Internet-Delivered Acceptance and Commitment Therapy (iACT) for Youth With PTSD and Chronic Pain
調査の概要
詳細な説明
Objective: The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT) for youth with PTSD and comorbid chronic pain.
Sample size: 5-10 participants.
Trial design: All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit at Skåne University Hospital. The unit is a government supported, regional specialist center focused on assessment and treatment of chronic pain and related disability.
Assessments: Baseline and post treatment (2 weeks after treatment) assessments will be conducted by an assessor who is trained to administer the study measures. Self-report measures will also be collected at this time, post treatment (2 weeks after treatment) as well as during a 3-month follow up.
Pre-and post assessment: Assessors will collect demographic information, self-report measures, and trauma history. During the pre- and post-assessment the Clinician-Administered PTSD Scale for DSM-5 will be administered to establish PTSD whether participants met the DSM-5 criteria for PTSD.
During the pre-assessment a clinical interview will be administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.
Post-treatment exit interview: At the post-assessment, the assigned assessor will ask participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.
During treatment: During treatment the treatment credibility scale will be administered to assess the patients' perceptions of how credible the treatment is following the introduction of the treatment rationale and the main treatment components (included in the internet program).
Safety parameters: As a mean to monitor safety and progress participants complete a short daily diary during the baseline and treatment phases. In addition, participants can report any adverse events during treatment, at post treatment and follow-up assessment.
Data collection: Self-report measures will be mailed to participants
A single-case design with daily data collection during a baseline phase (A) and an intervention phase (B) will also be used. The treatment intervention spans 10 weeks.
For the daily data collection, a shortened set of measures comprising approximately 10 items focusing on ptsd symptoms, psychological flexibility, and pain intensity will be used. Data will be collected via a digital platform, with secure handling of any personal data.
Main statistical analysis Between-group estimates on outcome will be conducted using repeated measurements. The analyses will be conducted using intention to treat principles and post hoc comparisons. Randomization test for the A/B single case data collection will be conducted.
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：Sophia Åkerblom, Associate professor
- 電話番号：0046707790415
- メール：sophia.akerblom@skane.se
研究場所
-
-
-
Lund、スウェーデン
- 募集
- Department of pain rehabilitation
-
コンタクト：
- Sophia Åkerblom, phd
- 電話番号：0046707790415
- メール：sophia.akerblom@skane.se
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion criteria
- a CAPS of ≥25 and a diagnosis of PTSD
- subjected to single traumatic events
- aged 15-24 years
- had symptoms of chronic pain that interfered significantly with everyday life
- were fully examined medically and had received medical treatment if indicated
- were able to be an active part of the rehabilitation process, regain functioning in different life areas and participate in treatment interventions for approximately 5 hours every week
- stable dose of medication
- able to read and write in Swedish
- had access to a smart phone or computer with internet access
Exclusion criteria
- repeated and extensive traumatic events
- had other acute or severe psychiatric disorders or symptoms that warranted designation as the primary disorder (ADHD, autism spectrum disorder, untreated bipolar disorder, OCD, psychotic symptoms, severe depression, )
- were actively abusing analgesic medications (including narcotics), alcohol or other drugs
- had great difficulty to harbour and handle strong emotions that could lead to self-harming behavior
- had health risks due to medical reasons
- had social or economic difficulties or lack of social support that hindered behavior change
- current severe suicidal ideation that warranted immediate intervention
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：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：iACT
|
The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance.
The treatment is delivered on a safe internet platform.
Participants have planned telephone contact with their assigned psychologist 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
|
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 |
|---|---|---|
|
PTSD symptom severity as measured by the the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
時間枠：Baseline, two-week-post treatment, 3 month-follow-up.
|
The scale ranges from 0-80 and higher sores indicate greater severity of PTSD symptoms.
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Baseline, two-week-post treatment, 3 month-follow-up.
|
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Psychological inflexibility
時間枠：Baseline, two-week-post treatment, 3 month-follow- up
|
As measured by the Psychological Inflexibility in Pain Scale (PIPS) (changes between assessments) Min=0; Max= 52.
Higher scores indicate worse inflexibility
|
Baseline, two-week-post treatment, 3 month-follow- up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anxiety and depression
時間枠：Baseline, two-week-post treatment, 3 month-follow up
|
As measured by the Hospital Anxiety and Depression Scale (HADS) (changes between assessments) Min= 0; Max= 21.
Higher scores indicate worse depression/anxiety.
|
Baseline, two-week-post treatment, 3 month-follow up
|
|
Pain intensity
時間枠：Baseline, two-week-post treatment, 3 month-follow- up
|
As measured by the Numerical Rating Scale (NRPS) (changes between assessments) Min= 0; Max= 10.
Higher scores indicate worse pain intensity.
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Baseline, two-week-post treatment, 3 month-follow- up
|
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General acceptance
時間枠：Baseline, two-week-post treatment, 3 month-follow-up
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As measured by the Swedish Acceptance and Action Questionnaire (SAAQ) (changes between assessments)
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Baseline, two-week-post treatment, 3 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 |
|---|---|---|
|
Parental psychological flexibility
時間枠：Baseline, two-week-post treatment, 3 month-follow-up
|
As measured by Parental Acceptance and Action Questionnaire (PAAQ)
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Baseline, two-week-post treatment, 3 month-follow-up
|
協力者と研究者
捜査官
- 主任研究者：Sophia Åkerblom, phd、Skane University Hospital
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
- SkaneU2026
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