Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02498132

Enrollment

Registered

2015-07-15

Start date

2016-06-01

Completion date

2016-12-31

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Mobile Technologies

Brief summary

Elevated depressive symptomatology is a widespread public health concern and individuals with elevated depressive symptoms most frequently report such symptoms to primary care physicians (PCPs). PCPs have few evidence-based resources beyond antidepressant medication for treating elevated depressive symptoms, which results in negative outcomes for their depressed patients. Mobile technologies offer an ideal strategy to meet widespread treatment needs. The purpose of the proposed project is to\\ customize Behavioral Activation (BA), a straightforward, empirically supported treatment for elevated depressive symptoms, for a mobile format (Moodivate) in order to address the currently unmet needs of PCPs and their patients with elevated depressive symptoms.

Detailed description

Depressive symptoms are associated with heightened risk of developing major depressive disorder (MDD), significant public health costs, and mortality rates equal to MDD . Individuals experiencing impairment due to depressive symptomatology most frequently report their depressive symptoms to a primary care physician . Despite conflicting data regarding efficacy, PCPs typically prescribe antidepressant medication for the treatment of subthreshold depression and have few other resources at their disposal . The current lack of evidence-based resources available to PCPs for treating depressive symptoms results in a number of negative outcomes for patients including: 1) the majority not receiving appropriate treatment , 2) a decreased likelihood of reporting depressive symptoms again in the future , and 3) heightened mortality risk. As the most likely initial contact for patients with elevated depressive symptoms, PCPs are in a unique position to provide interventions for depression . Mobile technologies offer an ideal strategy to meet widespread treatment needs. Mobile technologies broadly, and mobile phones more specifically, have dramatically increased in both affordability and ubiquity, with current estimates suggesting that there are over 3.2 billion unique mobile users worldwide . Moreover, the vast majority of physicians report using mobile apps in their clinical practice . Despite these factors supporting the use of mobile apps in clinical practice, there are currently no mobile apps for depressive symptoms available to PCPs that are both evidence-based and simple enough to be recommended to their patients. One treatment that is particularly amenable to a mobile platform and to referral by PCPs is Behavioral Activation. Across studies, BA is effective for reducing depressive symptoms among individuals with subthreshold depression as well as individuals with MDD and meets the criteria to be established as an empirically support treatment . Moreover, numerous research studies support the superiority of BA as a treatment component to competitor treatments, including Cognitive Behavioral Therapy (CBT) and Cognitive Therapy (CT). The cornerstone of BA is regular self-monitoring to 1) examine already occurring daily activities and 2) facilitate incorporation of new activities consistent with individualized values and goals across life areas. Empirical evidence indicates that mobile customization of BA would work as intended to facilitate reduction of depressive symptomatology, while also addressing the unmet need for evidence-based and easily disseminable resources for use by PCPs with their patients with depressive symptomatology. Moreover, as BA has an evidence-base for smoking cessation, a mobile customization of BA may also hold promise for promoting smoking cessation. With STTR funding from NIMH, our team is currently completing the development of a self-help BA mobile application named Moodivate for referral by PCPs to their patients with elevated depressive symptoms. App development will be complete by March, 2016 in preparation for a small clinical trial at MUSC. The closest competitor apps for Moodivate are Cognitive Behavioral Therapy (CBT)-based mobile applications. The most popular CBT-based mobile applications include iCouch CBT, Live Happy, MoodPanda, and MoodKit. Of this group of CBT-based mobile applications, MoodKit most closely adheres to standard CBT. As clinical trials of standard BATD frequently compare BATD to CBT, an appropriate analogue of this line of work is to compare Moodivate, a BATD based mobile app, to MoodKit, a CBT based mobile app. Although MoodKit appears to adhere to CBT, no clinical trials to date have been completed examining utilization of MoodKit among individuals with elevated depressive symptoms or among individuals referred by a PCP. In the current study, we will conduct a small-scale randomized clinical trial with 60 adults with elevated depressive symptoms (Beck Depression Inventory-II (BDI-II) \> 14; above the minimal depression range on the measure) referred from physicians in the Department of Family Medicine (Drs. Vanessa Diaz and Marty Player) at MUSC. Participants will be randomized to one of three conditions: 1) Moodivate, 2) a Cognitive Behavioral Therapy-based mobile application (MoodKit), or 3) Treatment As Usual (TAU). The purpose of this step is to examine Moodivate treatment feasibility, acceptability, adherence, and change in depressive symptoms associated with Moodivate as compared to MoodKit and TAU. Considering that BA also has an evidence base for smoking cessation, within this group of 60 participants, we plan to recruit 10 participants who are current smokers who will receive Moodivate. Although this will be a small sample of smokers receiving the BA mobile therapy, we believe collecting pilot data examining utilization of Moodivate among a group of smokers will provide valuable insight into the feasibility of utilizing a BA mobile app to promote smoking cessation.

