Internet Psychotherapy for Bipolar Disorder in Primary Care
2020年1月3日 更新者:Holly Swartz、University of Pittsburgh
Internet Psychotherapy for Treating Bipolar Disorder in Primary Care
The investigators will conduct a small pilot study to test the feasibility and acceptability of treating bipolar disorder (BP) in primary care with online psychotherapy delivered both with and without telephone, text, and email support from a clinical helper (CH).
The ultimate goal of this work is to provide preliminary data needed to design a larger scale effectiveness study of online psychotherapy for treating BP in primary care.
調査の概要
詳細な説明
Over a third of individuals with bipolar spectrum disorders (BP) are treated exclusively in primary care settings, and yet, primary care providers (PCPs) are ill-equipped to manage this complex and disabling illness.
Medications, which can be prescribed by PCPs, hasten recovery from illness and improve long-term course of illness for those with BP, but relapse and residual symptoms are common when individuals are treated with pharmacotherapy alone.
Best practices treatment for BP includes adjunctive, BP-specific psychotherapy as a key element of effective care.
And yet, evidence-based BP-specific psychotherapies that engage and modify targets specific to BP are typically unavailable in primary care settings.
Online interventions have the potential to overcome barriers to accessing evidence-based psychosocial treatments for BP in primary care.
In other settings and with other populations, effectiveness of online interventions improved when human support/coaching (clinical helpers; CH) via text, email, and telephone was added to the intervention.
Interpersonal and Social Rhythm Therapy (IPSRT) is a BP-specific psychotherapy that uses a problem-solving approach to help individuals regularize their social rhythms in order to entrain underlying disturbances in circadian and sleep/wake regulation, factors that are increasingly recognized as playing important roles in the pathogenesis of BP.
Its primary behavioral target is regularity of daily routines such as sleep/wake cycle and mealtimes.
This construct is measured by the validated Social Rhythm Metric (SRM).
The current project seeks to develop and conduct initial testing of an online version of IPSRT (i-IPSRT) for use in primary care.
We will (1) evaluate the feasibility and acceptability of supported and unsupported online psychotherapy interventions for BP in primary care (i-IPSRT and i-IPSRT plus CH) compared to Control Condition (CC), (2) examine whether i-IPSRT and i-IPSRT + CH engages its primary behavioral target as measured by the SRM, and (3) explore the impact of i-IPSRT, i-IPSRT + CH, and CC on symptoms and functioning over 12 weeks.
Information from this study will inform a larger trial to test the effectiveness of these approaches in primary care.
The public health impact of developing an effective, technology-enabled approach to delivering evidenced-based psychotherapy that targets specific, modifiable, behaviors for BP in primary care settings is substantial, offering the potential to reduce illness burden and improve outcomes for individuals with this disabling disorder.
研究の種類
介入
入学 (実際)
47
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~99年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- 18 years and older;
- meet DSM 5 criteria for bipolar disorder I, II or Other Specified Bipolar and Related Disorder;
- using the SCID 5;
- score > or = to 9 on Patient Health Questionnaire-9 or score > or = 155 on Internal State Scale;
- receiving care from a Primary Care Physician in a designated study site;
- access to broadband Internet connection and telephone; and
- ability to read and speak English.
Exclusion Criteria:
- Self-reported visual impairment that would prevent completion of study procedures;
- Psychotic disorder, substance use disorder or current manic episode, which would deem participation in the study either inappropriate or dangerous;
- currently receiving specialty mental health services for bipolar disorder from a psychiatrist or therapist;
- planning to leave Primary Care Practice within next 3 months; and
- active suicidal ideation.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:階乗代入
- 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:i-IPSRT
Participants randomized to this arm will complete bi-weekly i-IPSRT modules over the course of 12 weeks and they will track their mood and SRM's via smartphones or computer.
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internet IPSRT (a form of psychotherapy for individuals with bipolar disorder) will be offered via 12 specially-designed modules. CH will have participated in a two day training about Bipolar Disorder and IPSRT.
他の名前:
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実験的:i-IPSRT + CH
Participants randomized to this arm will complete bi-weekly i-IPSRT modules over the course of 12 weeks and they will track their mood and SRM's via smartphones or computer.
Additionally, i-IPSRT support will be delivered by Clinical Helpers, who will reach out to participants in this arm via 5-10 minute weekly phone calls.
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internet IPSRT (a form of psychotherapy for individuals with bipolar disorder) will be offered via 12 specially-designed modules. CH will have participated in a two day training about Bipolar Disorder and IPSRT.
他の名前:
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他の:CC (Controlled Condition)
Participants randomized to this arm will receive brief written psychoeducational material that includes information about social rhythm regularity.
This information will be either mailed or e-mailed to them.
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Written material about the importance of social rhythm regularity to mood stability in bipolar disorder
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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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Client-Satisfaction Questionnaire
時間枠:Up to Week 12
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measure of client satisfaction
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Up to Week 12
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Social Rhythm Metric (measure of lifestyle regularity)
時間枠:Up to 12 weeks
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measure of lifestyle regularity
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Up to 12 weeks
|
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Supportive Accountability Questionnaire
時間枠:Up to Week 12
|
assesses level of perceived accountability to another person for treatment participation
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Up to Week 12
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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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Quick Inventory of Depressive Symptoms
時間枠:up to 12 weeks
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measure of depressive symptoms
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up to 12 weeks
|
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Internal State Scale
時間枠:up to 12 weeks
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measure of mood symptoms
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up to 12 weeks
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Short Form-12
時間枠:up to 12 weeks
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measure of overall health status
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up to 12 weeks
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Functional Assessment Short Test
時間枠:up to 12 weeks
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assessment of impairment in functioning
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up to 12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Holly A Swartz, MD、University of Pittsburgh
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年3月1日
一次修了 (実際)
2019年4月30日
研究の完了 (実際)
2019年9月30日
試験登録日
最初に提出
2015年5月13日
QC基準を満たした最初の提出物
2015年5月14日
最初の投稿 (見積もり)
2015年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月7日
QC基準を満たした最後の更新が送信されました
2020年1月3日
最終確認日
2020年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 00085129000
- R34MH107541 (米国 NIH グラント/契約)
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。
双極性障害の臨床試験
i-IPSRTの臨床試験
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University of PittsburghThe Depressive and Bipolar Disorder Alternative Treatment Foundation完了
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University of PittsburghNational Alliance for Research on Schizophrenia and Depression完了
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University of WashingtonNational Institute of Mental Health (NIMH)完了
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University of PittsburghNational Institute of Mental Health (NIMH)募集