Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
13 december 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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
|
|
Inget ingripande: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Perceived stress scale (PSS)
Tidsram: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in PSS at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Shirlom Melamed Burnout Questionnaire (SMBQ)
Tidsram: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in SMBQ at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Insomnia Severity Index (IS)
Tidsram: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in ISI at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Generalized AnxietyDisorder-7 (GAD-7)
Tidsram: 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)
Tidsram: 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
|
|
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
Tidsram: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in MADRS-S at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Self-rated health (SRH)
Tidsram: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
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)
Tidsram: 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)
Tidsram: 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
|
|
Brunnsviken Brief Quality of life inventory (BBQ)
Tidsram: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in BBQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
World Health Organization Disability Assessment Schedule (WHODAS)
Tidsram: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in WHODAS at post-treatment and follow-up compared to baseline.
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Alcohol Disorders Identification Test (AUDIT)
Tidsram: Baseline
|
This instrument will be used for screening purpose only
|
Baseline
|
|
Sickness questionnaire state (SQ)
Tidsram: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in SQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Tidsram: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in TIC-P at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Karolinska Sleep Questionnaire (KSQ)
Tidsram: baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in KSQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Client Satisfaction Questionnaire (CSQ)
Tidsram: Post-treatment (12 weeks)
|
Mean and standard deviations will be presented
|
Post-treatment (12 weeks)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Credibility Scale (C-scale)
Tidsram: Week 2 and week 8
|
Measures treatment credibility.
Mean scores and standard deviations will be presented
|
Week 2 and week 8
|
|
Change in Putative mediators
Tidsram: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2015
Primärt slutförande (Faktisk)
1 oktober 2017
Avslutad studie (Faktisk)
1 oktober 2017
Studieregistreringsdatum
Först inskickad
1 september 2015
Först inskickad som uppfyllde QC-kriterierna
2 september 2015
Första postat (Uppskatta)
3 september 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 december 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 december 2019
Senast verifierad
1 december 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ICBT for stress
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