Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- Karolinska Institutet
- Enrollment
- 396
- Locations
- 1
- Primary Endpoint
- Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Investigators
Erik Hedman
Principal investigator
Karolinska Institutet
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
Outcomes
Primary Outcomes
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Time Frame: 52 weeks
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Secondary Outcomes
- EuroQol-5 dimension (EQ5D)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Self-rated health 5 (SRH-5)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Obsessive Compulsive Inventory-Revised (OCI-R)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Panic Disorder Severity Scale Self-rated (PDSS-SR)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Health Anxiety Inventory (HAI)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Quality of Life Inventory (QOLI)(Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up)
- Sheehan Disability Scales (SDS)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Liebowitz Social Anxiety Scale Self-report (LSAS-SR)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Penn-State Worry Questionnaire (PSWQ)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Work ability index (WAI)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Insomnia Severity Index (ISI)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Perceived Stress Scale (PSS)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)
- Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)(Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up)