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

Primary Purpose

Adjustment Disorder, Burnout Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-based CBT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjustment Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Active treatment, Internet-based CBT

    Waiting list control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in Perceived stress scale (PSS)
    Change in PSS at post-treatment and follow-up compared to baseline

    Secondary Outcome Measures

    Shirlom Melamed Burnout Questionnaire (SMBQ)
    Change in SMBQ at post-treatment and follow-up compared to baseline
    Insomnia Severity Index (IS)
    Change in ISI at post-treatment and follow-up compared to baseline
    Generalized AnxietyDisorder-7 (GAD-7)
    Change in GAD-7 at post-treatment and follow-up compared to baseline
    Physical Health Questionnaire-15 (PHQ-15)
    Change in PHQ-15 at post-treatment and follow-up compared to baseline
    Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
    Change in MADRS-S at post-treatment and follow-up compared to baseline
    Self-rated health (SRH)
    Change in SRH at post-treatment and follow-up compared to baseline
    Work Ability Index (WAI)
    Change in WAI at post-treatment and follow-up compared to baseline
    Euroqol 5 dimensions (EQ5D)
    Change in EQ5D at post-treatment and follow-up compared to baseline
    Brunnsviken Brief Quality of life inventory (BBQ)
    Change in BBQ at post-treatment and follow-up compared to baseline
    World Health Organization Disability Assessment Schedule (WHODAS)
    Change in WHODAS at post-treatment and follow-up compared to baseline.
    Alcohol Disorders Identification Test (AUDIT)
    This instrument will be used for screening purpose only
    Sickness questionnaire state (SQ)
    Change in SQ at post-treatment and follow-up compared to baseline
    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
    Karolinska Sleep Questionnaire (KSQ)
    Change in KSQ at post-treatment and follow-up compared to baseline
    Client Satisfaction Questionnaire (CSQ)
    Mean and standard deviations will be presented

    Full Information

    First Posted
    September 1, 2015
    Last Updated
    December 13, 2019
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02540317
    Brief Title
    Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    October 1, 2017 (Actual)
    Study Completion Date
    October 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adjustment Disorder, Burnout Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active treatment, Internet-based CBT
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Waiting list control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet-based CBT
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in Perceived stress scale (PSS)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Shirlom Melamed Burnout Questionnaire (SMBQ)
    Description
    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
    Title
    Insomnia Severity Index (IS)
    Description
    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
    Title
    Generalized AnxietyDisorder-7 (GAD-7)
    Description
    Change in GAD-7 at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Physical Health Questionnaire-15 (PHQ-15)
    Description
    Change in PHQ-15 at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
    Description
    Change in MADRS-S at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Self-rated health (SRH)
    Description
    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
    Title
    Work Ability Index (WAI)
    Description
    Change in WAI at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Euroqol 5 dimensions (EQ5D)
    Description
    Change in EQ5D at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Brunnsviken Brief Quality of life inventory (BBQ)
    Description
    Change in BBQ at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    World Health Organization Disability Assessment Schedule (WHODAS)
    Description
    Change in WHODAS at post-treatment and follow-up compared to baseline.
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Alcohol Disorders Identification Test (AUDIT)
    Description
    This instrument will be used for screening purpose only
    Time Frame
    Baseline
    Title
    Sickness questionnaire state (SQ)
    Description
    Change in SQ at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
    Description
    Change in TIC-P at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Karolinska Sleep Questionnaire (KSQ)
    Description
    Change in KSQ at post-treatment and follow-up compared to baseline
    Time Frame
    baseline, post-treatment (12 weeks), 6 month follow-up
    Title
    Client Satisfaction Questionnaire (CSQ)
    Description
    Mean and standard deviations will be presented
    Time Frame
    Post-treatment (12 weeks)
    Other Pre-specified Outcome Measures:
    Title
    Credibility Scale (C-scale)
    Description
    Measures treatment credibility. Mean scores and standard deviations will be presented
    Time Frame
    Week 2 and week 8
    Title
    Change in Putative mediators
    Time Frame
    week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31586370
    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.
    Results Reference
    derived
    PubMed Identifier
    30041167
    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.
    Results Reference
    derived
    PubMed Identifier
    29222080
    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.
    Results Reference
    derived

    Learn more about this trial

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

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