Overview

This trial is active, not recruiting.

Conditions adjustment disorder, burnout syndrome
Treatment internet-based cbt
Sponsor Karolinska Institutet
Start date October 2015
End date October 2016
Trial size 100 participants
Trial identifier NCT02540317, ICBT for stress

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Primary purpose treatment
Arm
(Experimental)
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.
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
(No Intervention)
The control condition is a waiting list. Participants in this arm receive no active treatment. After 12 weeks on waiting list, participants are crossed over to treatment.

Primary Outcomes

Measure
Change in Perceived stress scale (PSS)
time frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.