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Internet-based CBT vs. TAU for Stress-related Disorders

Primary Purpose

Adjustment Disorders, Exhaustion Disorder

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based cognitive behavior therapy
Internet-based structured treatment-as-usual
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjustment Disorders focused on measuring Internet-based treatment, Randomized controlled trial

Eligibility Criteria

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

Inclusion Criteria:

  • primary adjustment disorder or exhaustion disorder
  • regular access to a computer and to the internet
  • ability to read and write in swedish

Exclusion Criteria:

  • substance abuse in the past 6 months
  • lifetime psychosis or bipolar disorder
  • suicide risk
  • initiated or changed psychopharmacological treatment for depression or anxiety in the past month
  • concurrent psychological treatment
  • cognitive behavior therapy for stress-related symptoms in the past year.

Sites / Locations

  • Gustavsbergs Primary Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internet-based cognitive behavior therapy

Internet-based structured treatment-as-usual

Arm Description

Outcomes

Primary Outcome Measures

Perceived Stress Scale (PSS-10)
Change in PSS at post-treatment and follow-ups compared to baseline (scale range 0-40, higher score means more symptoms)

Secondary Outcome Measures

Shirom-Melamed Burnout Questionnaire (SMBQ)
Change in SMBQ at post-treatment and follow-ups compared to baseline (scale range 1-7, higher score means more symptoms)
Montgomery-Åsberg Depression Rating Scale Self-report (MADRS-S)
Change in MADRS-S at post-treatment and follow-ups compared to baseline (scale range 0-54, higher score means more symptoms)
Insomnia Severity Index (ISI)
Change in ISI at post-treatment and follow-ups compared to baseline (scale range 0-28, higher score means more symptoms)
Generalized Anxiety Disorder-7 (GAD-7)
Change in GAD-7 at post-treatment and follow-ups compared to baseline (scale range 0-21, higher score means more symptoms)
Sickness Questionnaire (SQ)
Change in SQ at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)
Self-rated Health (SRH)
Change in SRH at post-treatment and follow-ups compared to baseline (scale range 1-5, higher score means better self-rated health)
World Health Organization's Disability Assessment Scale (WHODAS 2.0)
Change in WHODAS at post-treatment and follow-ups compared to baseline (scale range 0-100, higher score means more functional disability)
EuroQol 5D (EQ5D 5L)
Change in EQ5D at post-treatment and follow-ups compared to baseline (The answers given in EQ-5D were combined to generate a utility score of health states ranging from 0 to 1, with 0 representing death and 1 representing full health) death and 1 representing full health
Trimbos and Institute Medical Technology Assessment of Costs Questionnaire for Psychiatry (TIC-P)
The TIC-P enables estimation of costs by collecting information about participant resource utilization and costs related to production loss. Change in costs will be analysed at post-treatment and follow-ups compared to baseline.
Physical Health Questionnaire (PHQ-15)
Change in PHQ-15 at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)
Cognitive impairment
Test-battery of cognitive tests measuring executive functions at post-treatment and follow-ups compared to baseline
Sick leave
Sick leave data from the Microdata for Analysis of Social Security (MiDAS) registry. Analyzed as full-day equivalents.

