Clinical trial NCT02540317: Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adjustment Disorder
Burnout Syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Perceived stress scale (PSS)
timeFrame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Secondary outcomes:
measure: Shirlom Melamed Burnout Questionnaire (SMBQ)
timeFrame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
measure: Insomnia Severity Index (IS)
timeFrame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
measure: Generalized AnxietyDisorder-7 (GAD-7)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Physical Health Questionnaire-15 (PHQ-15)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Self-rated health (SRH)
timeFrame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
measure: Work Ability Index (WAI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Euroqol 5 dimensions (EQ5D)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Brunnsviken Brief Quality of life inventory (BBQ)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: World Health Organization Disability Assessment Schedule (WHODAS)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Alcohol Disorders Identification Test (AUDIT)
timeFrame: Baseline
measure: Sickness questionnaire state (SQ)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Karolinska Sleep Questionnaire (KSQ)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-treatment (12 weeks)
Other outcomes:
measure: Credibility Scale (C-scale)
timeFrame: Week 2 and week 8
measure: Change in Putative mediators
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.