Coping With Depression in Parkinson's Disease

NCT00464464 | Completed Results

• 1 other identifier: 0220060139
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment, that includes a caregiver-focused social support intervention, for depression in persons with Parkinson's disease. Individuals who are unable to travel to the study site, but are interested in participating and meet all other eligibility requirements, will be allowed to participate over the phone.

Conditions

Parkinson's Disease; Depression

Keywords

Parkinson's disease; PD; depression; cognitive-behavioral therapy; social support

Outcome Measures

Primary Outcomes (4)

• Hamilton Depression Rating Scale: Baseline

  This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the outset of the trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.

  0 weeks

• Hamilton Depression Rating Scale: Midpoint

  This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, after 5 weeks of the trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.

  5 weeks

• Hamilton Depression Rating Scale: Endpoint

  This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the end of the 10 week trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.

  10 weeks

• Hamilton Depression Rating Scale: Follow-Up Evaluation

  This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, 4 weeks after the trial ended. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.

  14 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

cognitive-behavioral therapy

Behavioral: cognitive-behavioral therapy

2

NO INTERVENTION

standard medical care

Interventions

cognitive-behavioral therapy BEHAVIORAL

The therapy will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD.

1

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of PD with no significant motor fluctuations or dementia.
• Major Depression, Dysthymia, or Depression NOS (Clinically significant depression not otherwise specified).
• years old.
• Willingness to ask a family member or friend, with whom the patient has regular contact, to be involved in treatment.
• Patients will be allowed to remain on antidepressant medications that have been stabilized (e.g., no dose changes) for at least 6 weeks prior to screening provided that they do not have plans to change these medications while in the study.
• Patients will be allowed to remain on sedative-hypnotics or anxiolytics that have been stabilized for at least 4 weeks prior to screening. Patients who are taking these medications at screening and qualify for participation will be asked to remain on a stable course of these medications throughout the trial.
• Taking a stable dose of dopaminergic replacement therapy for at least one month

You may not qualify if:

• Active suicidal ideation.
• An unstable major medical condition that would interfere with the study.
• Plans to engage in additional psychotherapy during the study (PD support group is ok).
• A diagnosis of dementia, defined as above.
• Significant motor fluctuations, defined as above; mild end of dose wearing off is allowed.
• Patients unwilling or unable to maintain a stable dose of dopaminergic replacement therapy during the trial.
• Use of mood-stabilizers or antipsychotic medication.
• Ages 25 to 85
• Daily contact with a friend, family member, or spouse with depression and PD \*MMSE \> 26 \[Mini Mental Status Exam score of greater than 26 (i.e., no signs of significant memory impairment)\].
• Active suicidal ideation
• An unstable major medical or psychiatric condition
• Evidence upon clinical interview of substance abuse/dependence

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Rutgers, Robert Wood Johnson Medical School, 675 Hoes Lane, Room D-317

Piscataway, New Jersey, 08854, United States

Location

Related Publications (6)

• Dobkin RD, Menza M, Allen LA, Gara MA, Mark MH, Tiu J, Bienfait KL, Friedman J. Cognitive-behavioral therapy for depression in Parkinson's disease: a randomized, controlled trial. Am J Psychiatry. 2011 Oct;168(10):1066-74. doi: 10.1176/appi.ajp.2011.10111669. Epub 2011 Jun 15.

  PMID: 21676990 RESULT

• Dobkin RD, Rubino JT, Allen LA, Friedman J, Gara MA, Mark MH, Menza M. Predictors of treatment response to cognitive-behavioral therapy for depression in Parkinson's disease. J Consult Clin Psychol. 2012 Aug;80(4):694-9. doi: 10.1037/a0027695. Epub 2012 Mar 12.

  PMID: 22409644 RESULT

• Dobkin RD, Menza M, Allen LA, Tiu J, Friedman J, Bienfait KL, Gara MA, Mark MH. Telephone-based cognitive-behavioral therapy for depression in Parkinson disease. J Geriatr Psychiatry Neurol. 2011 Dec;24(4):206-14. doi: 10.1177/0891988711422529.

  PMID: 22228827 RESULT

• Dobkin RD, Troster AI, Rubino JT, Allen LA, Gara MA, Mark MH, Menza M. Neuropsychological outcomes after psychosocial intervention for depression in Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2014 Winter;26(1):57-63. doi: 10.1176/appi.neuropsych.12120381.

  PMID: 24275895 RESULT

• Dobkin RD. The relationship between telephone-administered cognitive-behavioral therapy for depression and neuropsychological functioning in Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2014 Apr 1;26(2):E10-1. doi: 10.1176/appi.neuropsych.13030065.

  PMID: 24763770 RESULT

• Dobkin RD, Mann SL, Interian A, Gara MA, Menza M. Cognitive behavioral therapy improves diverse profiles of depressive symptoms in Parkinson's disease. Int J Geriatr Psychiatry. 2019 May;34(5):722-729. doi: 10.1002/gps.5077. Epub 2019 Mar 4.

  PMID: 30714202 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Roseanne Dobkin
• Organization: Rutgers- Robert Wood Johnson Medical School

dobkinro@rutgers.edu

732-235-4051

Study Officials

• Roseanne D Dobkin, PhD

  Associate Professor of Psychiatry Rutgers-Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

• Matthew Menza, MD

  Professor and Chair, Department of Psychiatry, Rutgers- Robert Wood Johnson Medical School (Primary Mentor)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 5, 2014
• Results First Posted: November 5, 2014

Record last verified: 2014-11

Locations

US (1)