An interventional study of Problem-Solving Therapy and Attention-matched Control in Depression, Anxiety, Palliative Care and Caregivers, sponsored by Washington University School of Medicine. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.
This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care. Study participants will be randomized to receive either a three-session problem-solving therapy intervention in addition to usual care or three sessions of attention-matched control in addition to usual care.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 532 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Non-Family Caregiver Stakeholders
Exclusion Criteria for Family Caregivers (FCGs)
Exclusion Criteria for Non-Family Caregiver Stakeholders
Family caregivers in the attention control study arm will receive three sessions of attention-matched control in addition to the services and support provided as part of usual outpatient palliative care. Attention-matched control will consist of three "friendly visits" with a trained research staff person.
Other: Attention-matched Control
Family caregivers in the intervention study arm will participate in three problem-solving therapy sessions with a trained interventionist in addition to receiving the services and support provided as part of usual outpatient palliative care.
Behavioral: Problem-Solving Therapy
Each year of the project, the investigators will recruit 6 key stakeholders to participate in individual interviews focused on potential barriers and facilitators to adoption of the PST intervention into clinical practice for a total of 30 unique stakeholders who will be interviewed over the duration of this 5-year study.
Other: In-depth interviews
Over an approximately 3-week period, family caregivers randomized to the intervention study arm will learn and apply a problem-solving approach based on the ADAPT model, which encourages participants to follow five steps when solving caregiving problems: 1) focus on adopting a positive attitude to problem solving, 2) define the problem and set goals, 3) generate a list of alternative solutions to the problem, 4) predict consequences of the alternative solutions, and 5) try implementing the most promising solution from among the list of alternatives. The intervention will be delivered by a trained interventionist over the course of three structured sessions via telephone or videoconferencing technology, depending on the FCG's preference. Session content will be summarized in an intervention manual, which we will provide to all intervention participants. Sessions will last approximately 45-60 minutes.
Over an approximately 3-week period, family caregivers randomized to the attention control study arm will participate in informal conversations ("friendly visits") with a trained member of the research team.
The 30 key stakeholders interviews will discuss how the PST intervention fits into existing clinical practice and institutional values, what might incentivize adoption of the PST intervention, and how the intervention compares to alternative existing or proposed programs.
Change in anxiety as measured by the PROMIS Short Form v1.0 - Anxiety 8a
Family caregivers indicate the frequency with which they experience eight different symptoms of anxiety (8 items); higher scores reflect higher anxiety severity.
Time frame: At the time of enrollment, Week 4, and 30-day follow-up
Change in symptoms of depression as measured by the PROMIS Short Form v1.0 - Depression 8a
Family caregivers indicate the frequency with which they experience eight different symptoms of depression (8 items); higher scores reflect higher depression severity
Time frame: At the time of enrollment, Week 4, and 30-day follow-up
Change in positive aspects of caregiving as measured by Positive Aspects of Caregiving Scale - Short Form (S-PAC; 7 items)
* Family caregivers indicate good things that they experience as a caregiver with seven different statements. The caregivers answer with 1=I disagree with this statement a lot; 2=I disagree with this statement a little; 3=I neither agree nor disagree with this statement; 4=I agree with this statement a little; or 5=I agree with this statement a lot. * Higher scores indicate a more positive caregiving experience
Time frame: At the time of enrollment, Week 4, and 30-day follow-up
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Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine