Stepped Telemental Health Care Intervention for Depression

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01906476
• Collaborator: (none)
• Enrollment: 312
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.9
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

This is a randomized, controlled trial comparing telephone-cognitive behavior therapy (T-CBT) with a therapist to a "Stepped Care" intervention for depression treatment (iCBT with support from a telephone coach with the possibility of being stepped up to receiving T-CBT with a therapist).

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Stepped Care; Behavioral: Telephone Cognitive Behavior Therapy	N/A

Detailed Description

Major depressive disorder (MDD) is common, with 12-month prevalence rates estimated to be between 6.6-10.3%. While many depressed patients state they would prefer psychological treatment to pharmacotherapy, substantial barriers to care exist, including cost, practical barriers such as time constraints and transportation, emotional barriers such as stigma, decreased motivation associated with depression itself, physical disability, and lack of availability of services. Telemental health has been proposed as a method of overcoming barriers to treatment. Research has focused primarily on two formats: the telephone and the Internet. Use of the telephone as a delivery medium produces reductions in depression equivalent to face-to-face psychological treatments, while also significantly reducing attrition. However, its success in outreach can also significantly increase costs for healthcare providing organizations. Internet interventions have the potential to produce moderate gains when supported by therapist or coach via brief telephone calls or e-mail but are also less expensive than standard therapy. Developing healthcare models that integrate treatment delivery media holds the promise of harnessing the advantages of each media, while minimizing the disadvantages. Stepped care models are a potentially useful framework for achieving such an integration. The stepped care model we will test initiates treatment with a validated, guided Internet cognitive behavioral therapy program. If patients fail to respond, they will be stepped up to a validated telephone-cognitive behavior therapy (T-CBT). The stepped care model will be compared to T-CBT in a randomized trial. Patients will be recruited from primary care and treated for up to 20 weeks, or until sustained remission is achieved.

Study Design

• Study Type: Interventional
• Actual Enrollment: 312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Stepped Telemental Health Care Intervention for Depression
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stepped Care Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist	Behavioral: Stepped Care; Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist
Active Comparator: Telephone Cognitive Behavior Therapy Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).	Behavioral: Telephone Cognitive Behavior Therapy; Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).

Outcome Measures

Primary Outcome Measures

1. Depression [Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up]

   To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.

2. Cost-Effectiveness [Baseline to end of treatment]

   Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has a DSM-IV diagnosis of non-psychotic major depressive disorder (MDD) as assessed using the Mini International Neuropsychiatric Interview (MINI), plus a score of 12 or greater on the Quick Inventory of Depressive Symptomatology - Clinician Rated (QIDS-C)

• Has a phone, access to the Internet, and basic internet skills

• Is at least 18 years of age

• Is able to speak and read English

• If currently taking an antidepressant medication, participant must have been on a stable dose for at least two weeks, and have no plans to change the dose

Exclusion Criteria:

• Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures

• Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use or other diagnosis for which participation in this trial is either inappropriate or dangerous

• Is severely suicidal (has ideation, plan, and intent)

• Is currently receiving or planning to begin psychotherapy during the study treatment period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: David C Mohr, Ph.D., Northwestern University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 28, 2020

More Information

Publications

None provided.

• Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
• ClinicalTrials.gov Identifier: NCT01906476
• Other Study ID Numbers: R01MH095753-01A1-RCTTH; R01MH095753-01A1
• First Posted: Jul 24, 2013
• Last Update Posted: Apr 2, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University: Depression; Telephone Cognitive Behavior Therapy; Internet Cognitive Behavioral Therapy
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Stepped Care	Telephone Cognitive Behavior Therapy
Arm/Group Description	Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist	Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Period Title: Overall Study
STARTED	157	155
COMPLETED	140	139
NOT COMPLETED	17	16

Baseline Characteristics

Arm/Group Title	Stepped Care	Telephone Cognitive Behavior Therapy	Total
Arm/Group Description	Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist	Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).	Total of all reporting groups
Overall Participants	157	155	312
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	33	32	33
Sex: Female, Male (Count of Participants)
Female	118 75.2%	111 71.6%	229 73.4%
Male	37 23.6%	44 28.4%	81 26%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 7.6%	20 12.9%	32 10.3%
Not Hispanic or Latino	141 89.8%	134 86.5%	275 88.1%
Unknown or Not Reported	4 2.5%	1 0.6%	5 1.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 1.3%	2 0.6%
Asian	5 3.2%	6 3.9%	11 3.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 3.2%	9 5.8%	14 4.5%
White	135 86%	130 83.9%	265 84.9%
More than one race	7 4.5%	5 3.2%	12 3.8%
Unknown or Not Reported	5 3.2%	3 1.9%	8 2.6%
Baseline QIDS (Quick Inventory of Depressive Symptomatology) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	14	14	14
PHQ-9 (Patient Health Questionnaire 9) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	16	17	16

Outcome Measures

1. Primary Outcome

Title	Depression
Description	To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.
Time Frame	Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up

Outcome Measure Data

Analysis Population Description

Participants with at least one followup visit which recorded the QIDS post baseline

Arm/Group Title	Stepped Care	Telephone Cognitive Behavior Therapy
Arm/Group Description	Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist	Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Measure Participants	134	136
Midtreatment	10.51 (0.40)	11.22 (0.39)
End of Treatment	7.84 (0.38)	7.71 (0.37)
Month 3 (post treatment)	7.78 (0.42)	7.88 (0.40)
Month 6 (post treatment)	7.89 (0.44)	8.24 (0.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care, Telephone Cognitive Behavior Therapy
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority trials of pharmaceuticals have used 30% to 50% of the difference between treatment and control conditions to define non-inferiority margins. (Jones, Jarvis, Lewis, & Ebbutt, 1996; Nutt et al., 2008). A meta-analysis of CBT found an overall effect size of d=0.82.(Cuijpers, Smit, Bohlmeijer, Hollon, & Andersson, 2010). Using the midpoint of 40% for the acceptable criterion, we set d=0.33 as the non-inferiority criterion.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		Cohen's d and upper limits of one-sided 95% Confidence intervals for each time are as follows: Mid-treatment -0.19 (95% upper limit= 0.06) End of treatment 0.03 (0.24) 3 months post treatment -0.02 (0.19) 6 months post treatment -0.07 (0.14)

2. Primary Outcome

Title	Cost-Effectiveness
Description	Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study.
Time Frame	Baseline to end of treatment

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	Stepped Care	Telephone Cognitive Behavior Therapy
Arm/Group Description	Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist	Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
Measure Participants	157	155
Mean (Standard Deviation) [dollars]	391.81 (229.06)	756.14 (298.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care, Telephone Cognitive Behavior Therapy
	Comments	We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	ICER estimate
	Estimated Value	-152.55
	Confidence Interval	(2-Sided) 95%; -1143.09 to 1094.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline through 6 month post-treatment followup
Arm/Group Title	Stepped Care		Telephone Cognitive Behavior Therapy
Arm/Group Description	Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist Stepped Care: Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist		Participants will receive telephone-administered cognitive behavioral therapy (T-CBT). Telephone Cognitive Behavior Therapy: Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
All Cause Mortality
	Stepped Care		Telephone Cognitive Behavior Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/155 (0%)
Serious Adverse Events
	Stepped Care		Telephone Cognitive Behavior Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/155 (0%)
Other (Not Including Serious) Adverse Events
	Stepped Care		Telephone Cognitive Behavior Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/155 (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.