An interventional study of Internet-based CBT in Adjustment Disorder and Burnout Syndrome, sponsored by Karolinska Institutet. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 52 interventional studies indexed under Adjustment Disorders.
Browse Adjustment Disorders studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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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.
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
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.
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
Change in Perceived stress scale (PSS)
Change in PSS at post-treatment and follow-up compared to baseline
Time frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Shirlom Melamed Burnout Questionnaire (SMBQ)
Change in SMBQ at post-treatment and follow-up compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Alcohol Disorders Identification Test (AUDIT)
This instrument will be used for screening purpose only
Time frame: Baseline
Sickness questionnaire state (SQ)
Change in SQ at post-treatment and follow-up compared to baseline
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)
Change in TIC-P at post-treatment and follow-up compared to baseline
Time frame: 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
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Client Satisfaction Questionnaire (CSQ)
Mean and standard deviations will be presented
Time frame: Post-treatment (12 weeks)
Credibility Scale (C-scale)
Measures treatment credibility. Mean scores and standard deviations will be presented
Time frame: Week 2 and week 8
Change in Putative mediators
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
No study locations are listed for this record.
The record gives a start of Oct 2015, a primary completion of Oct 2017 and a completion of Oct 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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