Full Information

First Posted
March 11, 2021
Last Updated
August 18, 2022
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT04797273
Brief Title
Internet-based CBT vs. TAU for Stress-related Disorders
Official Title
Internet-based Cognitive Behavior Therapy for Stress-related Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stress-related mental illness is common and one of the main causes of sick leave in Sweden. Cognitive behavior therapy (CBT) is a promising treatment, but access to treatment is low. In a previously conducted study, we found that internet-based CBT in comparison to a waitlist control group was effective in reducing symptoms of stress. The aim of the present study is to take the next step and compare Internet-based CBT for stress-related disorders to an active control condition.
Detailed Description
Non traumatic stress-related mental illness, in this study operationalized as adjustment disorder or exhaustion disorder, is highly prevalent in the general population and associated with high societal costs relating to productivity loss. Cognitive behavior therapy (CBT) is the most well-studied psychological treatment and has demonstrated promising effects in terms of symptom reduction. The overall evidence-base for CBT for these disorders is however fairly week and access to treatment is low. In a previously published randomized controlled trial we found that internet-based CBT can yield large effects on core symptoms of stress for these disorders. Delivering CBT via the internet has the large advantage of enabling increased accessibility as each therapist can have up to 80 patients in ongoing treatment. In the previously conducted trial we compared the treatment to a waitlist control and between-group comparisons of treatment effects were only done at post-treatment as the waitlist condition was crossed over to treatment after this time point. It is now therefore important to take the next step and investigate the effects of internet-based CBT in comparison to an active control condition. The primary aim of this study was to compare two internet-based treatments, CBT vs. structured treatment-as-usual, for adjustment disorder and exhaustion disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjustment Disorders, Exhaustion Disorder
Keywords
Internet-based treatment, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based cognitive behavior therapy
Arm Type
Experimental
Arm Title
Internet-based structured treatment-as-usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Internet-based cognitive behavior therapy
Intervention Description
12 week Internet-based cognitive behavior therapy, delivered via an online treatment platform. The treatment includes components such as exercises in conducting recuperating activities, methods to improve sleep, exposure, and behavioral activation. The treatment content is provided through written texts, images and audiofiles in the treatment platform. The participant has access to a therapist who provides support throughout the treatment via asynchronous text messages.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based structured treatment-as-usual
Intervention Description
This is a 12-week treatment, delivered via an online treatment platform. The treatment components in this treatment are designed to be similar to what is typically provided in primary care to these patients and includes information about stress and how different factors such as eating habits, physical exercise, and alcohol can contribute to stress problems. The treatment content is provided through written texts, images and audiofiles in the treatment platform. The participant has access to a therapist who provides support throughout the treatment via asynchronous text messages.
Primary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10)
Description
Change in PSS at post-treatment and follow-ups compared to baseline (scale range 0-40, higher score means more symptoms)
Time Frame
Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
Secondary Outcome Measure Information:
Title
Shirom-Melamed Burnout Questionnaire (SMBQ)
Description
Change in SMBQ at post-treatment and follow-ups compared to baseline (scale range 1-7, higher score means more symptoms)
Time Frame
Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Montgomery-Åsberg Depression Rating Scale Self-report (MADRS-S)
Description
Change in MADRS-S at post-treatment and follow-ups compared to baseline (scale range 0-54, higher score means more symptoms)
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Insomnia Severity Index (ISI)
Description
Change in ISI at post-treatment and follow-ups compared to baseline (scale range 0-28, higher score means more symptoms)
Time Frame
Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
Change in GAD-7 at post-treatment and follow-ups compared to baseline (scale range 0-21, higher score means more symptoms)
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Sickness Questionnaire (SQ)
Description
Change in SQ at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Self-rated Health (SRH)
Description
Change in SRH at post-treatment and follow-ups compared to baseline (scale range 1-5, higher score means better self-rated health)
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
World Health Organization's Disability Assessment Scale (WHODAS 2.0)
Description
Change in WHODAS at post-treatment and follow-ups compared to baseline (scale range 0-100, higher score means more functional disability)
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
EuroQol 5D (EQ5D 5L)
Description
Change in EQ5D at post-treatment and follow-ups compared to baseline (The answers given in EQ-5D were combined to generate a utility score of health states ranging from 0 to 1, with 0 representing death and 1 representing full health) death and 1 representing full health
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Trimbos and Institute Medical Technology Assessment of Costs Questionnaire for Psychiatry (TIC-P)
Description
The TIC-P enables estimation of costs by collecting information about participant resource utilization and costs related to production loss. Change in costs will be analysed at post-treatment and follow-ups compared to baseline.
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Physical Health Questionnaire (PHQ-15)
Description
Change in PHQ-15 at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Cognitive impairment
Description
Test-battery of cognitive tests measuring executive functions at post-treatment and follow-ups compared to baseline
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Sick leave
Description
Sick leave data from the Microdata for Analysis of Social Security (MiDAS) registry. Analyzed as full-day equivalents.
Time Frame
1 year prior to baseline up to 2 years after baseline.
Other Pre-specified Outcome Measures:
Title
Karolinska Exhaustion Disorder Scale (KEDS)
Description
Exploratory assessment of change at post-treatment and follow-ups compared to baseline (scale range 0-54, higher score means more symptoms)
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Negative Events Questionnaire, 20-items (NEQ-20)
Description
Post-treatment only report of negative events from treatment (scale range 0-80, higher score indicates more negative events)
Time Frame
week 12 (Post-treatment)
Title
Credibility scale (C-scale)
Description
week 3 only report of treatment credibility (scale range 0-50, higher score means higher credibility)
Time Frame
week 3
Title
The Corona Virus Health Impact Survey -Short (CRISIS short)
Description
Exploratory analysis of the impact of the Corona virus on worry and life style. Change in sum score of items 1,2,3,4,5,8 and 9 will be analyzed. Scale range 0-24. Higher scores mean higher impact of Corona.
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Subjective memory
Description
Exploratory analysis of change in subjective memory at post-treatment and follow-ups compared to baseline (scale range 0-26, higher score means more subjective problems with memory)
Time Frame
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Title
Recovery Experience Questionnaire short version
Description
Will be analyzed as potential mediator of treatment change. 7 items, scored 0-4. Scale-range 0-28. Higher scores indicate more recovery.
Time Frame
Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

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: primary adjustment disorder or exhaustion disorder regular access to a computer and to the internet ability to read and write in swedish Exclusion Criteria: substance abuse in the past 6 months lifetime psychosis or bipolar disorder suicide risk initiated or changed psychopharmacological treatment for depression or anxiety in the past month concurrent psychological treatment cognitive behavior therapy for stress-related symptoms in the past year.
Facility Information:
Facility Name
Gustavsbergs Primary Care Center
City
Gustavsberg
State/Province
Stockholm
ZIP/Postal Code
13440
Country
Sweden

12. IPD Sharing Statement

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Internet-based CBT vs. TAU for Stress-related Disorders

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