Trial Outcomes & Findings for Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems (NCT NCT02498132)

Last Updated: 2023-11-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2023-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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
Overall Study STARTED	24	19	9
Overall Study COMPLETED	22	18	9
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 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.