Treatment of Mood and Marriage Study (TOMMS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00612807
First received: January 2, 2008
Last updated: June 17, 2013
Last verified: March 2011
Results First Received: February 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Major Depressive Disorder
Partner Relational Disorder (V61.10)
Interventions: Behavioral: Weekly marital therapy
Drug: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Older, maritally-distressed couples with a depressed spouse were recruited via flyers and referral for participation in a study on couples therapy in older adults. Recruitment for Phase I occurred from 10/2006 to 5/2007; recruitment for Phase II occurred from 7/2007 to 5/2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No participants who met eligibility criteria were excluded before assignment to treatment condition.

Reporting Groups
  Description
Semi-weekly Medication Management Medication management with a study doctor every other week.
Semi-weekly Medication Management + Weekly Marital Therapy Medication management with a study doctor every other week plus weekly marital therapy.

Participant Flow:   Overall Study
    Semi-weekly Medication Management     Semi-weekly Medication Management + Weekly Marital Therapy  
STARTED     14     28  
COMPLETED     12     28  
NOT COMPLETED     2     0  
Withdrawal by Subject                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Semi-weekly Medication Management Medication management with a study doctor every other week.
Semi-weekly Medication Management + Weekly Marital Therapy Medication management with a study doctor every other week plus weekly marital therapy.
Total Total of all reporting groups

Baseline Measures
    Semi-weekly Medication Management     Semi-weekly Medication Management + Weekly Marital Therapy     Total  
Number of Participants  
[units: participants]
  14     28     42  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     10     13  
>=65 years     11     18     29  
Age  
[units: years]
Mean ± Standard Deviation
  71.2  ± 6.0     67.2  ± 7.5     68.5  ± 7.2  
Gender  
[units: participants]
     
Female     7     14     21  
Male     7     14     21  
Region of Enrollment  
[units: participants]
     
United States     14     28     42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale (HDRS)   [ Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up ]

2.  Primary:   Dyadic Adjustment Scale (DAS)   [ Time Frame: pre-treatment, monthly, post-treatment, 6 month follow-up ]

3.  Secondary:   Frequency & Acceptability of Partner Behavior   [ Time Frame: Pre-treatment, post-treatment, 6 month follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Conflict Tactics Scale   [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   SCID Mood Disorders   [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Personal Assessment of Intimacy in Relationships   [ Time Frame: pre-treatment, post-treatment, 6 month-followup ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Beck Anxiety Inventory   [ Time Frame: pre-treatment, post-treatment, 6 month follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size limits power to detect differences. Some participants reported difficulty understanding how to complete the questions, which may introduce additional variability into the data.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jill Compton, Ph.D.
Organization: Duke University Medical Center
phone: 919-416-2089
e-mail: compton@duke.edu


Publications:
Jacobson, N.S. & Christensen, A. (1996). Acceptance and Change in Couple Therapy: A Therapist's Guide to Transforming Relationships. New York: W.W. Norton & Company, Inc.
O'Leary, KD, Christian, JL, & Mendell, NR (1994). A closer look at the link between marital discord and depressive symptomatology. Journal of Social and Clinical Psychology, 13, 33-41.


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00612807     History of Changes
Other Study ID Numbers: Pro00008099, R34 MH073677-01A2
Study First Received: January 2, 2008
Results First Received: February 16, 2011
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board