Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00218634
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 89
• Location: 1
• Arms: 2
• Duration (Months): 52.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Patients with HIV, depression, and opioid-dependence are at high risk for poor health outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for depression and HIV medication adherence in patients with opioid dependence who are receiving methadone maintenance treatment. The project is based on our pilot work with close attention to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et al., 2001).

Depression is highly comorbid with both HIV infection and with opioid dependence. Depression and substance abuse are both associated with poor adherence to antiretroviral medications. Patients with HIV, depression, and opioid dependence are at high risk for poor health outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious psychosocial intervention for depression; and research by the PI and others has shown that cognitive-behavioral interventions have been successful in promoting adherence to HIV medications.

Condition or Disease	Intervention/Treatment	Phase
Adherence; Depression; Heroin Dependence; Methadone; Motivational Interviewing; Substance-Related Disorders	Behavioral: CBT-AD; Behavioral: ETAU	N/A

Detailed Description

Symptoms of depression (i.e. low motivation, poor concentration, loss of interest, sad mood, suicidal ideation) that occur in the context of substance abuse or dependence can interfere with self-care behaviors necessary for maintaining HIV care, as well as interfere with potential benefit from an intervention that focuses on adherence alone. We hypothesize that teaching skills to cope with depression will improve the outcome from an adherence intervention to promote healthier living with HIV, in HIV+ opioid dependent individuals in methadone maintenance treatment.

Overview of Research Plan. Patients who are HIV positive and who are receiving methadone maintenance for opioid dependence will be randomized to treatment with either: (1) CBT, a combination of CBT for depression and HIV medication adherence, including a single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments or (2) the single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments. Participants will be followed for one-year post-randomization.

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: CBT for Depression & Adherence in HIV Methadone Patients
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBT-AD Cognitive behavioral therapy for adherence and depression	Behavioral: CBT-AD; Cognitive behavioral therapy for adherence and depression consisting of 1 session focusing on adherence and 8 sessions consisting of cognitive behavioral therapy for medication adherence and depression.
Active Comparator: ETAU Enhanced treatment as usual	Behavioral: ETAU; Enhanced treatment as usual consisting of 1 session focused on adherence (the same session as the CBT-AD intervention) and 8 sessions for participants to complete self-reports and collect adherence data.

Outcome Measures

Primary Outcome Measures

1. Percent Medication Adherence at 3-month Follow-up Assessment [3-month assessment]

   Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.

2. Percent Medication Adherence at 12-month Follow-up Assessment [12-month follow-up assessment]

   Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.

Secondary Outcome Measures

1. Clinician-assessed Depression Rating at 3 Month Follow-up Assessment [3 month follow-up]

   Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.

2. HIV Viral Load at 12-month Follow-up Assessment [12-month follow-up assessment]

   HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.

3. CD4+ Lymphocyte Count at 12-month Follow-up Assessment. [12-month follow-up assessment]

   CD4+ lymphocyte cell count at 12-month follow-up assessment.

4. Clinician-assessed Depression at 12-month Follow-up Assessment [12-month follow-up assessment]

   Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.

5. HIV Viral Load at 3-month Follow-up Assessment [3-month assessment]

   HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.

6. CD4+ Lymphocyte Count at 3-month Follow-up Assessment. [3-month assessment]

   CD4+ lymphocyte cell count at 3-month follow-up assessment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HIV seropositive

• Currently enrolled in methadone maintenance treatment for at least one month

• Current major or subsyndromal depression (subsyndromal depression is defined by major depression that does not meet full diagnostic criteria but with a clinical global impression of severity (CGI-S) of 2 (mildly ill))

• Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.

• Between the ages of 18 and 65.

Exclusion Criteria:

• Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania), or other Axis I psychiatric disorders (other than depression) that would interfere with the ability to participate (i.e. CGI-S >6)

• Unable or unwilling to provide informed consent.

• Currently in cognitive behavioral therapy for depression.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Steven Safren, Ph.D., Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00218634
• Other Study ID Numbers: NIDA-18603-1; R01DA018603
• First Posted: Sep 22, 2005
• Last Update Posted: Jan 2, 2018
• Last Verified: Dec 1, 2017

• Additional relevant MeSH terms: Substance-Related Disorders; Heroin Dependence; Depression; Depressive Disorder

Study Results

Participant Flow

Recruitment Details	First participants from methadone clinics, remainder from MGH or RIH clinics.
Pre-assignment Detail	Participants had to screen for study inclusion/exclusion criteria before randomization.

Arm/Group Title	CBT-AD	ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced Treatment as Usual
Period Title: Overall Study
STARTED	44	45
COMPLETED	36	30
NOT COMPLETED	8	15

Baseline Characteristics

Arm/Group Title	CBT-AD	ETAU	Total
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced Treatment as Usual	Total of all reporting groups
Overall Participants	44	45	89
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	44 100%	45 100%	89 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.05 (7.34)	46.67 (7.05)	46.85 (7.15)
Sex: Female, Male (Count of Participants)
Female	17 38.6%	18 40%	35 39.3%
Male	27 61.4%	27 60%	54 60.7%
Region of Enrollment (participants) [Number]
United States	44 100%	45 100%	89 100%

Outcome Measures

1. Primary Outcome

Title	Percent Medication Adherence at 3-month Follow-up Assessment
Description	Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.
Time Frame	3-month assessment

Outcome Measure Data

Analysis Population Description

We used hierarchical linear modeling (HLM) methods and intent to treat for all randomized participants.

