Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34MH073677-01A2 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Medication management with a study doctor every other week. |
|
| Combination | Experimental | Medication management with a study doctor every other week plus weekly marital therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weekly marital therapy | Behavioral | Weekly marital therapy for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre-treatment, monthly, post-treatment, 6 month follow-up |
| 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. | pre-treatment, monthly, post-treatment, 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency & Acceptability of Partner Behavior | Pre-treatment, post-treatment, 6 month follow-up | |
| Conflict Tactics Scale | pre-treatment, post-treatment, 6 month follow-up | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jill S. Compton, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Child & Family Studies Center; Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2378693 | Background | Futterman A, Gallagher D, Thompson LW, Lovett S, Gilewski M. Retrospective assessment of marital adjustment and depression during the first 2 years of spousal bereavement. Psychol Aging. 1990 Jun;5(2):277-83. doi: 10.1037//0882-7974.5.2.277. | |
| Background | 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. | ||
| 1550090 |
Not provided
Not provided
No participants who met eligibility criteria were excluded before assignment to treatment condition.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Semi-weekly Medication Management | Medication management with a study doctor every other week. |
| FG001 | Semi-weekly Medication Management + Weekly Marital Therapy | Medication management with a study doctor every other week plus weekly marital therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Semi-weekly Medication Management | Medication management with a study doctor every other week. |
| BG001 | Semi-weekly Medication Management + Weekly Marital Therapy | Medication management with a study doctor every other week plus weekly marital therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Score on HDRS | pre-treatment, monthly, post-treatment, 6 month follow-up |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Semi-weekly Medication Management | Medication management with a study doctor every other week. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Passive suicidal ideation | Psychiatric disorders | Systematic Assessment | Passive suicidal ideation without intent to act. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Compton, Ph.D. | Duke University Medical Center | 919-416-2089 | compton@duke.edu |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D016642 | Bupropion |
| D000069470 | Venlafaxine Hydrochloride |
| D009661 | Nortriptyline |
| D014191 | Tranylcypromine |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D003511 | Cyclohexanols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc. | Drug | 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) |
|
| SCID Mood Disorders |
| pre-treatment, post-treatment, 6 month follow-up |
| Personal Assessment of Intimacy in Relationships | pre-treatment, post-treatment, 6 month-followup |
| Beck Anxiety Inventory | pre-treatment, post-treatment, 6 month follow-up |
| Background |
| Oxman TE, Berkman LF, Kasl S, Freeman DH Jr, Barrett J. Social support and depressive symptoms in the elderly. Am J Epidemiol. 1992 Feb 15;135(4):356-68. doi: 10.1093/oxfordjournals.aje.a116297. |
| 8749590 | Background | Tower RB, Kasl SV. Depressive symptoms across older spouses and the moderating effect of marital closeness. Psychol Aging. 1995 Dec;10(4):625-38. doi: 10.1037//0882-7974.10.4.625. |
| 10439302 | Background | Gerson S, Belin TR, Kaufman A, Mintz J, Jarvik L. Pharmacological and psychological treatments for depressed older patients: a meta-analysis and overview of recent findings. Harv Rev Psychiatry. 1999 May-Jun;7(1):1-28. |
| 6829547 | Background | Murrell SA, Himmelfarb S, Wright K. Prevalence of depression and its correlates in older adults. Am J Epidemiol. 1983 Feb;117(2):173-85. doi: 10.1093/oxfordjournals.aje.a113528. |
| 3942473 | Background | Simons AD, Murphy GE, Levine JL, Wetzel RD. Cognitive therapy and pharmacotherapy for depression. Sustained improvement over one year. Arch Gen Psychiatry. 1986 Jan;43(1):43-8. doi: 10.1001/archpsyc.1986.01800010045006. |
| 2647712 | Background | Baldessarini RJ. Current status of antidepressants: clinical pharmacology and therapy. J Clin Psychiatry. 1989 Apr;50(4):117-26. |
| 8034832 | Background | Scogin F, McElreath L. Efficacy of psychosocial treatments for geriatric depression: a quantitative review. J Consult Clin Psychol. 1994 Feb;62(1):69-74. doi: 10.1037//0022-006x.62.1.69. |
