Trial Outcomes & Findings for Treatment of Mood and Marriage Study (TOMMS) (NCT NCT00612807)
NCT ID: NCT00612807
Last Updated: 2013-06-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
pre-treatment, monthly, post-treatment, 6 month follow-up
Results posted on
2013-06-24
Participant Flow
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.
No participants who met eligibility criteria were excluded before assignment to treatment condition.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
28
|
|
Overall Study
COMPLETED
|
12
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Treatment of Mood and Marriage Study (TOMMS)
Baseline characteristics by cohort
| Measure |
Semi-weekly Medication Management
n=14 Participants
Medication management with a study doctor every other week.
|
Semi-weekly Medication Management + Weekly Marital Therapy
n=28 Participants
Medication management with a study doctor every other week plus weekly marital therapy.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age Continuous
|
71.2 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
68.5 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
28 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-treatment, monthly, post-treatment, 6 month follow-upThe 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.
Outcome measures
| Measure |
Semi-weekly Medication Management
n=14 Participants
Medication management with a study doctor every other week.
|
Semi-weekly Medication Management + Weekly Marital Therapy
n=28 Participants
Medication management with a study doctor every other week plus weekly marital therapy.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HDRS)
Post-test assessment (Non-depressed spouse)
|
5.33 Score on HDRS
Standard Deviation 6.56
|
3.29 Score on HDRS
Standard Deviation 2.67
|
|
Hamilton Depression Rating Scale (HDRS)
Baseline assessment (Depressed spouse)
|
17.86 Score on HDRS
Standard Deviation 2.11
|
19.0 Score on HDRS
Standard Deviation 3.80
|
|
Hamilton Depression Rating Scale (HDRS)
Post-test assessment (Depressed spouse)
|
5.00 Score on HDRS
Standard Deviation 5.44
|
7.29 Score on HDRS
Standard Deviation 5.13
|
|
Hamilton Depression Rating Scale (HDRS)
Follow-up assessment (Depressed spouse)
|
9.17 Score on HDRS
Standard Deviation 7.52
|
8.14 Score on HDRS
Standard Deviation 5.76
|
|
Hamilton Depression Rating Scale (HDRS)
Baseline assessment (Non-depressed spouse)
|
5.14 Score on HDRS
Standard Deviation 3.76
|
8.86 Score on HDRS
Standard Deviation 5.04
|
|
Hamilton Depression Rating Scale (HDRS)
Follow-up assessment (Non-depressed spouse)
|
3.83 Score on HDRS
Standard Deviation 2.99
|
5.71 Score on HDRS
Standard Deviation 4.06
|
PRIMARY outcome
Timeframe: pre-treatment, monthly, post-treatment, 6 month follow-upThe 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.
Outcome measures
| Measure |
Semi-weekly Medication Management
n=14 Participants
Medication management with a study doctor every other week.
|
Semi-weekly Medication Management + Weekly Marital Therapy
n=28 Participants
Medication management with a study doctor every other week plus weekly marital therapy.
|
|---|---|---|
|
Dyadic Adjustment Scale (DAS)
Baseline assessment (Depressed spouse)
|
72.14 Score on DAS measure
Standard Deviation 24.30
|
84.43 Score on DAS measure
Standard Deviation 11.89
|
|
Dyadic Adjustment Scale (DAS)
Post-test assessment (Depressed spouse)
|
84.17 Score on DAS measure
Standard Deviation 23.17
|
92.27 Score on DAS measure
Standard Deviation 16.27
|
|
Dyadic Adjustment Scale (DAS)
Follow-up assessment (Depressed spouse)
|
89.67 Score on DAS measure
Standard Deviation 24.23
|
91.07 Score on DAS measure
Standard Deviation 19.85
|
|
Dyadic Adjustment Scale (DAS)
Baseline assessment (Non-depressed spouse)
|
91.0 Score on DAS measure
Standard Deviation 18.32
|
88.29 Score on DAS measure
Standard Deviation 15.46
|
|
Dyadic Adjustment Scale (DAS)
Post-test assessment (Non-depressed spouse)
|
93.33 Score on DAS measure
Standard Deviation 29.75
|
97.57 Score on DAS measure
Standard Deviation 17.49
|
|
Dyadic Adjustment Scale (DAS)
Follow-up assessment (Non-depressed spouse)
|
104.17 Score on DAS measure
Standard Deviation 13.76
|
98.31 Score on DAS measure
Standard Deviation 20.52
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatment, 6 month follow-upOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-treatment, post-treatment, 6 month follow-upOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-treatment, post-treatment, 6 month follow-upOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-treatment, post-treatment, 6 month-followupOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-treatment, post-treatment, 6 month follow-upOutcome measures
Outcome data not reported
Adverse Events
Semi-weekly Medication Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Semi-weekly Medication Management + Weekly Marital Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Semi-weekly Medication Management
n=14 participants at risk
Medication management with a study doctor every other week.
|
Semi-weekly Medication Management + Weekly Marital Therapy
n=28 participants at risk
Medication management with a study doctor every other week plus weekly marital therapy.
|
|---|---|---|
|
Psychiatric disorders
Passive suicidal ideation
|
0.00%
0/14
|
7.1%
2/28 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place