A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program (Restory)
Internetförmedlad Psykoterapi för Att Behandla Posttraumatiskt Stressyndrom Efter Sexuella övergrepp
調査の概要
詳細な説明
Restory has been developed to address the current lack of available, low-threshold treatment for sexual abuse victims. Restory is a free, anonymous, trauma-focused, iCBT program. iCBT has been shown to be as effective as face-to-face treatment for several conditions (Andersson et al., 2014). iCBT for PTSD has documented efficacy (Lewis et al., 2017; Litz et al., 2007), regardless of the patient's age (Paiva et al., 2024), and even intensive formats have proven feasible despite concerns about increased risk of dropout or symptom deterioration (Bragesjö et al., 2021). There are indications that internet-based treatment can even enhance the patient's sense of self-efficacy (Knaevelsrud et al., 2017) since they are encouraged to take on a more active role in their treatment, which is particularly beneficial for individuals with PTSD facing negative self-cognitions.
In a recent review of barriers to formal help-seeking following sexual victimization, Zinzow et al. (2021) concluded that increasing resource availability and access is crucial. iCBT can thus play a pivotal role in breaking down barriers by providing nationwide access to care, regardless of geographical location, thus democratizing access to specialized care for an underserved patient population. By offering treatment anonymously, we believe we can further promote help-seeking by mitigating the stigma, guilt shame, and confidentiality concerns that often hinder victims of sexual abuse from seeking care. This is valuable for the patient group at large, but particularly beneficial for victim groups that are less likely to seek help, including minority groups (racial, ethnical, and sexual minorities; Zinzow et al., 2021), boys and men (Donne et al., 2018), victims of female offenders (Jonsson & Svedin, 2019), and victims of technology-assisted sexual abuse (Joleby et al., 2024) as they may face heightened risk of experiencing shame, stigma, and cultural and social barriers. iCBT treatment can be conducted discreetly and flexibly online, accommodating the patient's schedule without the need for physical clinic visits, thereby reducing the risk of recognition. Overall, this approach aligns with the objective outlined by the Swedish Association of Local Authorities and Regions (SKR, 2020) to ensure equitable care nationwide and to better address the needs of particularly vulnerable groups.
An important aspect of Restory, and a gap it aims to fill, is that it is a treatment program specifically designed for a unique patient group: victims of sexual abuse. This is crucial because sexual victimization is often associated with fear, anxiety, and shame, making the quality of the therapeutic encounter essential. The lack of specialized clinics means that victims of sexual abuse are often left to seek care through a regular medical center or emergency room, where the medical staff do not have any specific training in meeting this patient group. Research has indicated that women disclosing to both informal and formal supports reported more negative (e.g. victim blaming and disbelief) than positive reactions (Kennedy & Prock, 2018). These negative reactions have in turn been linked to adverse outcomes such as PTSD, depression, psychological and physical distress, and maladaptive coping. Hence, it is imperative that specialized care is provided by knowledgeable staff (Kennedy & Prock, 2018), and ideally with a treatment program specifically tailored to the unique needs of the patient group.
The project implements Public and Patient Involvement (PPI) from start to finish of the project. Experts from organisations working with this patient, and a patient representative with lived experience of sexual abuse, are part of an Advisory Board providing feedback on the planning of the studies and in the development of the treatment program.
The target population is adult victims of sexual abuse suffering from post-traumatic stress disorder. Interested individuals will self-refer and register via the study platform (www.restorystudien.se).
A Project Plan and a Statistical Analysis Plan (SAP) was pre-registered at the OSF platform (https://osf.io/mxf7t/overview) before recruitment commenced.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Malin Joleby, PhD
- 電話番号:+46736971237
- メール:malin.joleby@ki.se
研究場所
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Stockholm、スウェーデン、11364
- 募集
- Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
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コンタクト:
- Malin Joleby, PhD
- 電話番号:+46736971237
- メール:malin.joleby@ki.se
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主任研究者:
- Malin Joleby, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
18+ years; exposure to sexual violence where a minimum of 1 month has passed since the incident; self-reported total PCL-5 of minimum 30; current stable dose of psychotropic medication (for at least 4 weeks) or medication free; sufficient Swedish skills; willingness and availability to participate.
Exclusion Criteria:
Ongoing trauma-related threat (e.g. living with a violent spouse); severe psychiatric illness requiring immediate alternative treatment (such as high acute suicide risk or presence of psychotic episode, assessed during screening interview); current participation in other trauma-focused CBT or Eye Movement Desensitization and Reprocessing therapy, current benzodiazepine treatment, no trauma memory.