Interventions

OTHERBehavioral Activation

BA is based in behavioral principles of depression that suggest that depression is caused by a lack of reinforcement in the environment for positive, non-depressed behaviors. As such, the goal of BA is to help the patient reengage in positive, non-depressed activities. In clinical trials, BA as a treatment component has been consistently superior to no treatment and treatment as usual control groups, and a large body of research has found that BA is either equally or more effective than CBT, CT, and antidepressant medications (Cuijpers, Van Straten, & Warmerdam, 2007; Dimidjian et al., 2006; Jacobson et al., 1996).

OTHERCognitvie Based Therapy

CBT explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts, people with mental illness can modify their patterns of thinking to improve coping

OTHERTreatment as Usual

Individuals will be provided with one on one therapy sessions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Participants will be screened by phone. Inclusion criteria: Participants must: 1. be between the ages of 18 and 65, 2. report current elevated depressive symptoms, and 3. currently own an iOS-compatible mobile phone.

Exclusion criteria

Participants will be excluded if they: 1. are currently receiving psychotherapy or psychotropic medication, 2. plan to seek psychotherapy within the next 3 months (score \> 5 on a self-report 1-10 scale of likelihood to seek treatment), 3. endorse current suicidal ideation defined as either 1. a response of I would like to kill myself or I would kill myself if I had the chance on the suicidal thoughts or wishes item of the BDI-II or 2. an indication of past month suicidal ideation on the MDD module of the SCID-IV (see Protection of Human Subjects for additional details), or 4. meet current diagnostic criteria for MDD; although BA has been used to treat MDD, Moodivate is targeted specifically to elevated symptoms, not major depressive episodes.

Design outcomes

Primary

Measure	Time frame	Description
Average Decrease of Beck Depression Inventory-II Score	Baseline and Week 8	The BDI-II is a well-validated tool for the assessment of depressive symptoms and is our key outcome measure. For assessing weekly changes in mood, we will use the Profile of Mood States, a brief self-report scale that has demonstrated satisfactory psychometric properties. For MDD diagnosis, during the phone screening, participants will complete a shortened version of the MDD module of the Structured Clinical Interview for the DSM-IV. The scale for the Beck's Depression Inventory is 0-63 where higher scores indicate more severe depressive symptoms. Scores were analyzed as a 10 point decrease from baseline at any point in the study. For pretreatment, participants completed the BDI-II at baseline and for posttreatment, participants completed the BDI-II 8 weeks after baseline. Values were calculated by subtracting pretreatment from posttreatment and averaging across participants, within treatment condition.

