Acceptance and Compassion to Enhance Self-care Pilot (ACES Pilot)
Development and Pilot of Positive Self-Reappraisal Emotion Regulation Intervention to Improve Self-Care Among HIV+ Substance Users
調査の概要
詳細な説明
Investigators will develop and refine a two-phase emotion regulation intervention. This process will involve 5 steps: 1) conducting 5-8 key informant interviews, including obtaining feedback on a drafted manual and materials from providers and case managers, 2) integrating the qualitative data, 3) running 2 participants through a condensed version of the intervention and obtaining feedback on the content, language, and text message interface, 4) integrating the additional feedback, and 5) conducting an open pilot with 10 participants to assess feasibility and acceptability of the revised intervention. The pilot will include 3 research assessment visits which will involve completion of self-report questionnaires using Qualtrics at baseline, within one week of completion of phase 1, and within one week of completing phase 2. Viral load (VL) will be assessed at baseline and at the final follow up.
Qualitative interviews. The investigators will conduct 5-8 semi-structured qualitative interviews with providers and case managers. Interviews will inquire about unmet psychological barriers to HIV-care, perceptions of proposed domains and text message questions and response options. All interviews will be recorded, transcribed and analyzed using thematic analysis. Prominent themes and suggestions brought up in the interviews will be integrated into the intervention materials and implementation.
Trial run of pilot. After integrating the feedback from the key informant interviews, investigators will recruit two participants to complete a condensed version of the intervention. After each of the 5 sessions, participants will be asked to complete perceived usefulness surveys. Both participants will then be interviewed to obtain feedback on the intervention. These interviews will be recorded, transcribed and analyzed using thematic analysis. Prominent themes and suggestions brought up in these interviews as well as logistic challenges will be integrated into the intervention materials and implementation procedures.
Text messages. Investigators will use questions adapted from a previously published personalized bi-directional text message intervention involving HIV+ substance users (TxText) to assess mood, adherence and substance use. Each participant will receive 3 texts/week inquiring about current mood over the course of the intervention. Additionally, in phase 2 each participant will receive weekly texts asking about their medication adherence. Given the stigmatized nature of substance use, investigators will use a coded query, adapted from TxText, which assess substance use in the form of a weather question. This coded query strategy has demonstrated feasibility and acceptability among a similar population of HIV+ active substance users. All participants will be reminded of the meaning of this question during phase 1. During the last in-person intervention visit, participants will identify 5 positive self-reappraisal statements and link them to response options to the mood query based on when they feel each would be most helpful in regulating their emotions. Throughout phase 2, participants will then receive their linked positive-self reappraisal statements in response to mood queries. Participants will then be asked to respond on a 6-point scale indicating how helpful the positive self-reappraisal was (0=extremely unhelpful to 5= extremely helpful), which will be used to assess engagement in phase 2 of the intervention.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
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:
- English-speaking
- HIV+
- ≥18 years old
- Able to complete informed consent
- Endorse polysubstance use in the past 2 months, excluding cannabis and tobacco
- Participants must own a cell phone with text message capacity and be willing to work with a study staff member to add minutes or money to their cell phone plan to cover the text-message component of the intervention (at no cost to participants).
- Consent to release their medical records, in order to assess engagement in HIV-care (i.e., attended/scheduled appointments).
Exclusion Criteria:
- Endorsement of active suicidality or psychosis on initial clinical interview.
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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ACES Pilot
This pilot will consist of 5 individual sessions and an innovative bi-directional text message component that uses participant-written positive self-statements informed by the intervention content (e.g., self-compassion, positive self-reappraisal and nonjudgmental acceptance).
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This pilot will consist of 5 individual sessions and an innovative bi-directional text message component that uses participant-written positive self-statements informed by the intervention content (e.g., self-compassion, positive self-reappraisal and nonjudgmental acceptance).
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline antiretroviral adherence to post intervention follow up visits
時間枠：Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).
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Participants will be asked to complete the Visual Analogue Scale (VAS) in person at baseline and subsequent research visits.
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Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).
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Change from baseline engagement in HIV-related Care (number of HIV-related health visits scheduled and attended) to follow up visits.
時間枠：Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).
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Participants will be asked to report the number of HIV-related health visits scheduled and attended.
Additionally, chart reviews will be conducted at the end of the study to determine the number of attended compared to scheduled HIV-related health visits.
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Collected at baseline, research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 13 months post-baseline).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline viral load to final follow up visit.
時間枠：Collected at baseline and approximately 21 months post-baseline at final research visit.
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Participants will have blood drawn for viral load tests at baseline and their final follow up visit.
The values will be compared.
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Collected at baseline and approximately 21 months post-baseline at final research visit.
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Change in substance use
時間枠：Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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The ASSIST measures substance use.
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Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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Change in baseline sexual risk behaviors to research visit after face-to-face intervention component (approximately 5 weeks post-baseline) and research visit after text-message component (approximately 11 months post-baseline).
時間枠：ssessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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Self-report questions to assess recent sexual risk behaviors.
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ssessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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Change in HIV and Abuse Related Shame (HARSI)
時間枠：Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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The HARSI is a self report measure that assesses HIV and abuse related shame
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Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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Change in depression (CES-D)
時間枠：Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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The CES-D will be used to assess self-reported depressive symptoms
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Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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Change in Self-Compassion (Self-Compassion Scale)
時間枠：Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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The Self-Compassion Scale will be used to assess self-reported self compassion
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Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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Change in mindfulness (Five Facet Mindfulness Questionnaire)
時間枠：Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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The Five Facet Mindfulness Questionnaire will be use to assess self-reported mindfulness
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Assessed at baseline, approximately 5 weeks post-baseline, approximately 13 months post-baseline and approximately 21 months post-baseline.
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協力者と研究者
捜査官
- 主任研究者：Abigail W Batchelder, PhD, MPH、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
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