Trial · NCT00612807
Treatment of Mood and Marriage Study (TOMMS)
NCT00612807, Phase 1, Phase 2, Completed, Duke University; results first posted 2011-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Mood and Marriage Study (TOMMS). Trials, record NCT00612807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00612807
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Mood and Marriage Study (TOMMS)
- NCT number
- NCT00612807
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Major Depressive Disorder, Partner Relational Disorder (V61.10)
- Interventions
- Weekly marital therapy, As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
- First posted
- 2008-02-12
- Last updated
- 2013-06-24
- Results first posted
- 2011-04-26
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hamilton Depression Rating Scale (HDRS) | pre-treatment, monthly, post-treatment, 6 month follow-up | The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression. |
| Primary | Dyadic Adjustment Scale (DAS) | pre-treatment, monthly, post-treatment, 6 month follow-up | The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning. |
| Secondary | Frequency & Acceptability of Partner Behavior | Pre-treatment, post-treatment, 6 month follow-up | |
| Secondary | Conflict Tactics Scale | pre-treatment, post-treatment, 6 month follow-up | |
| Secondary | SCID Mood Disorders | pre-treatment, post-treatment, 6 month follow-up | |
| Secondary | Personal Assessment of Intimacy in Relationships | pre-treatment, post-treatment, 6 month-followup | |
| Secondary | Beck Anxiety Inventory | pre-treatment, post-treatment, 6 month follow-up |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hamilton Depression Rating Scale (HDRS) | pre-treatment, monthly, post-treatment, 6 month follow-up | Score on HDRS | MEAN | |
| PRIMARY | Dyadic Adjustment Scale (DAS) | pre-treatment, monthly, post-treatment, 6 month follow-up | Score on DAS measure | MEAN | |
| SECONDARY | Frequency & Acceptability of Partner Behavior | Pre-treatment, post-treatment, 6 month follow-up | |||
| SECONDARY | Conflict Tactics Scale | pre-treatment, post-treatment, 6 month follow-up | |||
| SECONDARY | SCID Mood Disorders | pre-treatment, post-treatment, 6 month follow-up | |||
| SECONDARY | Personal Assessment of Intimacy in Relationships | pre-treatment, post-treatment, 6 month-followup | |||
| SECONDARY | Beck Anxiety Inventory | pre-treatment, post-treatment, 6 month follow-up |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management | Baseline assessment (Depressed spouse) | 17.86 | Standard Deviation 2.11 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management + Weekly Marital Therapy | Baseline assessment (Depressed spouse) | 19.0 | Standard Deviation 3.80 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management | Post-test assessment (Depressed spouse) | 5.00 | Standard Deviation 5.44 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management + Weekly Marital Therapy | Post-test assessment (Depressed spouse) | 7.29 | Standard Deviation 5.13 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management | Follow-up assessment (Depressed spouse) | 9.17 | Standard Deviation 7.52 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management + Weekly Marital Therapy | Follow-up assessment (Depressed spouse) | 8.14 | Standard Deviation 5.76 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management | Baseline assessment (Non-depressed spouse) | 5.14 | Standard Deviation 3.76 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management + Weekly Marital Therapy | Baseline assessment (Non-depressed spouse) | 8.86 | Standard Deviation 5.04 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management | Post-test assessment (Non-depressed spouse) | 5.33 | Standard Deviation 6.56 | Score on HDRS |
| Hamilton Depression Rating Scale (HDRS) | Semi-weekly Medication Management + Weekly Marital Therapy | Post-test assessment (Non-depressed spouse) | 3.29 | Standard Deviation 2.67 | Score on HDRS |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semi-weekly Medication Management | 14 | |
| Overall Study | STARTED | Semi-weekly Medication Management + Weekly Marital Therapy | 28 | |
| Overall Study | COMPLETED | Semi-weekly Medication Management | 12 | |
| Overall Study | COMPLETED | Semi-weekly Medication Management + Weekly Marital Therapy | 28 | |
| Overall Study | NOT COMPLETED | Semi-weekly Medication Management | 2 | |
| Overall Study | NOT COMPLETED | Semi-weekly Medication Management + Weekly Marital Therapy | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Passive suicidal ideation | Psychiatric disorders | Semi-weekly Medication Management | 0 | 14 | 0 |
| other | Passive suicidal ideation | Psychiatric disorders | Semi-weekly Medication Management + Weekly Marital Therapy | 2 | 28 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semi-weekly Medication Management | ||
| Total, all-cause mortality | Semi-weekly Medication Management + Weekly Marital Therapy | ||
| Total, other adverse events | Semi-weekly Medication Management | 0 | 14 |
| Total, other adverse events | Semi-weekly Medication Management + Weekly Marital Therapy | 2 | 28 |
| Total, serious adverse events | Semi-weekly Medication Management | 0 | 14 |
| Total, serious adverse events | Semi-weekly Medication Management + Weekly Marital Therapy | 0 | 28 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R34MH073677 | Adapting Marital Therapy in Older Adults with Depression | COMPTON, JILL SERAFIN | DUKE UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2006 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Semi-weekly Medication Management vs Semi-weekly Medication Management + Weekly Marital Therapy: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00612807
GET https://conductscience.org/api/trials/v1/NCT00612807/results?page=2