Major Depressive Disorder, Partner Relational Disorder (V61.10)
Conditions
Keywords
Older Adults
Brief summary
The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.
Detailed description
Major depression has been associated with many individual and interpersonal problems in later life, including inadequate social support, marital distress, spousal depression, poor physical health, and higher rates of mortality. Marital therapy has shown promise as a treatment for depression and coexisting marital distress in younger cohorts, and there is a robust association between social support and depressive symptoms in older adults. The combination of couple therapy and antidepressant medication may provide an ideal treatment for older adults by targeting interpersonal and biochemical aspects of depression. Couples interested in this study will complete an initial assessment with study personnel. In Phase I, eligible couples will receive weekly marital therapy and the depressed partner will receive medication management with a study doctor for 6 months. In Phase II, couples will be randomly assigned to either the combination treatment (marital therapy plus medication management) or medication management alone for 6 months. At the end of the treatment phase, a thorough assessment will be completed. A follow-up assessment will be completed 6 months after completion of treatment.
Interventions
BEHAVIORALWeekly marital therapy
Weekly marital therapy for 6 months.
DRUGAs indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approach; Steffens, 2002). SSRIs (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine) SNRIs (e.g., venlafaxine) Bupropion SR (achieve dose of at least 150 mg BID) Mirtazapine Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl) Lithium augmentation MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)
Sponsors
National Institutes of Health (NIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame |
|---|---|
| SCID Mood Disorders | pre-treatment, post-treatment, 6 month follow-up |
| Frequency & Acceptability of Partner Behavior | Pre-treatment, post-treatment, 6 month follow-up |
| Beck Anxiety Inventory | pre-treatment, post-treatment, 6 month follow-up |
| Personal Assessment of Intimacy in Relationships | pre-treatment, post-treatment, 6 month-followup |
| Conflict Tactics Scale | pre-treatment, post-treatment, 6 month follow-up |
Countries
United States
Participant flow
Recruitment details
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
No participants who met eligibility criteria were excluded before assignment to treatment condition.
Participants by arm
| Arm | Count |
|---|---|
| Semi-weekly Medication Management Medication management with a study doctor every other week. | 14 |
| Semi-weekly Medication Management + Weekly Marital Therapy Medication management with a study doctor every other week plus weekly marital therapy. | 28 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Semi-weekly Medication Management + Weekly Marital Therapy | Semi-weekly Medication Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 11 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 3 Participants | 13 Participants |
| Age Continuous | 67.2 years STANDARD_DEVIATION 7.5 | 71.2 years STANDARD_DEVIATION 6 | 68.5 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 28 participants | 14 participants | 42 participants |
| Sex: Female, Male Female | 14 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 7 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 2 / 28 |
| serious Total, serious adverse events | 0 / 14 | 0 / 28 |
Outcome results
Primary
Dyadic Adjustment Scale (DAS)
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.
Time frame: pre-treatment, monthly, post-treatment, 6 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semi-weekly Medication Management | Dyadic Adjustment Scale (DAS) | Baseline assessment (Depressed spouse) | 72.14 Score on DAS measure | Standard Deviation 24.3 |
| Semi-weekly Medication Management | Dyadic Adjustment Scale (DAS) | Post-test assessment (Depressed spouse) | 84.17 Score on DAS measure | Standard Deviation 23.17 |
| Semi-weekly Medication Management | Dyadic Adjustment Scale (DAS) | Follow-up assessment (Depressed spouse) | 89.67 Score on DAS measure | Standard Deviation 24.23 |
| Semi-weekly Medication Management | Dyadic Adjustment Scale (DAS) | Baseline assessment (Non-depressed spouse) | 91.0 Score on DAS measure | Standard Deviation 18.32 |
| Semi-weekly Medication Management | Dyadic Adjustment Scale (DAS) | Post-test assessment (Non-depressed spouse) | 93.33 Score on DAS measure | Standard Deviation 29.75 |
| Semi-weekly Medication Management | Dyadic Adjustment Scale (DAS) | Follow-up assessment (Non-depressed spouse) | 104.17 Score on DAS measure | Standard Deviation 13.76 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Dyadic Adjustment Scale (DAS) | Post-test assessment (Non-depressed spouse) | 97.57 Score on DAS measure | Standard Deviation 17.49 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Dyadic Adjustment Scale (DAS) | Baseline assessment (Depressed spouse) | 84.43 Score on DAS measure | Standard Deviation 11.89 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Dyadic Adjustment Scale (DAS) | Baseline assessment (Non-depressed spouse) | 88.29 Score on DAS measure | Standard Deviation 15.46 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Dyadic Adjustment Scale (DAS) | Post-test assessment (Depressed spouse) | 92.27 Score on DAS measure | Standard Deviation 16.27 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Dyadic Adjustment Scale (DAS) | Follow-up assessment (Non-depressed spouse) | 98.31 Score on DAS measure | Standard Deviation 20.52 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Dyadic Adjustment Scale (DAS) | Follow-up assessment (Depressed spouse) | 91.07 Score on DAS measure | Standard Deviation 19.85 |
Comparison: Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.p-value: 0.32Fixed effect in multi-level model
Comparison: Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.p-value: 0.005Fixed effect in multi-level model
Primary
Hamilton Depression Rating Scale (HDRS)
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.
