Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

Study Overview
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Brief Summary
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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).

Conditions
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Anxiety Disorders, Major Depression, Stress Disorders, Primary Insomnia

Intervention / Treatment
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* Behavioral: Continued self help CBT
* Behavioral: Individual CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continued guided self help CBT<br>Continued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total). | Behavioral: Continued self help CBT<br>* After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.<br>|
| Experimental: CBT individual therapy<br>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. | Behavioral: Individual CBT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |