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Clinical Trials/NCT02540317
NCT02540317
Completed
N/A

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

Karolinska Institutet0 sites100 target enrollmentOctober 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adjustment Disorder
Sponsor
Karolinska Institutet
Enrollment
100
Primary Endpoint
Change in Perceived stress scale (PSS)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
October 1, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erik Hedman

Principal investigator, Associate professor, phd

Karolinska Institutet

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Perceived stress scale (PSS)

Time Frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up

Change in PSS at post-treatment and follow-up compared to baseline

Secondary Outcomes

  • Shirlom Melamed Burnout Questionnaire (SMBQ)(baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up)
  • Insomnia Severity Index (IS)(baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up)
  • Generalized AnxietyDisorder-7 (GAD-7)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • Physical Health Questionnaire-15 (PHQ-15)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • Self-rated health (SRH)(baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up)
  • Work Ability Index (WAI)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • Euroqol 5 dimensions (EQ5D)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • Brunnsviken Brief Quality of life inventory (BBQ)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • World Health Organization Disability Assessment Schedule (WHODAS)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • Alcohol Disorders Identification Test (AUDIT)(Baseline)
  • Sickness questionnaire state (SQ)(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)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • Karolinska Sleep Questionnaire (KSQ)(baseline, post-treatment (12 weeks), 6 month follow-up)
  • Client Satisfaction Questionnaire (CSQ)(Post-treatment (12 weeks))

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