Time frame: pre-treatment, monthly, post-treatment, 6 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semi-weekly Medication Management | Hamilton Depression Rating Scale (HDRS) | Baseline assessment (Depressed spouse) | 17.86 Score on HDRS | Standard Deviation 2.11 |
| Semi-weekly Medication Management | Hamilton Depression Rating Scale (HDRS) | Post-test assessment (Depressed spouse) | 5.00 Score on HDRS | Standard Deviation 5.44 |
| Semi-weekly Medication Management | Hamilton Depression Rating Scale (HDRS) | Follow-up assessment (Depressed spouse) | 9.17 Score on HDRS | Standard Deviation 7.52 |
| Semi-weekly Medication Management | Hamilton Depression Rating Scale (HDRS) | Baseline assessment (Non-depressed spouse) | 5.14 Score on HDRS | Standard Deviation 3.76 |
| Semi-weekly Medication Management | Hamilton Depression Rating Scale (HDRS) | Post-test assessment (Non-depressed spouse) | 5.33 Score on HDRS | Standard Deviation 6.56 |
| Semi-weekly Medication Management | Hamilton Depression Rating Scale (HDRS) | Follow-up assessment (Non-depressed spouse) | 3.83 Score on HDRS | Standard Deviation 2.99 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Hamilton Depression Rating Scale (HDRS) | Post-test assessment (Non-depressed spouse) | 3.29 Score on HDRS | Standard Deviation 2.67 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Hamilton Depression Rating Scale (HDRS) | Baseline assessment (Depressed spouse) | 19.0 Score on HDRS | Standard Deviation 3.8 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Hamilton Depression Rating Scale (HDRS) | Baseline assessment (Non-depressed spouse) | 8.86 Score on HDRS | Standard Deviation 5.04 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Hamilton Depression Rating Scale (HDRS) | Post-test assessment (Depressed spouse) | 7.29 Score on HDRS | Standard Deviation 5.13 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Hamilton Depression Rating Scale (HDRS) | Follow-up assessment (Non-depressed spouse) | 5.71 Score on HDRS | Standard Deviation 4.06 |
| Semi-weekly Medication Management + Weekly Marital Therapy | Hamilton Depression Rating Scale (HDRS) | Follow-up assessment (Depressed spouse) | 8.14 Score on HDRS | Standard Deviation 5.76 |
Comparison: Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.p-value: 0.056Fixed effect in multi-level model
Secondary
Beck Anxiety Inventory
Time frame: pre-treatment, post-treatment, 6 month follow-up
Secondary
Conflict Tactics Scale
Time frame: pre-treatment, post-treatment, 6 month follow-up
Secondary
Frequency & Acceptability of Partner Behavior
Time frame: Pre-treatment, post-treatment, 6 month follow-up
Secondary
Personal Assessment of Intimacy in Relationships
Time frame: pre-treatment, post-treatment, 6 month-followup
Secondary
SCID Mood Disorders
Time frame: pre-treatment, post-treatment, 6 month follow-up