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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT02540317
Collaborator
(none)
100
2
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet-based CBT
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Perceived stress scale (PSS) [baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up]

    Change in PSS at post-treatment and follow-up compared to baseline

Secondary Outcome Measures

  1. Shirlom Melamed Burnout Questionnaire (SMBQ) [baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up]

    Change in SMBQ at post-treatment and follow-up compared to baseline

  2. Insomnia Severity Index (IS) [baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up]

    Change in ISI at post-treatment and follow-up compared to baseline

  3. Generalized AnxietyDisorder-7 (GAD-7) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in GAD-7 at post-treatment and follow-up compared to baseline

  4. Physical Health Questionnaire-15 (PHQ-15) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in PHQ-15 at post-treatment and follow-up compared to baseline

  5. Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in MADRS-S at post-treatment and follow-up compared to baseline

  6. Self-rated health (SRH) [baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up]

    Change in SRH at post-treatment and follow-up compared to baseline

  7. Work Ability Index (WAI) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in WAI at post-treatment and follow-up compared to baseline

  8. Euroqol 5 dimensions (EQ5D) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in EQ5D at post-treatment and follow-up compared to baseline

  9. Brunnsviken Brief Quality of life inventory (BBQ) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in BBQ at post-treatment and follow-up compared to baseline

  10. World Health Organization Disability Assessment Schedule (WHODAS) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in WHODAS at post-treatment and follow-up compared to baseline.

  11. Alcohol Disorders Identification Test (AUDIT) [Baseline]

    This instrument will be used for screening purpose only

  12. Sickness questionnaire state (SQ) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in SQ at post-treatment and follow-up compared to baseline

  13. Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in TIC-P at post-treatment and follow-up compared to baseline

  14. Karolinska Sleep Questionnaire (KSQ) [baseline, post-treatment (12 weeks), 6 month follow-up]

    Change in KSQ at post-treatment and follow-up compared to baseline

  15. Client Satisfaction Questionnaire (CSQ) [Post-treatment (12 weeks)]

    Mean and standard deviations will be presented

Other Outcome Measures

  1. Credibility Scale (C-scale) [Week 2 and week 8]

    Measures treatment credibility. Mean scores and standard deviations will be presented

  2. Change in Putative mediators [week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erik Hedman, Principal investigator, Associate professor, phd, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02540317
Other Study ID Numbers:
  • ICBT for stress
First Posted:
Sep 3, 2015
Last Update Posted:
Dec 16, 2019
Last Verified:
Dec 1, 2019
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2019