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Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02540317
Enrollment
100
Registered
2015-09-03
Start date
2015-10-31
Completion date
2017-10-01
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjustment Disorder, Burnout Syndrome

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Perceived stress scale (PSS)baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-upChange in PSS at post-treatment and follow-up compared to baseline

Secondary

MeasureTime frameDescription
Brunnsviken Brief Quality of life inventory (BBQ)baseline, post-treatment (12 weeks), 6 month follow-upChange in BBQ at post-treatment and follow-up compared to baseline
Shirlom Melamed Burnout Questionnaire (SMBQ)baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-upChange in SMBQ at post-treatment and follow-up compared to baseline
Insomnia Severity Index (IS)baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-upChange in ISI at post-treatment and follow-up compared to baseline
Generalized AnxietyDisorder-7 (GAD-7)baseline, post-treatment (12 weeks), 6 month follow-upChange in GAD-7 at post-treatment and follow-up compared to baseline
Physical Health Questionnaire-15 (PHQ-15)baseline, post-treatment (12 weeks), 6 month follow-upChange in PHQ-15 at post-treatment and follow-up compared to baseline
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)baseline, post-treatment (12 weeks), 6 month follow-upChange in MADRS-S at post-treatment and follow-up compared to baseline
Self-rated health (SRH)baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-upChange in SRH at post-treatment and follow-up compared to baseline
Work Ability Index (WAI)baseline, post-treatment (12 weeks), 6 month follow-upChange in WAI at post-treatment and follow-up compared to baseline
Karolinska Sleep Questionnaire (KSQ)baseline, post-treatment (12 weeks), 6 month follow-upChange in KSQ at post-treatment and follow-up compared to baseline
Client Satisfaction Questionnaire (CSQ)Post-treatment (12 weeks)Mean and standard deviations will be presented
Euroqol 5 dimensions (EQ5D)baseline, post-treatment (12 weeks), 6 month follow-upChange in EQ5D at post-treatment and follow-up compared to baseline
World Health Organization Disability Assessment Schedule (WHODAS)baseline, post-treatment (12 weeks), 6 month follow-upChange in WHODAS at post-treatment and follow-up compared to baseline.
Alcohol Disorders Identification Test (AUDIT)BaselineThis instrument will be used for screening purpose only
Sickness questionnaire state (SQ)baseline, post-treatment (12 weeks), 6 month follow-upChange in SQ at post-treatment and follow-up compared to baseline
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)baseline, post-treatment (12 weeks), 6 month follow-upChange in TIC-P at post-treatment and follow-up compared to baseline

Other

MeasureTime frameDescription
Credibility Scale (C-scale)Week 2 and week 8Measures treatment credibility. Mean scores and standard deviations will be presented
Change in Putative mediatorsweek 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026