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:並列代入
- 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:Restory
A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse
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Restory contains eight modules over eight weeks, and is a cognitive behavioral therapy program based on prolonged exposure (PE), specifically tailored for victims of sexual abuse.
The program comprises all core treatment elements in PE (Foa et al., 2021), together with added psychoeducation on aspects specifically relevant for this patient group (i.e.
shame, guilt, disgust, sexuality).
Each module contains psychoeducational text, a description of the how the treatment works, and instructions for homework assignments.
After completing a module and receiving personalized feedback from the therapist, the participant proceeds to the next module.
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介入なし:Waitlist
The waitlist control group will wait a minimum of nine weeks before starting active treatment (Restory).
During the waitlist period, the participant will be followed up, responding to the same set of questionnaires as participants in the treatment group.
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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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PTSD symptom severity score, as measured by PCL-5
時間枠:From baseline to end of treatment at 8 weeks
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Is Restory more effective than a waitlist control in reducing PTSD symptom severity score, as measured by PCL-5?
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From baseline to end of treatment at 8 weeks
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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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PTSD symptom severity score, as measured by the PTSD-part of the ITQ
時間枠:From baseline to end of treatment at 8 weeks
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Is Restory more effective than a waitlist control in reducing PTSD symptom severity score, as measured by the PTSD-part of the ITQ?
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From baseline to end of treatment at 8 weeks
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Complex-PTSD symptom severity score, as measured by the Disturbances in Self-Organization part of ITQ?
時間枠:From baseline to end of treatment at 8 weeks
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Is Restory more effective than a waitlist control in reducing Complex-PTSD symptom severity score, as measured by the Disturbances in Self-Organization part of ITQ?
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From baseline to end of treatment at 8 weeks
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Depressive symptoms, as measured by MADRS-S
時間枠:From baseline to end of treatment at 8 weeks
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Is Restory more effective than a waitlist control in reducing depressive symptoms, as measured by MADRS-S?
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From baseline to end of treatment at 8 weeks
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PTSD symptom severity score, as measured by the PCL-5 at 1- and 6-month follow-up
時間枠:From post treatment to 1-month and 6-month follow-up
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Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for PTSD symptom severity score, as measured by the PCL-5?
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From post treatment to 1-month and 6-month follow-up
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PTSD symptom severity score, as measured by the PTSD-part of the ITQ, at 1-month and 6-month follow-up
時間枠:From post treatment to 1-month and 6-month follow-up
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Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for PTSD symptom severity score, as measured by the PTSD-part of the ITQ?
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From post treatment to 1-month and 6-month follow-up
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Complex-PTSD symptom severity score, as measured by the Disturbances in Self- Organization part of ITQ at 1-month and 6-month follow-up
時間枠:Post treatment to 1-month and 6-month follow-up
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Are treatment gains from Restory maintained or improved at 1-month follow-up and 6-month follow up for Complex-PTSD symptom severity score, as measured by the Disturbances in Self- Organization part of ITQ?
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Post treatment to 1-month and 6-month follow-up
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Depressive symptoms, as measured by MADRS-S at 1-month an 6-month follow-up
時間枠:From after treatment to 1-month and 6-month follow-up
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Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for depressive symptoms, as measured by MADRS-S?
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From after treatment to 1-month and 6-month follow-up
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of life, measured with the AQoL-8D
時間枠:From baseline to end of treatment and 1-month and 6-month follow-up
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Is Restory more effective than a waitlist control in increasing quality of life, measured with the AQoL-8D?
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From baseline to end of treatment and 1-month and 6-month follow-up
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Trauma-related shame, measured with the TRSI-24
時間枠:From baseline to end of treatment and 1-month and 6-month follow-up
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Is Restory more effective than a waitlist control in reducing trauma-related shame, measured with the TRSI-24?
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From baseline to end of treatment and 1-month and 6-month follow-up
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Negative post-traumatic cognitions, measured with the PTCI-9
時間枠:From baseline to end of treatment and 1-month and 6-month follow-up
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Is Restory more effective than a waitlist control in reducing negative post-traumatic cognitions, measured with the PTCI-9?
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From baseline to end of treatment and 1-month and 6-month follow-up
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協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
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
- Dnr 2025-08612-01
- 2024-116 (その他の助成金/資金番号:Fredrik och Ingrid Thurings stiftelse)
- 04904/2024 (その他の助成金/資金番号:Brottsofferfonden)
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
Investigators who provide a methodologically sound proposal, and whose proposed use of the data has been approved by an independent review committee identified for this purpose. Any researcher may access the version of the data available in a public repository.
For what types of analyses? To achieve aims in the approved proposal and for meta-analysis
By what mechanism will data be made available? Proposals should be directed to the Data Access Unit at Karolinska Institutet.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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
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