| 9366657 | Background | Thase ME, Greenhouse JB, Frank E, Reynolds CF 3rd, Pilkonis PA, Hurley K, Grochocinski V, Kupfer DJ. Treatment of major depression with psychotherapy or psychotherapy-pharmacotherapy combinations. Arch Gen Psychiatry. 1997 Nov;54(11):1009-15. doi: 10.1001/archpsyc.1997.01830230043006. |
| 9892449 | Background | Reynolds CF 3rd, Frank E, Perel JM, Imber SD, Cornes C, Miller MD, Mazumdar S, Houck PR, Dew MA, Stack JA, Pollock BG, Kupfer DJ. Nortriptyline and interpersonal psychotherapy as maintenance therapies for recurrent major depression: a randomized controlled trial in patients older than 59 years. JAMA. 1999 Jan 6;281(1):39-45. doi: 10.1001/jama.281.1.39. |
| 7264067 | Background | Holahan CJ, Moos RH. Social support and psychological distress: a longitudinal analysis. J Abnorm Psychol. 1981 Aug;90(4):365-70. doi: 10.1037//0021-843x.90.4.365. No abstract available. |
| 2590779 | Background | George LK, Blazer DG, Hughes DC, Fowler N. Social support and the outcome of major depression. Br J Psychiatry. 1989 Apr;154:478-85. doi: 10.1192/bjp.154.4.478. |
| 8046584 | Background | Levenson RW, Carstensen LL, Gottman JM. The influence of age and gender on affect, physiology, and their interrelations: a study of long-term marriages. J Pers Soc Psychol. 1994 Jul;67(1):56-68. doi: 10.1037//0022-3514.67.1.56. |
| 2647802 | Background | Jacobson NS, Holtzworth-Munroe A, Schmaling KB. Marital therapy and spouse involvement in the treatment of depression, agoraphobia, and alcoholism. J Consult Clin Psychol. 1989 Feb;57(1):5-10. doi: 10.1037//0022-006x.57.1.5. |
| Background | 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. |
| 1918559 | Background | Jacobson NS, Dobson K, Fruzzetti AE, Schmaling KB, Salusky S. Marital therapy as a treatment for depression. J Consult Clin Psychol. 1991 Aug;59(4):547-57. doi: 10.1037//0022-006x.59.4.547. |
| 8326054 | Background | Jacobson NS, Fruzzetti AE, Dobson K, Whisman M, Hops H. Couple therapy as a treatment for depression: II. The effects of relationship quality and therapy on depressive relapse. J Consult Clin Psychol. 1993 Jun;61(3):516-9. doi: 10.1037//0022-006x.61.3.516. |
| 2301656 | Background | O'Leary KD, Beach SR. Marital therapy: a viable treatment for depression and marital discord. Am J Psychiatry. 1990 Feb;147(2):183-6. doi: 10.1176/ajp.147.2.183. |
| 11026946 | Background | Leff J, Vearnals S, Brewin CR, Wolff G, Alexander B, Asen E, Dayson D, Jones E, Chisholm D, Everitt B. The London Depression Intervention Trial. Randomised controlled trial of antidepressants v. couple therapy in the treatment and maintenance of people with depression living with a partner: clinical outcome and costs. Br J Psychiatry. 2000 Aug;177:95-100. doi: 10.1192/bjp.177.2.95. |
| 10780137 | Background | Jacobson NS, Christensen A, Prince SE, Cordova J, Eldridge K. Integrative behavioral couple therapy: an acceptance-based, promising new treatment for couple discord. J Consult Clin Psychol. 2000 Apr;68(2):351-5. doi: 10.1037//0022-006x.68.2.351. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on DAS measure | pre-treatment, monthly, post-treatment, 6 month follow-up |
|
|
|
|
| Secondary | Frequency & Acceptability of Partner Behavior | Not Posted | Pre-treatment, post-treatment, 6 month follow-up |
| Secondary | Conflict Tactics Scale | Not Posted | pre-treatment, post-treatment, 6 month follow-up |
| Secondary | SCID Mood Disorders | Not Posted | pre-treatment, post-treatment, 6 month follow-up |
| Secondary | Personal Assessment of Intimacy in Relationships | Not Posted | pre-treatment, post-treatment, 6 month-followup |
| Secondary | Beck Anxiety Inventory | Not Posted | pre-treatment, post-treatment, 6 month follow-up |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Semi-weekly Medication Management + Weekly Marital Therapy | Medication management with a study doctor every other week plus weekly marital therapy. | 0 | 28 | 2 | 28 |
|
Not provided
Not provided
| D000441 |
| Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D011437 | Propylamines |
| Follow-up assessment (Depressed spouse) |
|
| Baseline assessment (Non-depressed spouse) |
|
| Post-test assessment (Non-depressed spouse) |
|
| Follow-up assessment (Non-depressed spouse) |
|
Testing whether slope of change over time varied by identified patient status and treatment condition. |
| 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. | Fixed effect in multi-level model | 0.005 | We probed this interaction and discovered that at each assessment, spouses in the couple therapy + medication treatment group reported greater dyadic adjustment than did spouses in the medication alone condition (b = 10.53, z = 2.72, p = 0.006). | Interaction term | -12.97 | Standard Error of the Mean | 4.52 | 95 | Yes | Non-Inferiority or Equivalence | Testing whether means at each timepoint varied by identified patient status and treatment condition. |