Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
13 décembre 2019 mis à jour par: Erik Hedman, Karolinska Institutet
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering.
Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited.
One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression.
In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100).
Participants will be randomized to active treatment (n=50) or a control condition on waiting list.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering.
Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited.
One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression.
Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system.
In this study psychologists will deliver the treatment.
We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100).
Participants will be randomized to active treatment (n=50) or a control condition on waiting list.
We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.
Type d'étude
Interventionnel
Inscription (Réel)
100
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.
Exclusion Criteria:
Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Active treatment, Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system.
The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long.
The treatment is based on cognitive behavior therapy.
Participants will be stratified based on diagnosis, i.e. adjustment disorder and burnout.
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Internet-based treatment with therapist support using an asynchronous messaging system.
The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long.
The treatment is based on cognitive behavior therapy
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Aucune intervention: Waiting list control
The control condition is a waiting list.
Participants in this arm receive no active treatment.
After 12 weeks on waiting list, participants are crossed over to treatment.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Perceived stress scale (PSS)
Délai: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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Change in PSS at post-treatment and follow-up compared to baseline
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baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Shirlom Melamed Burnout Questionnaire (SMBQ)
Délai: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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Change in SMBQ at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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|
Insomnia Severity Index (IS)
Délai: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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Change in ISI at post-treatment and follow-up compared to baseline
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baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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Generalized AnxietyDisorder-7 (GAD-7)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in GAD-7 at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Physical Health Questionnaire-15 (PHQ-15)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in PHQ-15 at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
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Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
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Change in MADRS-S at post-treatment and follow-up compared to baseline
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baseline, post-treatment (12 weeks), 6 month follow-up
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Self-rated health (SRH)
Délai: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
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Change in SRH at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Work Ability Index (WAI)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in WAI at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Euroqol 5 dimensions (EQ5D)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in EQ5D at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
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Brunnsviken Brief Quality of life inventory (BBQ)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
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Change in BBQ at post-treatment and follow-up compared to baseline
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baseline, post-treatment (12 weeks), 6 month follow-up
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World Health Organization Disability Assessment Schedule (WHODAS)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
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Change in WHODAS at post-treatment and follow-up compared to baseline.
|
baseline, post-treatment (12 weeks), 6 month follow-up
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Alcohol Disorders Identification Test (AUDIT)
Délai: Baseline
|
This instrument will be used for screening purpose only
|
Baseline
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Sickness questionnaire state (SQ)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
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Change in SQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
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Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
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Change in TIC-P at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
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Karolinska Sleep Questionnaire (KSQ)
Délai: baseline, post-treatment (12 weeks), 6 month follow-up
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Change in KSQ at post-treatment and follow-up compared to baseline
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baseline, post-treatment (12 weeks), 6 month follow-up
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Client Satisfaction Questionnaire (CSQ)
Délai: Post-treatment (12 weeks)
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Mean and standard deviations will be presented
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Post-treatment (12 weeks)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Credibility Scale (C-scale)
Délai: Week 2 and week 8
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Measures treatment credibility.
Mean scores and standard deviations will be presented
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Week 2 and week 8
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Change in Putative mediators
Délai: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 13;21(9):e14675. doi: 10.2196/14675.
- Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ejeby K, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial. Psychother Psychosom. 2018;87(5):296-305. doi: 10.1159/000490742. Epub 2018 Jul 24.
- Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2015
Achèvement primaire (Réel)
1 octobre 2017
Achèvement de l'étude (Réel)
1 octobre 2017
Dates d'inscription aux études
Première soumission
1 septembre 2015
Première soumission répondant aux critères de contrôle qualité
2 septembre 2015
Première publication (Estimation)
3 septembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 décembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 décembre 2019
Dernière vérification
1 décembre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ICBT for stress
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