Phase 2 N=42 Randomized Single-blind Treatment

Treatment of Mood and Marriage Study (TOMMS)

Major Depressive Disorder · Partner Relational Disorder (V61.10)

Bottom Line

View on ClinicalTrials.gov: NCT00612807 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2011

Primary outcome: Primary: Hamilton Depression Rating Scale (HDRS) — 17.86; 19.0; 5.00; 7.29 Score on HDRS — p=0.056

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Weekly marital therapy (Behavioral); As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc. (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Hamilton Depression Rating Scale (HDRS)	17.86; 19.0; 5.00; 7.29; 9.17; 8.14	0.056
PRIMARY Dyadic Adjustment Scale (DAS)	72.14; 84.43; 84.17; 92.27; 89.67; 91.07	0.32
SECONDARY Frequency & Acceptability of Partner Behavior	—	—
SECONDARY Conflict Tactics Scale	—	—
SECONDARY SCID Mood Disorders	—	—
SECONDARY Personal Assessment of Intimacy in Relationships	—	—
SECONDARY Beck Anxiety Inventory	—	—

Summary

The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.

Eligibility Criteria

Inclusion Criteria

One partner must receive a clinical diagnosis of major depressive disorder based upon our assessment
Couples must be living together
Either partner must report marital distress or tension
Willing to take antidepressant medication and participate in weekly marital therapy and assessments
The depressed partner cannot be involved in any other psychosocial treatment
Score above 24 on the Mini Mental Status Exam

Exclusion Criteria

Both partners meet diagnostic criteria for major depressive disorder based on our evaluation
Coexisting bipolar or psychotic disorder
Evidence of a primary substance abuse or dependence disorder
Current ECT treatment
Evidence of active and severe domestic violence

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00612807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.