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

Not Applicable

Completed

• Conditions: Burnout Syndrome; Adjustment Disorder
• Interventions: Behavioral: Internet-based CBT

• Registration Number: NCT02540317
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-03
• Study Start: 2015-10
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active treatment, Internet-based CBT	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.

Primary Outcome Measures

Name	Time	Method
Change in Perceived stress scale (PSS)	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 Outcome Measures

Name	Time	Method
Shirlom Melamed Burnout Questionnaire (SMBQ)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	Baseline	This instrument will be used for screening purpose only
Sickness questionnaire state (SQ)	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)	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)	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)	Post-treatment (12 weeks)	Mean and standard deviations will be presented