Connect ME: Improving Social Connectedness | NCT05686681 | Trialant

Connect ME: Improving Social Connectedness | NCT05686681 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brief Behavioral Activation for Improving Social Connectedness	Experimental	Active, 6 session Brief Behavioral Activation for Improving Social Connectedness	Behavioral: Brief Behavioral Activation for Improving Social Connectedness

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brief Behavioral Activation for Improving Social Connectedness	Behavioral	Brief Behavioral Activation for Improving Social Connectedness (BBAISC): BBAISC was developed to address social connectedness. Grounded in Behavioral Activation (Lejuez et al., 2011), BBAISC is a structured, 6-session skill-building intervention that has 4 key elements (Pepin et al., 2020): Psychoeducation: Psychoeducation focused on homebound status, social connectedness, and associated changes in behavior. Behavioral Activation intervention rationale: Framing how changing behavior can positively impact social connectedness (i.e., improve social connectedness and reduce loneliness). Exploration of life areas, values, and activities: Focused on identifying life areas and values most relevant to the participant. Then, these values are used to generate activities that are aligned with those values. Activity monitoring and planning: Participants are encouraged to schedule and organize their day based on what is important rather than their current mood or feeling state.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Social Connectedness A, Baseline	10-item Duke Social Support Index (DSSI)	before the intervention
Social Connectedness A, Change from Baseline to Post Intervention	10-item Duke Social Support Index (DSSI)	immediately following the intervention
Social Connectedness A, Change from Post Intervention to Follow Up	10-item Duke Social Support Index (DSSI)	12 weeks post intervention
Social Connectedness B, Baseline	8-item PROMIS Social Isolation Scale	before the intervention
Social Connectedness B, Change from Baseline to Post Intervention	8-item PROMIS Social Isolation Scale	immediately following the intervention
Social Connectedness B, Change from Post Intervention to Follow Up	8-item PROMIS Social Isolation Scale	12 weeks post-intervention

Contacts/Locations Module