Secondary

Measure	Time frame	Description
Changes Among User Feasibility and Acceptability	Once a week for 8 weeks	User feasibility and acceptability will be assessed both during and following the 8 weeks of Moodivate or MoodKit treatment. During the course of Moodivate or MoodKit treatment, users will be prompted at random intervals to respond to a brief survey online assessing: 1) ease of use of the product, 2) continued desire to use the product, 3) perceived benefits of using the product, and 4) suggestions for product development/modifications for Behavioral Apptivation only). Following the 8 weeks of treatment, participants who were randomized to the Moodivate condition will attend a phone call with the Invesitgator at the Medical University of South Carolina.
Positive and Negative Affect Schedule (PANAS)	Once a week for 8 weeks	Participants completing the PANAS are asked to rate the extent to which they experienced each out of 20 emotions on a 5-point Likert Scale ranging from very slightly to very much. The exact instructions may vary according to the purpose of the study: Participants may be asked how they feel right now or during longer periods of time (e.g. during the past year). Half of the presented emotion words concern negative affect (distressed, upset, guilty, ashamed, hostile, irritable, nervous, jittery, scared, afraid), the other half positive affect (interested, alert, attentive, excited, enthusiastic, inspired, proud, determined, strong, active). The PANAS is usually regarded as a reliable measure for non-clinical populations
EROS ( Emotion Regulation of Others and Self)	Once a week for 8 weeks	Assesses strategies used to improve and worsen both one's own and others' emotions. It has two subscales. The intrinsic subscale measures emotion self-regulation using 10 items. The extrinsic subscale measures interpersonal emotion regulation using 9 items.
Profile of Mood States (POMS)	Once a week for 8 weeks	Measures affective mood states
Behavioral Activation for Depression Scale (BADS)	Once a week for 8 weeks	The Behavioral Activation for Depression Scale (BADS) can be used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. It examines changes in the following areas: activation, avoidance/rumination, work/school impairment, and social impairment.
Client Treatment Adherence	Once a week for 8 weeks	Client treatment adherence will be measured based on the activity selection and scheduling component of Moodivate.
Beck Anxiety Inventory (BAI)	Once a week for 8 weeks	21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults
The Addiction Severity Index (ASI) i	Once a week for 8 weeks	The Addiction Severity Index (ASI) is a semi-structured interview for substance abuse assessment and treatment planning. The ASI is designed to gather valuable information about areas of a client's life that may contribute to their substance-abuse problems.
Fagerstrom Test For Nicotine Dependence (FTND)	Once a week for 8 weeks	The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.
Timeline Followback Method Assessment	Once a week for 8 weeks	The Timeline Followback (TLFB) is a method that can be used as a clinical and research tool to obtain a variety of quantitative estimates of marijuana, cigarette, and other drug use.
Contemplation Ladder	Once a week for 8 weeks	A measure of readiness to consider smoking cessation
Snaith-Hamilton Pleasure Scale (SHAPS)	Once a week for 8 weeks	Assesses anhedonia a core symptom in depression

Participant flow

Participants by arm

Arm	Count
Behavioral Activation Behavioral Activation will be administered via Moodivate and will include the following core BA components: (1) psychoeducation, (2) development of individualized values and value-drive activities, (3) scheduling and completing activities, (4) eliciting social support to help complete difficult activities, and (5) rating daily mood and reinforcing treatment utilization. Moodivate will also be modified for a mobile environment in key ways, with the most salient being: 1) Elimination of the need for a therapist in order to reach a broad patient/consumer base that may not utilize traditional therapy resources and will combat the primary barrier to PCPs recommending psychotherapy to their patients with elevated depressive symptoms and 2) Elimination of paper forms to increase the sensitivity of BA for individuals with motivational and organizational deficits.	24
Cognitive Behavioral Therapy Moodkit (a mobile app utilizing Cognitive Behavioral Therapy techniques) will be used to administer cognitive behavioral therapy which is commonly compared to behavioral activation. Cognitive Behavioral Therapy (CBT) explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts. CBT is an evidence-based approach for reducing depression.	19
Treatment as Usual TAU will be provided to individuals. These subject will be provided with therapy but will not utilize a mobile application. Treatment as Usual: Individuals will be provided with one on one therapy sessions	9
Total	52

