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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01667822
Other study ID # Self help CBT
Secondary ID
Status Completed
Phase Phase 3
First received August 10, 2012
Last updated October 14, 2016
Start date August 2012
Est. completion date December 2015

Study information

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

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Continued self help CBT
After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.
Individual CBT
After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.

Locations

Country Name City State
Sweden Karolinska Institutet and Gustavsberg primary care center Stockholm, Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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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