Anxiety Disorders Clinical Trial
Verified date | October 2016 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: The National Board of Health and Welfare |
Study type | Interventional |
Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily
from mental health disorders, such as anxiety disorders and depression. Cognitive behavior
therapy (CBT) has been shown to be an effective treatment of these disorders. Despite the
strong evidence for CBT there is a lack of evidence-based psychological treatment in primary
care. For various reasons, the progress of research has not affected clinical practice. For
successful implementation of CBT in primary care cost-effective therapies, access to
therapists with proper training and supervision, evidence-based manuals and management that
support the implementation is needed.
Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All
patients are first treated with self-help CBT (N = 400). Patients that do not improve after
treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based
on published studies 2/3 is expected to be improved after self-help and therefore do not
undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to
individual CBT (N = 67) or continued self-help treatment (N = 67).
Status | Completed |
Enrollment | 396 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia Clinician severity rating scale 2-6 Exclusion Criteria: - A higher score than 6 on the Clinician severity rating scale |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet and Gustavsberg primary care center | Stockholm, | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Stockholm County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Inflammatory cytokines | Change in inflammatory cytokines at post-treatment | Baseline, post-treatment (20 weeks) | |
Primary | Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population | Absolute improvement, i.e., symptom level below pre-established cut-offs at 9 weeks, 20 weeks, 26 week follow-up, and 52 week follow-up compared to baseline. | 9 weeks | No |
Primary | Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population | Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population | 20 weeks | No |
Primary | Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population | Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population | 26 weeks | No |
Primary | Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population | Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population | 52 weeks | No |
Secondary | Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S) | Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Work ability index (WAI) | Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Insomnia Severity Index (ISI) | Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Health Anxiety Inventory (HAI) | Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Perceived Stress Scale (PSS) | Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) | Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Quality of Life Inventory (QOLI) | Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up | Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up | No |
Secondary | EuroQol-5 dimension (EQ5D) | Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Sheehan Disability Scales (SDS) | Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Self-rated health 5 (SRH-5) | Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Obsessive Compulsive Inventory-Revised (OCI-R) | Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific. | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Liebowitz Social Anxiety Scale Self-report (LSAS-SR) | Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific. | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Panic Disorder Severity Scale Self-rated (PDSS-SR) | Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific. | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
Secondary | Penn-State Worry Questionnaire (PSWQ) | Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific. | Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up | No |
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