Major Depressive Disorder Clinical Trial
Official title:
A Randomized Controlled Trial of the Effectiveness of Metacognitive Therapy (MCT) in the Treatment of Patients With Major Depressive Disorder (MDD)
NCT number | NCT01608399 |
Other study ID # | MCTDEP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | June 2016 |
Verified date | August 2019 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main aim of this study is to (1) evaluate the effectiveness of metacognitive therapy for major depressive disorder. Additional aims are to (2) investigate patterns of change and the mechanisms of action involved during treatment, and to (3) examine the impact of meta-cognitions in the treatment and relapse prevention of depression.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Major depressive disorder - 18 years or older - Signed written informed consent prior to entry in the study Exclusion Criteria: - Known somatic disease - Psychosis - Current suicide intent - PTSD - Cluster A or cluster B personality disorder - Substance dependence - Not willing to accept random allocation - Not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial |
Country | Name | City | State |
---|---|---|---|
Norway | Department of psychology, Norwegian University of Science and Technology | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology |
Norway,
Hagen R, Hjemdal O, Solem S, Kennair LE, Nordahl HM, Fisher P, Wells A. Metacognitive Therapy for Depression in Adults: A Waiting List Randomized Controlled Trial with Six Months Follow-Up. Front Psychol. 2017 Jan 24;8:31. doi: 10.3389/fpsyg.2017.00031. e — View Citation
Hjemdal O, Solem S, Hagen R, Kennair LEO, Nordahl HM, Wells A. A Randomized Controlled Trial of Metacognitive Therapy for Depression: Analysis of 1-Year Follow-Up. Front Psychol. 2019 Aug 8;10:1842. doi: 10.3389/fpsyg.2019.01842. eCollection 2019. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in depression | Hamilton Depression Rating Scale (HDRS-17; Hamilton, 1967) | baseline (before treatment), week 1-11, 12 months follow-up | |
Primary | Change in diagnosis | SCID I and II (First et al., 1995, 1997) | baseline (before treatment), week 11, 12 months follow-up | |
Secondary | Change in depression | Major Depressive Disorder Scale (MDD-S; Wells, 2009) | baseline (before treatment), week 1-11, 6 and 12 months follow-up | |
Secondary | Change in anxiety | Beck Anxiety Inventory (BAI; Beck et al., 1988) | baseline (before treatment), week 1-11, 6 and 12 months follow-up | |
Secondary | Change in automatic thought | Automatic Thought Questionnaire (ATQ; hollon & Kendall, | baseline (before treatment), week 11, 6 and 12 months follow-up | |
Secondary | Change in rumination | Rumination Response Scale (RRS; Nolen-Hoeksema & Morrow, 1991) | baseline (before treatment), week 11, 6 and 12 months follow-up | |
Secondary | Change in positive beliefs | Positive beliefs about Rumination (PBRS; Papageorgiou & Wells, 2001) | baseline (before treatment), week 11, 6 and 12 months follow-up | |
Secondary | Change in negative beliefs | Negative Beliefs about Rumination (NBRS; Papageorgiou & Wells, 2008) | baseline (before treatment), week 11, 6 and 12 months follow-up | |
Secondary | Change in metacognitions | Metacognitions Questionnaire-30 (MCQ-30; Wells & Cartwright-Hatton, 2003) | baseline (before treatment), week 11, 6 and 12 months follow-up | |
Secondary | Change in resilience | Resilience Scale for Adults (RSA; Friborg & Hjemdal, 2003) | baseline (before treatment), week 11, 6 and 12 months follow-up | |
Secondary | Change in interpersonal problems | Inventory of Interpersonal Problems (IIP-64; Horowitz et al., 1988) | baseline (before treatment), week 11, 6 and 12 months follow-up | |
Secondary | Change in worry | Penn Scale Worry Questionnaire (PSWQ; Meyer et al., 1990) | baseline (before treatment), week 11, 6 and 12 months follow-up | |
Secondary | Quality of working alliance | Working Alliance Inventory (Horvath & Greenberg, 1989) | week 3 |
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