Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Psychiatric Distress (TIPPS)
Tailored Internet-delivered Cognitive Behavioral Therapy for Patients With Chronic Pain and Comorbid Psychiatric Distress
This study is a randomized controlled trial studying the efficacy of an iCBT treatment for patients with chronic pain and comorbid psychiatric distress. Half the participants will receive treatment at first, while the other half serve as a control group. After the first group has received treatment, the same program will be offered to participants in the control group. Treatment will be tailored on the level of individual participants, enabling individuals suffering a wide range of problems to be recruited. The treatment will consist of a 10-week guided self-help program, followed by a booster program and follow-up one year later. During the curse of the treatment the participants will be guided via text communication by a licensed psychologist or a candidate psychologist on their last year of studies.
The primary hypothesis is that an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric distress. The investigators expect that patients in the treatment group will show reduced levels of disability, depression and anxiety, while improving on scales measuring coping and quality of life.
調査の概要
詳細な説明
Patients suffering from chronic pain often experience comorbid psychiatric distress. Cognitive behavioral therapy (CBT) has been shown to be effective in treating both these problems. However delivering relevant treatment can be difficult due to logistics, cost and lack of personnel with required competence. Delivering CBT though the internet (iCBT) is a novel approach, sidestepping logistical issues while lowering costs. This however, is an area were research is lacking, and though there are several studies showing iCBT to be efficacious in treating both pain and psychiatric conditions, research on a combined approach is scarce.
This study will primarily investigate whether an individually tailored CBT-treatment administered through the internet can be beneficial for patients suffering from chronic pain and comorbid psychiatric conditions. The project will also clarify whether a following booster-program, also administered tough the internet, is helpful in maintaining and increasing effects of the initial treatment. Lastly, analysis of possible mediating variables will be able to give insight into the internal workings of the treatment itself, further elucidating efficacy of specific interventions, data which will be useful in future developments of treatment design.
The treatment will be based on a previously developed program, devised to target depression and anxiety in patients with chronic pain. The treatment will consist of a 10-week period where participants would get access to a series of treatment modules, each addressing a separate problem area using CBT techniques. The treatment includes modules addressing depression, anxiety, panic, worry, insomnia, stress, trauma, communication skills, and relaxation. The booster program will be based on the initial treatment, but will shorter, focusing on repetition, strategies for maintenance, and coping with setbacks. The platform used is an existing platform employed by Smärtcentrum at Uppsala university hospital for delivering internet based treatments.
The study will be conducted using a randomized controlled trial with a between-group design. Participants will be randomized to two groups, were one group will gain access to iCBT treatment while the second group will be a wait-list control, and will gain access to the program once treatment of the active group is finished. Participants will assessed by a licensed psychologist, and treatment modules assigned based on their individual needs. In addition to online CBT modules, consisting of information, exercises and homework assignments, all participants will have regular contact by secure email-channel with a licensed psychologist or last-year psychology student under supervision. This contact will guide treatment, providing support, feedback on homework, and if necessary clarify treatment content and help with IT-related problems interfering with treatment adherence. After a year, participants will be invited to take part in a follow-up module, consisting of limited treatment recapitulation and evaluation.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Uppland
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Uppsala、Uppland、スウェーデン、75236
- Department of Psychology, Uppsala University
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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:
- Experienced pain for at least the three previous months
- Medically evaluated regarding the pain condition
- Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress
- Access to, and ability to use, a personal computer with internet access
- Mastery of the swedish language
Exclusion Criteria:
- Currently undergoing or planning to undergo CBT-treatment during the course of the study
- Currently undergoing or planning to undergo major changes in pharmacotherapy during the course of the study, or have made such changes in the last 2 months
- Have planned surgical intervention during the course of the study
- Currently experiencing symptoms of severe depression (scores >16 on suicidality on M.I.N.I.)
- Currently experiencing significant symptoms of psychosis (fulfills M.I.N.I criteria for psychotic syndrome, current)
- Currently experiencing significant symptoms of alcohol or substance abuse (fulfills M.I.N.I criteria for alcohol- or substance use disorder)
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:Internet-delivered therapy
10 week, guided and individually tailored internet-delivered cognitive behavioral therapy.
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介入なし:Wait list control group
Wait list control group, receives treatment at later point.
