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Completed

NCT Number: NCT02540317

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

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.

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Key information

Conditions

Adjustment Disorder Adjustment Disorders Behavior Behavioral Symptoms Burnout Syndrome Burnout, Psychological Mental Disorders Stress, Psychological Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet-based CBT

Behavioral

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. Alcohol Disorders Identification Test (AUDIT)

    Time frame: Baseline

    This instrument will be used for screening purpose only

  12. 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

  13. 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

  14. 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

  15. Client Satisfaction Questionnaire (CSQ)

    Time frame: Post-treatment (12 weeks)

    Mean and standard deviations will be presented

Other outcomes

  1. Credibility Scale (C-scale)

    Time frame: Week 2 and week 8

    Measures treatment credibility. Mean scores and standard deviations will be presented

  2. Change in Putative mediators

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 3, 2015
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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