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

NCT02540317 | Completed

• 1 other identifier: ICBT for stress
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adjustment Disorder; Burnout Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Shirlom Melamed Burnout Questionnaire (SMBQ)

  baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up

• Insomnia Severity Index (IS)

  baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up

• Generalized AnxietyDisorder-7 (GAD-7)

  baseline, post-treatment (12 weeks), 6 month follow-up

• Physical Health Questionnaire-15 (PHQ-15)

  baseline, post-treatment (12 weeks), 6 month follow-up

• Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)

  baseline, post-treatment (12 weeks), 6 month follow-up

Other Outcomes (2)

• Credibility Scale (C-scale)

  Week 2 and week 8

• Change in Putative mediators

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

Study Arms (2)

Active treatment, Internet-based CBT

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.

Behavioral: Internet-based CBT

Waiting list control

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.

Interventions

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

Active treatment, Internet-based CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (3)

• 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.

  PMID: 31586370 DERIVED

• 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.

  PMID: 30041167 DERIVED

• 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.

  PMID: 29222080 DERIVED

MeSH Terms

Conditions

Adjustment Disorders; Burnout, Psychological

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Associate professor, phd

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 16, 2019

Record last verified: 2019-12