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Completed

NCT Number: NCT01233700

Brief Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Score of 1 or greater on the Simmons Ambivalence Scale;
  • Must be able to speak English;
  • Have been evaluated as a potential living kidney or liver donor candidate;
  • Aged 18 or older

Treatment and study plan

Motivational Interviewing

Behavioral

Standard motivational interviewing techniques will be applied to assist subjects to consider and work to resolve any remaining concerns, doubts, or ambivalence about their decision about donating an organ to someone else.

Healthy Lifestyles Education

Behavioral

Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.

Primary outcomes

  1. psychological distress

    Time frame: 6 weeks post-donation

    PRIME-MD depression and anxiety modules, Brief Symptom Inventory (BSI) anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items

  2. somatic/physical health perceptions

    Time frame: 6 weeks 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

  3. interpersonal relationship quality and distress

    Time frame: 6 weeks post-donation

    Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales

  4. quality of life

    Time frame: 6 weeks post-donation

    RAND-12

  5. psychological distress

    Time frame: 3 months post-donation

    PRIME-MD depression and anxiety modules, BSI anxiety items, Simmons Feelings About Donation items; Simmons Psychosocial Concerns About Donation items

  6. somatic/physical health perceptions

    Time frame: 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

  7. interpersonal relationship quality and distress

    Time frame: 3 months post-donation

    Simmons Family Relationship items, Short Dyadic Adjustment Scale, Family ICPS conflict and intimacy subscales

  8. quality of life

    Time frame: 3 months post-donation

    RAND-12

Secondary outcomes

  1. Satisfaction with intervention

    Time frame: pre-donation (on average, 1 week post-intervention but before donation has occurred)

    adapted Client Satisfaction Scale

  2. Quality of decision to donate

    Time frame: pre-donation (on average, 1 week post-intervention but before donation has occurred)

    Simmons Ambivalence Scale items; Decision Conflict Scale, Decision Satisfaction Scale items

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 3, 2010
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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