Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

Phase 2

Completed

Interventions: Behavioral: Motivational Interviewing
Behavioral: Healthy Lifestyles Education

Brief Summary: The purpose of this study is to evaluate the potential effectiveness of a psychosocial intervention based on the principles of motivational interviewing. The novel intervention will assist living donor candidates to think through any remaining concerns or questions that they may have about living donation. If the intervention is effective, it may help to prevent post-donation problems related to psychological and health outcomes.

Detailed Description: The protection of living donors' well-being and the prevention of any negative consequences of donation are among the foremost priorities in transplantation. Some donors experience poor psychosocial outcomes after donation, including psychological distress, poor perceived physical well-being, and strained family relationships. No preventive interventions have been mounted or tested for their ability to avert poor psychosocial outcomes in living donors. The present study will provide an initial test of a new intervention for this purpose. The new intervention utilizes motivational interviewing (MI) to address remaining concerns that individuals may have about proceeding with living donation. Study participants will be randomly assigned to either (a) participate in the MI intervention (during which they will be asked to answer a series of questions to help them better delineate their reasons for and against proceeding with living organ donation), (b) participate in a comparison intervention designed to inform them about healthy lifestyle habits, or (c) not receive any intervention. We plan to recruit a maximum of 150 adults who are considering whether to serve as living kidney or liver donors. We hypothesize that participants receiving the MI intervention will have superior outcomes (less psychological distress, fewer physical health complaints, better interpersonal relationships within their family, better overall quality of life)after donation.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Motivational Interviewing	Motivational Interviewing	Subjects will receive two, individual telephone sessions with an interventionist, each lasting approximately 30-45 minutes. The sessions will focus on assisting subjects to delineate their reasons for or against proceeding with living organ donation and assisting subjects to resolve any lingering concerns about their decisions regarding donation.
Enhanced Standard Care	Healthy Lifestyles Education	Subjects will receive two individual telephone sessions with an interventionist, each lasting approximately 30-45 minutes. The sessions will focus on providing educational information to subjects regarding healthy lifestyle issues (healthy eating, diet, exercise, quitting smoking).

Primary Outcome Measures

Name	Time	Method
psychological distress	3 months post-donation	PRIME-MD depression and anxiety modules, BSI anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items
interpersonal relationship quality and distress	3 months post-donation	Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales
somatic/physical health perceptions	3 months post-donation	Concerns About Donation Effects items, Simmons Post-donation Medical Concerns, Brief Pain Inventory short form, FACIT-fatigue scale, Post-surgery Body Image Questionnaire, Post-donation Symptom Checklist, Simmons Concerns About Future Health items, Simmons Perceived Stressfulness of Donation items
quality of life	3 months post-donation	RAND-12

Secondary Outcome Measures

Name	Time	Method
Satisfaction with intervention	pre-donation (on average, 1 week post-intervention but before donation has occurred)	adapted Client Satisfaction Scale
Quality of decision to donate	pre-donation (on average, 1 week post-intervention but before donation has occurred)	Simmons Ambivalence Scale items; Decision Conflict Scale, Decision Satisfaction Scale items

Locations (1): University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States