Clinical trial NCT01667822: Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Major Depression
Stress Disorders
Primary Insomnia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2012-08-17
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
timeFrame: 9 weeks
measure: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
timeFrame: 20 weeks
measure: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
timeFrame: 26 weeks
measure: Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
timeFrame: 52 weeks
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Work ability index (WAI)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Health Anxiety Inventory (HAI)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Quality of Life Inventory (QOLI)
timeFrame: Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up
measure: EuroQol-5 dimension (EQ5D)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Sheehan Disability Scales (SDS)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Self-rated health 5 (SRH-5)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Obsessive Compulsive Inventory-Revised (OCI-R)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Liebowitz Social Anxiety Scale Self-report (LSAS-SR)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Panic Disorder Severity Scale Self-rated (PDSS-SR)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
measure: Penn-State Worry Questionnaire (PSWQ)
timeFrame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Other outcomes:
measure: Inflammatory cytokines
timeFrame: Baseline, post-treatment (20 weeks)
Locations:
city: Stockholm,
country: Sweden
facility: Karolinska Institutet and Gustavsberg primary care center
state: Stockholm
Study officials:
References: