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

Burnout Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540317
• Other study ID #: ICBT for stress
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: December 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjustment Disorder
• Adjustment Disorders
• Burnout Syndrome
• Burnout, Psychological

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Credibility Scale (C-scale)	Measures treatment credibility. Mean scores and standard deviations will be presented	Week 2 and week 8
Other	Change in Putative mediators		week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Primary	Change in Perceived stress scale (PSS)	Change in PSS at post-treatment and follow-up compared to baseline	baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Secondary	Shirlom Melamed Burnout Questionnaire (SMBQ)	Change in SMBQ at post-treatment and follow-up compared to baseline	baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Secondary	Insomnia Severity Index (IS)	Change in ISI at post-treatment and follow-up compared to baseline	baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Secondary	Generalized AnxietyDisorder-7 (GAD-7)	Change in GAD-7 at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Physical Health Questionnaire-15 (PHQ-15)	Change in PHQ-15 at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)	Change in MADRS-S at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Self-rated health (SRH)	Change in SRH at post-treatment and follow-up compared to baseline	baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Secondary	Work Ability Index (WAI)	Change in WAI at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Euroqol 5 dimensions (EQ5D)	Change in EQ5D at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Brunnsviken Brief Quality of life inventory (BBQ)	Change in BBQ at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	World Health Organization Disability Assessment Schedule (WHODAS)	Change in WHODAS at post-treatment and follow-up compared to baseline.	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Alcohol Disorders Identification Test (AUDIT)	This instrument will be used for screening purpose only	Baseline
Secondary	Sickness questionnaire state (SQ)	Change in SQ at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	Change in TIC-P at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Karolinska Sleep Questionnaire (KSQ)	Change in KSQ at post-treatment and follow-up compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up
Secondary	Client Satisfaction Questionnaire (CSQ)	Mean and standard deviations will be presented	Post-treatment (12 weeks)