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.

Study Overview

• Status: Completed
• Conditions: Burnout Syndrome; Adjustment Disorder
• Intervention / Treatment: Behavioral: Internet-based CBT

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active treatment, 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.	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
No Intervention: Waiting list control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Alcohol Disorders Identification Test (AUDIT)	This instrument will be used for screening purpose only	Baseline
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
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
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
Client Satisfaction Questionnaire (CSQ)	Mean and standard deviations will be presented	Post-treatment (12 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Credibility Scale (C-scale)	Measures treatment credibility. Mean scores and standard deviations will be presented	Week 2 and week 8
Change in Putative mediators		week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Publications and helpful links

General Publications

• Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 13;21(9):e14675. doi: 10.2196/14675.
• Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ejeby K, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial. Psychother Psychosom. 2018;87(5):296-305. doi: 10.1159/000490742. Epub 2018 Jul 24.
• Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Stress, Psychological; Trauma and Stressor Related Disorders; Burnout, Psychological; Adjustment Disorders
• Other Study ID Numbers: ICBT for stress