Arm/Group Title	CBT-AD	ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced treatment as usual
Measure Participants	44	45
Mean (Standard Deviation) [percent (doses taken/doses prescribed)]	79.02 (23.23)	73.66 (25.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CBT-AD, ETAU
	Comments	We used HLM with weekly visit data for the acute outcome. There were, therefore, 11 time points used.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments
	Method	HLM
	Comments

2. Secondary Outcome

Title	Clinician-assessed Depression Rating at 3 Month Follow-up Assessment
Description	Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.
Time Frame	3 month follow-up

Outcome Measure Data

Analysis Population Description

We used intent to treat for all data analysis.

Arm/Group Title	Cognitive Behavioral Therapy for Adherence and Depression	Enhanced Treatment as Usual
Arm/Group Description	Cognitive behavioral therapy focusing on treating depression and adherence to medication (CBT-AD).	Enhanced treatment as usual (ETAU).
Measure Participants	44	45
Mean (Standard Deviation) [Units on scale]	17.02 (10.62)	22.7 (10.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CBT-AD, ETAU
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments	GLM - CBT-AD would be superior to ETAU at post. HLM - CBT-AD would be superior to CBT-AD at follow ups.
	Method	GLM and HLM
	Comments

3. Secondary Outcome

Title	HIV Viral Load at 12-month Follow-up Assessment
Description	HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.
Time Frame	12-month follow-up assessment

Outcome Measure Data

Analysis Population Description

We used intent to treat for all data analysis.

Arm/Group Title	CBT-AD	ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced treatment as usual
Measure Participants	44	45
Log Mean (Standard Deviation) [log10 copies/mL]	2.203 (0.687)	2.177 (0.820)

4. Secondary Outcome

Title	CD4+ Lymphocyte Count at 12-month Follow-up Assessment.
Description	CD4+ lymphocyte cell count at 12-month follow-up assessment.
Time Frame	12-month follow-up assessment

Outcome Measure Data

Analysis Population Description

We used intent to treat for all data analysis.

Arm/Group Title	CBT-AD	ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced treatment as usual
Measure Participants	44	45
Mean (Standard Deviation) [cells/mm^3]	452.94 (235.00)	502.33 (314.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CBT-AD, ETAU
	Comments	follow up analysis revealed that CD4, over time, significantly improved over control when covarying out baseline levels.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.05
	Comments	CD4 would be more improved in the treatment condition
	Method	HLM
	Comments

5. Primary Outcome

Title	Percent Medication Adherence at 12-month Follow-up Assessment
Description	Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.
Time Frame	12-month follow-up assessment

Outcome Measure Data

Analysis Population Description

We used intent to treat for all data analysis.

Arm/Group Title	CBT-AD	ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced Treatment as Usual
Measure Participants	44	45
Mean (Standard Deviation) [percent (doses taken/doses prescribed)]	64.49 (31.34)	61.11 (34.94)

6. Secondary Outcome

Title	Clinician-assessed Depression at 12-month Follow-up Assessment
Description	Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.
Time Frame	12-month follow-up assessment

Outcome Measure Data

Analysis Population Description

We used intent to treat for all data analysis.

Arm/Group Title	CBT-AD	ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced Treatment as Usual
Measure Participants	44	45
Mean (Standard Deviation) [Units on scale]	15.28 (9.22)	20.00 (10.97)

7. Secondary Outcome

Title	HIV Viral Load at 3-month Follow-up Assessment
Description	HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.
Time Frame	3-month assessment

Outcome Measure Data

Analysis Population Description

We used intent to treat for all data analysis.

Arm/Group Title	CBT-AD	ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced Treatment as Usual
Measure Participants	44	45
Mean (Standard Deviation) [log10 copies/mL"]	2.349 (0.928)	2.044 (0.509)

8. Secondary Outcome

Title	CD4+ Lymphocyte Count at 3-month Follow-up Assessment.
Description	CD4+ lymphocyte cell count at 3-month follow-up assessment.
Time Frame	3-month assessment

Outcome Measure Data

Analysis Population Description

We used intent to treat for all analysis.

Arm/Group Title	CBT-AD	ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression	Enhanced Treatment as Usual
Measure Participants	44	45
Mean (Standard Deviation) [cells/mm3]	380.97 (266.62)	539.29 (293.61)

Adverse Events

Time Frame	Adverse events are reported for a given participant for the time that participant was enrolled in the trial (roughly 1 year).
Adverse Event Reporting Description	Serious adverse events reported include those that were study related.
Arm/Group Title	CBT-AD		ETAU
Arm/Group Description	Cognitive behavioral therapy for adherence and depression		Enhanced Treatment as Usual
All Cause Mortality
	CBT-AD		ETAU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CBT-AD		ETAU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	CBT-AD		ETAU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.