Anxiety DisordersPhase 3NCT01667822
Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
A Phase 3 study testing Continued self help CBT and Individual CBT in people with Anxiety Disorders and Major Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders, Major Depression, Stress Disorders
- What is being tested?
- Continued self help CBT and Individual CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2012to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A higher score than 6 on the Clinician severity rating scale
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet and Gustavsberg primary care center
Stockholm, Stockholm County, 13440
About this study
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).
- Being tested
- Continued self help CBT, Individual CBT
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Major, Stress Disorders, Traumatic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continued self help CBTBehavioural
After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.
Individual CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Continued guided self help CBT | Active comparator | Continued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total). Receives: Behavioral: Continued self help CBT |
| CBT individual therapy | Experimental | 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. Receives: Behavioral: Individual CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 52 weeks
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Erik Hedman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667822
- Sponsor's protocol ID
- Self help CBT
- Status last verified
- Oct 2016
- First submitted
- 10 Aug 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
- ClinicalTrials.gov ID
- NCT01667822
- Acronym / sponsor ID
- Self help CBT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued guided self help CBT | Active comparator | Behavioral: Continued self help CBTContinued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total). |
| CBT individual therapy | Experimental | Behavioral: Individual CBTAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- A higher score than 6 on the Clinician severity rating scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continued self help CBTAfter the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session. | Behavioural | Continued guided self help CBT |
| Individual CBTAfter 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. | Behavioural | CBT individual therapy |
Primary outcome
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.
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
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
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
14 secondary outcomes
Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)
Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Work ability index (WAI)
Time frame: Baseline, post-treatment (20 weeks), 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
Health Anxiety Inventory (HAI)
Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Perceived Stress Scale (PSS)
Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 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
Quality of Life Inventory (QOLI)
Time frame: Baseline, post-treatment (20 weeks), 26 feel 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
Sheehan Disability Scales (SDS)
Time frame: Baseline, post-treatment (20 weeks), 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
Obsessive Compulsive Inventory-Revised (OCI-R)
Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Liebowitz Social Anxiety Scale Self-report (LSAS-SR)
Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Panic Disorder Severity Scale Self-rated (PDSS-SR)
Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Penn-State Worry Questionnaire (PSWQ)
Time frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
Related trials for Anxiety Disorders
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Active, not recruiting
Improving Emotional Wellbeing of University Students: Anxiety Management
Anxiety
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continued self help CBT and Individual CBT in people with Anxiety Disorders and Major Depression, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.