Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the level of residual symptoms and psychosocial factors affecting recovery of psychosocial functions in MDD patients who reach remission, and investigate the recovery process of psychosocial functions.
The investigators suppose that even the patient is well-treated by drug,there are still many residual symptoms,and they also exist different degree of damage in the structure and functions of brain. CBT could help them obtain better recovery,especially in psychosocial functions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Objective:At present, clinical remission of depression is defined as a final HAMD score of less than 7. However, in clinical practice, the psychosocial functions of patients who reach remission are far from complete recovery. The recovery of psychosocial functions lags behind the disappearance of symptoms.so,we aim to determine the level of residual symptoms and psychosocial factors affecting recovery of psychosocial functions in MDD patients who reach remission, and investigate the recovery process of psychosocial functions.
Method:200 MDD patients who met the inclusion criteria were randomly divided into CBT group and control group.All of subjects would complete the psychological assessment at 0,1st,2nd,6th and 12th months for CBT group and 0,2nd,12th months for control group.ALL participants would undergo magnetic resonance imaging at 0,2nd,12th months.The scanning sequence is 3D,resting-state,task-state and diffusion tensor imaging（DTI）.During the magnetic resonance imaging（MRI） scans, subjects performed the facial and gender recognition tasks with three different facial stimuli(positive/neutral/negative).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: medicine combined CBT Besides clinical routine antidepressant treatment,participants receive CBT weekly for 8 weeks and monthly until the end of the study. |
Behavioral: medicine combined CBT
medicine：Clinical routine antidepressant treatment CBT：During the treatment period，weekly for 8 weeks，and monthly for the maintenance phase.Therapists receive group supervision monthly.
Other Names:
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| Other: medicine (SSRI antidepressants) clinical routine antidepressant treatment--Selective serotonin reuptake inhibitors（SSRIs）. |
Drug: medicine
Participants receive only clinical routine antidepressant treatment,Which include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa) ;escitalopram (Lexapro) and fluvoxamine (Luvox). It will be chosen according to special condition of every patient.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Hamilton Rating Scale for Depression (HAMD） [one year]
The 24-item version of the Hamilton Rating Scale for Depression (HAMD; Hamilton, 1960) will be used for measuring severity of depressive symptoms.remission of depression is defined as a final HAMD score of less than 7.
Secondary Outcome Measures
- Magnetic Resonance Imaging [one year]
Scanning sequency：3D、resting-state、task-state、Diffusion Tensor Imaging（DTI） Task:explicit and implicit emotional processes.
- The Beck Depression Inventory (BDI) [one year]
The Beck Depression Inventory (BDI), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.
- Generic Quality of Life Inventory-74 [one year]
Generic Quality of Life Inventory-74(GQOLI-74)created by Dr.Yang Desen and Dr. Li Lingjiang in 1998. It will be used for measuring the quality of life,efficacy and side effect.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of major depressive disorder (MDD)
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Hamilton Rating Scale for Depression(HAMD) less than 7
Exclusion Criteria:
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Bipolar disorder
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Substance dependence
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Neurological disorder or other mental disorder
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Severe body disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing Brain Hospital | Nanjing | Jiangsu | China | 210029 |
Sponsors and Collaborators
- Nanjing Medical University
Investigators
- Principal Investigator: Zhang Ning, Nanjing Brain Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Kuehner C. An evaluation of the 'Coping with Depression Course' for relapse prevention with unipolar depressed patients. Psychother Psychosom. 2005;74(4):254-9.
- Mattisson C, Bogren M, Horstmann V, Munk-Jörgensen P, Nettelbladt P. The long-term course of depressive disorders in the Lundby Study. Psychol Med. 2007 Jun;37(6):883-91. Epub 2007 Feb 19.
- Paykel ES, Scott J, Teasdale JD, Johnson AL, Garland A, Moore R, Jenaway A, Cornwall PL, Hayhurst H, Abbott R, Pope M. Prevention of relapse in residual depression by cognitive therapy: a controlled trial. Arch Gen Psychiatry. 1999 Sep;56(9):829-35.
- Petersen TJ. Enhancing the efficacy of antidepressants with psychotherapy. J Psychopharmacol. 2006 May;20(3 Suppl):19-28. Review.
- Scott J, Teasdale JD, Paykel ES, Johnson AL, Abbott R, Hayhurst H, Moore R, Garland A. Effects of cognitive therapy on psychological symptoms and social functioning in residual depression. Br J Psychiatry. 2000 Nov;177:440-6.
- Vitiello B. Combined cognitive-behavioural therapy and pharmacotherapy for adolescent depression: Does it improve outcomes compared with monotherapy? CNS Drugs. 2009;23(4):271-80.
- Watkins E, Scott J, Wingrove J, Rimes K, Bathurst N, Steiner H, Kennell-Webb S, Moulds M, Malliaris Y. Rumination-focused cognitive behaviour therapy for residual depression: a case series. Behav Res Ther. 2007 Sep;45(9):2144-54. Epub 2007 Mar 26.
- ZKX10022