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Completed

NCT Number: NCT01889342

Metacognitive Therapy Versus Cognitive Behavioral Therapy for Mixed Anxiety Disorders: A Randomized Controlled Trial.

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.

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Key information

Conditions

Mixed Anxiety Disorders Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Modum Bad

Vikersund, Buskerud, 3370, Norway

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Metacognitive Therapy

Behavioral

Cognitive behavioral therapy

Behavioral

Primary outcomes

  1. Anxiety Disorders Interview Schedule for DSM-IV-Lifetime Version

    Time frame: PRE/POST/1 year follow up

    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.

  2. Beck Anxiety Inventory (BAI)

    Time frame: PRE/POST/weekly and 1 year follow up

Secondary outcomes

  1. The Symptom Checklist 90(SCL90; Derogatis et al., 1996)

    Time frame: Pre/Post/1 year follow up

  2. The Patient Health Questionnaire depression module (PHQ 9; Spitzer et al., 1999)

    Time frame: Pre/Post and 1 year follow up

  3. Metacognitions Questionnaire- 30 (MCQ-30; Wells & Cartwright-Hatton, 2003)

    Time frame: Pre/Post/weekly and 1 year follow up

  4. Working Alliance Inventory (WAI; Horwath & Greenberg, 1989)

    Time frame: Pre/Post/weekly and 1 year follow up

  5. Cognitive attentional syndrome 1 (CAS1; Wells, 2009)

    Time frame: Pre/Post/weekly and 1 year follow up

  6. The Repetitive Thinking Questionnaire(RTQ; McEvoy et al., 2010)

    Time frame: Pre/Post and 1 year follow up

  7. PTSD Symptom scale Self Report (PSSR; Foa et al., 1993)

    Time frame: Pre/Post and 1 year follow up

  8. Social Phobia Inventory (SPIN; Connor et al., 2000)

    Time frame: Pre/Post and 1 year follow up

  9. Mobility inventory (MI; Chambless, 1985)

    Time frame: Pre/Post and 1 year follow up

  10. SF 36

    Time frame: Pre/Post and 1 year follow up

  11. The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger & Borkovec, 1990)

    Time frame: Pre/Post and 1 year follow up

  12. Youngs Schema Questionnaire YSQ -75 (Young, 1998)

    Time frame: Pre/Post and 1 year follow up

  13. The Inventory of Interpersonal Problems (IIP 64 C; Horowitz et al., 1988)

    Time frame: Pre/Post and 1 year follow up

  14. Dysfunctional emotion regulations scale (DERS; Graz & Roemer, 2004)

    Time frame: Pre/Post/ and 1 year follow up

Sponsors and collaborators

Lead sponsor

Modum Bad

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 28, 2013
Registry last updated
Mar 8, 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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