Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01667822
First received: August 10, 2012
Last updated: October 8, 2014
Last verified: October 2014

August 10, 2012
October 8, 2014
August 2012
December 2014   (final data collection date for primary outcome measure)
Clinician Severity Rating (CSR) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.
Same as current
Complete list of historical versions of study NCT01667822 on ClinicalTrials.gov Archive Site
  • Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up
  • Work ability index (WAI) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up
  • Insomnia Severity Index (ISI) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up
  • Health Anxiety Inventory (HAI) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
  • Perceived Stress Scale (PSS) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up
  • 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 ] [ Designated as safety issue: No ]
    Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
  • Quality of Life Inventory (QOLI) [ Time Frame: Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
  • EuroQol-5 dimension (EQ5D) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
  • Sheehan Disability Scales (SDS) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
  • Self-rated health 5 (SRH-5) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up
  • Obsessive Compulsive Inventory-Revised (OCI-R) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
  • Liebowitz Social Anxiety Scale Self-report (LSAS-SR) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
  • Panic Disorder Severity Scale Self-rated (PDSS-SR) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
  • Penn-State Worry Questionnaire (PSWQ) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Same as current
Not Provided
Not Provided
 
Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
Not Provided

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety Disorders
  • Major Depression
  • Stress Disorders
  • Primary Insomnia
  • 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.
  • Behavioral: 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.
  • Active Comparator: Continued guided self help CBT
    Continued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total).
    Intervention: Behavioral: Continued self help CBT
  • Experimental: CBT individual therapy
    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.
    Intervention: Behavioral: Individual CBT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01667822
Self help CBT
No
Erik Hedman, Karolinska Institutet
Karolinska Institutet
Stockholm County Council, Sweden
Not Provided
Karolinska Institutet
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP