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Completed

NCT Number: NCT01667822

Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

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).

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Key information

Conditions

Anxiety Disorders Depressive Disorder Depressive Disorder, Major Dyssomnias Major Depression Mental Disorders Mood Disorders Nervous System Diseases Primary Insomnia Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Karolinska Institutet and Gustavsberg primary care center

Stockholm, Stockholm County, 13440, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continued self help CBT

Behavioral

After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.

individual CBT

Behavioral

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.

Primary outcomes

  1. Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population

    Time frame: 9 weeks

    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.

  2. Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population

    Time frame: 20 weeks

    Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population

  3. Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population

    Time frame: 26 weeks

    Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population

  4. 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

  1. Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up

  2. Work ability index (WAI)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up

  3. Insomnia Severity Index (ISI)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up

  4. Health Anxiety Inventory (HAI)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up

  5. Perceived Stress Scale (PSS)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up

  6. Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up

  7. Quality of Life Inventory (QOLI)

    Time frame: Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up

    Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up

  8. EuroQol-5 dimension (EQ5D)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up

  9. Sheehan Disability Scales (SDS)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up

  10. Self-rated health 5 (SRH-5)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up

  11. Obsessive Compulsive Inventory-Revised (OCI-R)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  12. Liebowitz Social Anxiety Scale Self-report (LSAS-SR)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  13. Panic Disorder Severity Scale Self-rated (PDSS-SR)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  14. Penn-State Worry Questionnaire (PSWQ)

    Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

    Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

Other outcomes

  1. Inflammatory cytokines

    Time frame: Baseline, post-treatment (20 weeks)

    Change in inflammatory cytokines at post-treatment

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 17, 2012
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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