Effectiveness of Group Versus Individual Self-management of Depression Using a Mobile App to Increase Treatment Adherence Among Users of a University-based Helpline in the Dominican Republic.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Northern Illinois University
- Enrollment
- 27
- Locations
- 3
- Primary Endpoint
- Change in NIH Toolbox Emotional Support Scale score
Study Overview
Brief Summary
The overall objective of this study is to develop a feasible and acceptable mental health app which delivers Cognitive Behavioral Therapy (CBT) for depressed patients in the Dominican Republic. This proposal meets the research objectives of NIMH in delivering mental health care to populations with low literacy, and supporting health care systems in monitoring and improving the quality of mental health. In the proposed study, the investigators will upgrade, implement, and evaluate a depression treatment app and assess trained facilitators' capacity in managing participants' depression symptoms using the app. The investigators will conduct a randomized controlled trial (RCT) among 120 participants who screen positive for mild to moderate depression or anxiety on the Patient Health Questionnaire (PHQ-9) or GAD- 7 via a university-based Covid mental health hotline. The app, El Buen Consejo Móvil (EBCM), will be downloaded to the participants' own Android phone. Participants will be randomized to receive the EBCM app with the functionality to connect individuals to one another via a facilitator-guided chat room (ECBM-G; n= 60) or to receive the same contents as an individualized facilitator-guided CBT program without the group functionality (ECBM-I; n=60).
Recruitment and mixed-methods data collection will be conducted by phone, given current circumstances surrounding the Covid-19 pandemic. Process outcomes will be evaluated for the trained facilitators. The primary outcomes for app users will be acceptability of the app and perceptions of social interactivity for those randomized to the group condition. Validated questionnaires will be administered to measure perceived emotional support, loneliness, and interactivity. Level of adherence and effectiveness, the secondary outcomes, will be assessed by frequency of interaction with the app, completion of treatment for either treatment modality, and change in depressive symptoms.
The investigators hypothesize that the use of the app for guided self-help can be enhanced through group interaction. EBCM can result in increased access to care in low-income community settings where patients are not currently receiving treatment due to logistical barriers and the stigma of seeking care in a mental health care setting.
Detailed Description
Study design:
The investigators will implement an Optimization, Effectiveness and Implementation (OEI) Hybrid Trial, based upon preliminary work. During the first six months, the investigators will upgrade and modify the mental health app, EBCM, to improve the interface and user friendliness.
Aim 1 (Optimization): Investigators will integrate app enrollment within a mental health hotline staffed by research assistants who are licensed psychologists. Protocols will be developed and produced for all hotline volunteers, including depression screening, evaluation and criteria for referral, and recruitment of individuals for study participation. Facilitators will receive extensive training for encouraging and guiding participants in usage of the app, and for facilitating chat rooms among the EBCM-G study arm. Process outcomes assessed among the app facilitators will include 1) feasibility, 2) fidelity, 3) acceptability of the training, and 4) perceived confidence in identifying and managing patients' symptoms of depression.
Aim 2 (Effectiveness and Implementation): Investigators will conduct an RCT with 120 participants who will be randomized to receive either the group treatment modality (El Buen Consejo Móvil-Group; EBCM-G) or the individual treatment modality (El Buen Consejo Móvil-Individual; EBCM-I). Participants will be followed for the duration of the 6-week intervention. Participants randomized to EBCM-G will be placed in groups of five participants within the app. Their version of the app will have the functionality to connect individuals to one another via a facilitator-guided chat room where they may respond to suggested strategies within the app and communicate with each other or their facilitator using voice or text. Participants randomized to EBCM-I will receive the same program contents without the group functionality.
Procedures:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in NIH Toolbox Emotional Support Scale score
Time Frame: At Baseline (0 weeks) and at six weeks
Participants' perceived emotional support will be assessed at baseline (pre-intervention) and endline (post-intervention). Emotional support will be measured using the 8-item emotional support sub-scale from the validated Spanish version of the NIH Toolbox Social Relationship Scales. This sub-scale includes items related to having someone available with whom to discuss problems and who may provide empathy, support, and suggestions. The alpha coefficient of reliability for the emotional support sub-scale is 0.969. Participants rate the eight items on a five-point frequency scale (1-Never; 2-Rarely; 3-Sometimes; 4-Usually; 5-Always) over a past-month time frame. Scores may range from 8 to 40, with higher scores indicating greater levels of emotional support.
Adapted Depression Training Program Evaluation (DTPE)
Time Frame: Through study completion; 18 months
The facilitators' impressions of the training and the app itself will be assessed through the administration of an adapted version of the Depression Training Program Evaluation (DTPE) at the end of the intervention period. Based on the Hartford Foundation's nurse depression training program, this tool assesses feasibility of implementation, perceived acceptability of the training, perceived changes in knowledge level and confidence in one's ability to identify and manage participants' depressive symptoms, perceived changes in confidence in one's ability to communicate with participants, and perceived outcomes of the intervention for participants. In the present study, the adapted data collection instrument includes both close-ended Likert-scale rating questions as well as open-ended questions with probes.
Adapted Computer-Mediated Communication Questionnaire (CMCQ)
Time Frame: An average of six weeks
Participants' perceptions of acceptability and social interactivity of the app will be assessed a second time at endline (immediately after the end of the 6-week intervention) through close-ended rating scale questions derived from the Computer-Mediated Communication Questionnaire (CMCQ). The CMCQ measures attitudes towards tech-mediated communication, consisting of four domains: social context, privacy, interactivity, and online communication (alpha coefficient of reliability = 0.83). In the present study, the adapted questions will explore these domains as they relate to app contents, engagement, mood states while using the app, and barriers and facilitators to app use. Follow-up open-ended questions will be administered to a sub-set of at least 15 participants at endline; it is anticipated that this qualitative data will provide context for interpreting the quantitative data.
Adherence
Time Frame: Week 6
Participant adherence to EBCM by ascertainment of number of sessions with participation (either voice or text response) divided by maximum number of sessions (60)
Change in Three-Item Loneliness Scale score
Time Frame: At Baseline (0 weeks) and at 6 weeks
Participants' perceived loneliness will be assessed at baseline (pre-intervention) and endline (post-intervention). Perceived loneliness will be measured through the Three-item Loneliness Scale, which was derived from the R-UCLA Loneliness Scale with the goal of providing a measure that is easy to administer through telephone surveys. The Three-item Loneliness Scale has high internal consistency and an alpha coefficient of reliability of 0.72. Participants respond to three questions about perceived loneliness using a three-point frequency scale (1-Hardly ever; 2-Some of the time; and 3-Often). Scores may range from 3 to 9, with higher scores indicating greater perceived loneliness.
Secondary Outcomes
- Internet-delivered Cognitive Behavior Therapy - Therapist Rating Scale (ICBT-TRS)(Intervention Weeks 1-6)
- Change in Patient Health Questionnaire (PHQ-9) score(Baseline - 0 weeks and at Week 6)
- Measure of Staff/Patient interaction scale(At six weeks)