Mixed Anxiety Disorders Clinical Trial
Official title:
Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.
| Verified date | March 2016 |
| Source | Modum Bad |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway:National Committee for Medical and Health Research Ethics |
| Study type | Interventional |
Comorbidity is normal in clinical practice. Metacognitive Therapy (MCT) is a transdiagnostic
model and could therefore be well suited when it comes to treating patients with high rates
of comorbidity. So far, no studies have examined MCT in comparison with the best documented
and evidence based treatment, cognitive behavioral treatment(CBT), in a randomized
controlled trial consisting of mixed anxiety disorder sample with high degree of
comorbidity.
The main aim of this study is to 1) Evaluate the effectiveness of metacognitive therapy in a
sample of mixed anxiety disorders as compared to a group receiving existing evidence-based
single diagnosis CBT- treatment protocols 2) Investigate patterns and mechanisms of change
in the two treatments.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - DSM IV diagnoses of SAD, PD/A or PTSD (CSR>4) - Withdraw of all psychotropic medications before treatment Exclusion Criteria: - Psychosis - Not willing to accept randomization - Comorbid conditions are in immediate need of treatment |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Norway | Modum Bad | Vikersund | Buskerud |
| Lead Sponsor | Collaborator |
|---|---|
| Modum Bad |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version | The ADIS -IV is a semistructured diagnostic interview designed to establish reliable DSM-IV anxiety, mood, somatoform and substance disorders. Interviewers assign a 0-8 clinical severity rating (CSR), that indicate their judgement of the degree of distress. | PRE/POST/1 year follow up | No |
| Primary | Beck Anxiety Inventory (BAI) | PRE/POST/weekly and 1 year follow up | No | |
| Secondary | The Symptom Checklist 90(SCL90; Derogatis et al., 1996) | Pre/Post/1 year follow up | No | |
| Secondary | The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999) | Pre/Post and 1 year follow up | No | |
| Secondary | Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003) | Pre/Post/weekly and 1 year follow up | No | |
| Secondary | Working Alliance Inventory (WAI; Horwath & Greenberg, 1989) | Pre/Post/weekly and 1 year follow up | No | |
| Secondary | Cognitive attentional syndrome 1 (CAS1; Wells, 2009) | Pre/Post/weekly and 1 year follow up | No | |
| Secondary | The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010) | Pre/Post and 1 year follow up | No | |
| Secondary | PTSD Symptom scale Self Report (PSSR; Foa et al., 1993) | Pre/Post and 1 year follow up | No | |
| Secondary | Social Phobia Inventory (SPIN; Connor et al., 2000) | Pre/Post and 1 year follow up | No | |
| Secondary | Mobility inventory (MI; Chambless, 1985) | Pre/Post and 1 year follow up | No | |
| Secondary | SF 36 | Pre/Post and 1 year follow up | No | |
| Secondary | The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990) | Pre/Post and 1 year follow up | No | |
| Secondary | Youngs Schema Questionnaire YSQ -75 (Young, 1998) | Pre/Post and 1 year follow up | No | |
| Secondary | The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988) | Pre/Post and 1 year follow up | No | |
| Secondary | Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004) | Pre/Post/ and 1 year follow up | No |