Baseline characteristics

Characteristic	Cognitive Behavioral Therapy	Treatment as Usual	Behavioral Activation	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	19 Participants	9 Participants	24 Participants	52 Participants
Age, Continuous	43.00 years STANDARD_DEVIATION 13.63	43.11 years STANDARD_DEVIATION 11.88	44.67 years STANDARD_DEVIATION 13.95	43.79 years STANDARD_DEVIATION 13.27
Annual Household Income < $50k	13 Participants	6 Participants	13 Participants	32 Participants
Annual Household Income ≥ $50k	6 Participants	3 Participants	11 Participants	20 Participants
Currently Taking Medication for Mental/Emotional Problems No	12 Participants	6 Participants	15 Participants	33 Participants
Currently Taking Medication for Mental/Emotional Problems Yes	7 Participants	3 Participants	9 Participants	19 Participants
Current Major Depressive Episode No	5 Participants	3 Participants	7 Participants	15 Participants
Current Major Depressive Episode Yes	14 Participants	6 Participants	17 Participants	37 Participants
Education ≤ High School Diploma	4 Participants	2 Participants	2 Participants	8 Participants
Education ≥ High School Diploma	15 Participants	7 Participants	22 Participants	44 Participants
Employment Status Employed ≥ part time	11 Participants	7 Participants	13 Participants	31 Participants
Employment Status Other	6 Participants	0 Participants	8 Participants	14 Participants
Employment Status Unemployed	2 Participants	2 Participants	3 Participants	7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	0 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants	9 Participants	24 Participants	50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Lifetime Major Depressive Episode No	2 Participants	0 Participants	1 Participants	3 Participants
Lifetime Major Depressive Episode Yes	17 Participants	9 Participants	23 Participants	49 Participants
Phone Ownership Android or other smartphone	11 Participants	6 Participants	12 Participants	29 Participants
Phone Ownership iPhone	8 Participants	3 Participants	12 Participants	23 Participants
Region of Enrollment United States	19 participants	9 participants	24 participants	52 participants
Relationship Status In a relationship	7 Participants	4 Participants	8 Participants	19 Participants
Relationship Status Single	12 Participants	5 Participants	16 Participants	33 Participants
Sex: Female, Male Female	15 Participants	8 Participants	20 Participants	43 Participants
Sex: Female, Male Male	4 Participants	1 Participants	4 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 24	0 / 19	0 / 9
other Total, other adverse events	0 / 24	0 / 19	0 / 9
serious Total, serious adverse events	0 / 24	0 / 19	0 / 9

Outcome results

Primary

Average Decrease of Beck Depression Inventory-II Score

The BDI-II is a well-validated tool for the assessment of depressive symptoms and is our key outcome measure. For assessing weekly changes in mood, we will use the Profile of Mood States, a brief self-report scale that has demonstrated satisfactory psychometric properties. For MDD diagnosis, during the phone screening, participants will complete a shortened version of the MDD module of the Structured Clinical Interview for the DSM-IV. The scale for the Beck's Depression Inventory is 0-63 where higher scores indicate more severe depressive symptoms. Scores were analyzed as a 10 point decrease from baseline at any point in the study. For pretreatment, participants completed the BDI-II at baseline and for posttreatment, participants completed the BDI-II 8 weeks after baseline. Values were calculated by subtracting pretreatment from posttreatment and averaging across participants, within treatment condition.

Time frame: Baseline and Week 8

Population: For pretreatment, participants completed the BDI-II at baseline and for posttreatment, participants completed the BDI-II 8 weeks after baseline.

Arm	Measure	Value (MEAN)	Dispersion
Behavioral Activation	Average Decrease of Beck Depression Inventory-II Score	-12.21 Decrease in units on scale	Standard Deviation 13.15
Cognitive Behavioral Therapy	Average Decrease of Beck Depression Inventory-II Score	-13.36 Decrease in units on scale	Standard Deviation 11.51
Treatment as Usual	Average Decrease of Beck Depression Inventory-II Score	-7.75 Decrease in units on scale	Standard Deviation 14.99

p-value: <0.05Chi-squared

Secondary

Beck Anxiety Inventory (BAI)

21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults