scores indicate greater satisfaction. |
baseline to 24 weeks
|
その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
University of Rhode Island Change Assessment
時間枠：baseline to 24 weeks
|
Self report measure assessing patient motivation to address psychological distress with 12 items on a 5 point scale. Total score ranges from 12 to 60. Higher scores indicate more motivation. |
baseline to 24 weeks
|
|
Coping Self Efficacy Scale
時間枠：baseline to 24 weeks
|
Self report measure to assess patient self efficacy to address psychological distress with 26 items on a 11 point scale. Total score ranges from 0-260 with higher scores indicating greater self-efficacy. |
baseline to 24 weeks
|
|
Assessing Circumstances and Offering Resources for Needs
時間枠：baseline to 24 weeks
|
Measure of unmet social needs that include 11 questions. The total score ranges from 0-48 with higher scores indicating more unmet needs. |
baseline to 24 weeks
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Kyle Possemato, PhD、Syracuse VA Medical Center, Syracuse, NY
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- HSR4-014-24W
- 1I01RD000522-01A2 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。