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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 in depressive symptoms
時間枠:at 10 weeks
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Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
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at 10 weeks
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Change from baseline in depressive symptoms
時間枠:at one-year
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Self reported change in depressive symptoms, Montgomery-Åsberg Depression Rating Scale (MADRS-S) Swedish version, 9 items
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at one-year
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Change from baseline in psychosocial consequences of pain
時間枠:at 10 weeks
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Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
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at 10 weeks
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Change from baseline in psychosocial consequences of pain
時間枠:at one-year
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Self reported psychosocial consequences of pain, West Haven-Yale Multidimensional Pain Inventory (WHY/MPI-S part 1), Swedish version, 22 items
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at one-year
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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 in anxiety sensitivity
時間枠:at 10 weeks
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Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
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at 10 weeks
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Change from baseline in anxiety sensitivity
時間枠:at one-year
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Self reported anxiety sensitivity, Anxiety Sensitivity Index (ASI), Swedish version, 16 items
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at one-year
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Change from baseline in symptoms of depression and anxiety
時間枠:at 10 weeks
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Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
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at 10 weeks
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Change from baseline in symptoms of depression and anxiety
時間枠:at one-year
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Self reported symptoms of depression and anxiety, Hospital Anxiety and Depression Scale (HADS), Swedish version, 14 items
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at one-year
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Change from baseline in pain disability
時間枠:at 10 weeks
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Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
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at 10 weeks
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Change from baseline in pain disability
時間枠:at one-year
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Self reported pain disability, Pain Disability Index (PDI), Swedish version, 7 items
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at one-year
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Change from baseline in quality of life
時間枠:at 10 weeks
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Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
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at 10 weeks
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Change from baseline in quality of life
時間枠:at one-year
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Self reported quality of life, Quality of Life Inventory (QOLI), Swedish version, 7 items
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at one-year
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Fear of pain due to movement
時間枠:Baseline only
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Self reported fear of movement, Tampa Scale of Kinesiophobia (TSK), Swedish version, 17 items
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Baseline only
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Change from baseline in insomnia symptoms
時間枠:at 10 weeks
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Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
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at 10 weeks
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Change from baseline in insomnia symptoms
時間枠:at one-year
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Self reported insomnia symptoms, Insomnia Severity Index (ISI), Swedish version
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at one-year
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Change from baseline in PTSD symptoms
時間枠:at 10 weeks
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Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
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at 10 weeks
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Change from baseline in PTSD symptoms
時間枠:at one-year
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Self reported PTSD symptoms, Post-Traumatic Stress Disorder checklist 5 (PCL-5), Swedish version
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at one-year
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Change from baseline in stress
時間枠:at 10 weeks
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Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
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at 10 weeks
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Change from baseline in stress
時間枠:at one-year
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Self reported stress, Shirom-Melomed Burnout Questionnaire (SMBQ), Swedish version
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at one-year
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Change from baseline in GAD-symptoms
時間枠:at 10 weeks
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Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
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at 10 weeks
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Change from baseline in GAD-symptoms
時間枠:at one-year
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Self reported GAD-symptoms , Generalized Anxiety Disorder 7 (GAD-7), Swedish version
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at one-year
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Change from baseline in pain catastrophizing
時間枠:at 5 weeks
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Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
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at 5 weeks
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Change from baseline in pain catastrophizing
時間枠:at 10 weeks
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Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
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at 10 weeks
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Change from baseline in pain catastrophizing
時間枠:at one-year
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Self reported pain catastrophizing, Pain Catastrophizing Scale (PCS), Swedish version
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at one-year
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Change from baseline in coping strategies
時間枠:at one-year
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Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
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at one-year
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Change from baseline in coping strategies
時間枠:at 5 weeks
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Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
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at 5 weeks
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Change from baseline in coping strategies
時間枠:at 10 weeks
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Self reported coping strategies , Coping Strategies Questionnaire - Revised (CSQ-R), Swedish version
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at 10 weeks
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Change from baseline in pain acceptance
時間枠:at 5 weeks
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Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
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at 5 weeks
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Change from baseline in pain acceptance
時間枠:at 10 weeks
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Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
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at 10 weeks
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Change from baseline in pain acceptance
時間枠:at one-year
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Self reported pain acceptance, Chronic Pain Acceptance Questionnaire (CPAQ), Swedish version
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at one-year
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Change from baseline in self efficacy
時間枠:at 5 weeks
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Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
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at 5 weeks
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Change from baseline in self efficacy
時間枠:at 10 weeks
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Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
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at 10 weeks
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Change from baseline in self efficacy
時間枠:at one-year
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Self reported pain related self efficacy, Pain Self Efficacy-2 (PSEQ-2), Swedish version
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at one-year
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Treatment credibility rating
時間枠:Baseline only
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Self reported treatment credibility, Treatment Credibility Scale (TCS), Swedish version
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Baseline only
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Gerhard Andersson, Professor、Linkoeping University
- スタディチェア:Torsten Gordh, Professor、Uppsala University
- スタディディレクター:Monica Buhrman, PhD、Uppsala University
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 (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
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。
慢性の痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了
Internet-Delivered Cognitive Behavioral Therapyの臨床試験
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University of Maryland, College ParkUniversity of Maryland, Baltimore; Henry Ford Health System完了物質関連障害 | オピオイド使用障害 | 治療遵守 | オピオイドの使用 | ケアの保持 | オピオイド中毒 | オピオイド投薬支援治療アメリカ
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University of Maryland, College ParkUniversity of Maryland, Baltimore; National Center for Complementary and Integrative Health...完了物質使用 | 物質使用障害 | オピオイド使用障害 | ケアの保持 | メタドン治療 | ピア配信 | オピオイド使用障害(MOUD)の投薬 | 行動活性化アメリカ