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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title:

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 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. 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.
Sponsor: Karolinska Institutet

Current Primary Outcome: 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


Original Primary Outcome: Change in Perceived stress scale (PSS) [ Time Frame: baseline, up to post-treatment (12 weeks), 6 month follow-up ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Shirlom Melamed Burnout Questionnaire (SMBQ) [ Time Frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up ]
    Change in SMBQ at post-treatment and follow-up compared to baseline
  • Insomnia Severity Index (IS) [ Time Frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up ]
    Change in ISI at post-treatment and follow-up compared to baseline
  • Generalized AnxietyDisorder-7 (GAD-7) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in GAD-7 at post-treatment and follow-up compared to baseline
  • Physical Health Questionnaire-15 (PHQ-15) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in PHQ-15 at post-treatment and follow-up compared to baseline
  • Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in MADRS-S at post-treatment and follow-up compared to baseline
  • Self-rated health (SRH) [ Time Frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up ]
    Change in SRH at post-treatment and follow-up compared to baseline
  • Work Ability Index (WAI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in WAI at post-treatment and follow-up compared to baseline
  • Euroqol 5 dimensions (EQ5D) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in EQ5D at post-treatment and follow-up compared to baseline
  • Brunnsviken Brief Quality of life inventory (BBQ) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in BBQ at post-treatment and follow-up compared to baseline
  • World Health Organization Disability Assessment Schedule (WHODAS) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in WHODAS at post-treatment and follow-up compared to baseline. This instrument will be used if a Swedish translation is availible at the time of start of recruitment, not otherwise.
  • Alcohol Disorders Identification Test (AUDIT) [ Time Frame: Baseline ]
    This instrument will be used for screening purpose only
  • Sickness questionnaire state (SQ) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change 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) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in TIC-P at post-treatment and follow-up compared to baseline
  • Karolinska Sleep Questionnaire (KSQ) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up ]
    Change in KSQ at post-treatment and follow-up compared to baseline
  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Post-treatment (12 weeks) ]
    Mean and standard deviations will be presented


Information By: Karolinska Institutet

Dates:
Date Received: September 1, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: February 7, 2017
Last Verified: February 2017