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Evaluating the Telehealth Single Session Consultation Service

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ClinicalTrials.gov Identifier: NCT04725578
Recruitment Status : Not yet recruiting
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Jessica Schleider, Stony Brook University

Brief Summary:

Stony Brook University is home to several mental health clinics, that all work towards achieving overall wellness of their clients. The goals of Stony Brook University are met with the help of associated clinics that strive to improve wellness of individuals and their communities by helping to treat both mental and physical health impairments. One of these many clinics is the Krasner Psychological Center (KPC).

At present, the KPC faces a challenge common to virtually all mental health clinics across the United States: the demand for psychological services far outpaces the number of available providers. Indeed, in the US, approximately 70% of those in need of mental health services do not receive them. As such, wait-lists at mental health clinics like the KPC are increasingly long, and longer wait-times for psychotherapy have predicted worse clinical outcomes once treatment is accessed (i.e., a 'nocebo' effect). Thus, there is a pressing need for effective, sustainable service delivery models that may facilitate more rapid access to care-for instance, providing a low-intensity service rapidly after an individual decides to seek treatment, capitalizing on client motivation. This sort of rapidly-provided, low-intensity service might have the added benefit of reducing overall waitlist lengths--e.g., if some subset of clients find the low-intensity service to be sufficient, a single session might be sufficient (in some cases) to spur positive behavioral and emotional change.

One solution to this problem is the integration of single-session services into mental health clinics. Extensive research suggests that both youths and adults can benefit from just one session of goal-directed counseling, and these clinical benefits have been observed for a wide array of problems-including anxiety, depression, self-harm, and interpersonal conflicts. This research suggests the possibility that, for some subset of clients, a single session of counseling may be helpful, or even sufficient, in reducing clinical distress. Further, offering such service in a telehealth format will alleviate frequently cited barriers to care like transportation, geographic constraints, and limited time.

Therefore, the objective of this study is to examine the feasibility, acceptability, and short-term effects of the new telehealth-Single-Session Consultation (SSC) service, which is presently being provided to clients on the waiting list for psychotherapeutic services at the Krasner Psychological Center. The telehealth-SSC offers clients the opportunity to participate in a single, goal-directed consultation session based on Solution-Focused Brief Therapy (SFBT) within two weeks of inquiring about services at the KPC (typically, clients wait 2-6 months prior to their initial clinic appointment). SFBT is an evidence-based therapy approach that guides services offered by existing single-session therapy clinics internationally. Clients who participate in the telehealth-SSC at any of these clinics may find the session helpful; two weeks after participating in the session, they receive the option to remain on the waitlist for long-term psychotherapy or remove themselves from the waitlist for psychotherapy, depending on whether they feel their clinical needs have been successfully addressed.


Condition or disease Intervention/treatment Phase
Mental Health Impairment Behavioral: Telehealth Single Session Consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Telehealth Single Session Consultation Service
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telehealth Single Session Consultation Behavioral: Telehealth Single Session Consultation
A remotely delivered, single, goal-directed consultation session based on Solution-Focused Brief Therapy (SFBT). SFBT is an evidence-based therapy approach that is primarily focused on the client's present problems and their immediate future. When using SFBT in a single-session the aim of the intervention becomes empowering the client to take the smallest possible steps towards their desired future.
Other Name: Telehealth-SSC




Primary Outcome Measures :
  1. Change in PHQ-9 [ Time Frame: Baseline & 2-week follow-up ]
    The PHQ-9 asks participants to rate 9 questions assessing dimensions of depression on a scale of 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 27 with higher scores indicating higher levels of depression.

  2. Change in GAD-7 [ Time Frame: Baseline & 2-week follow-up ]
    The GAD-7 asks participants to rate 7 statements based on how generally anxious they have felt over the past 2 weeks on a 4 point scale ranging from 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 21 with higher scores representing higher generalized anxiety.

  3. Change in Beck Hopelessness Scale [ Time Frame: Baseline & 2-week follow-up ]
    Respondents report agreement with 4 items, each rated on a 0 (Very False) to 3 (Very True) scale, indicating levels of hopelessness about the future. Higher summed scores reflect greater levels of hopelessness with total scores ranging from 0-12.

  4. Change in Readiness for Change Ruler [ Time Frame: Baseline & immediately Post-SSC ]
    The readiness for change ruler is a 3 item measure that examines participant's willingness to change to improve their mental health on a 0 (not at all confident/important/ready) to 10 scale (completely confident/ready). The total score ranges from 0 to 30, with higher score indicating higher levels of willingness to change.


Secondary Outcome Measures :
  1. Working Alliance Inventory - Short [ Time Frame: Immediately Post-SSC ]
    The working alliance inventory asks participants to rate 12 statements regarding their personal experiences they had with their therapist on a scale of 1 (Never) to 7 (Always). The overall score will be a single mean score (possible range: 1-7; items 4 and 10 are reversed scored) reflecting patient-rated working alliance with their therapist. Higher scores reflect a stronger perceived therapeutic alliance.

  2. Consultation Feedback Form [ Time Frame: Immediately Post-SSC ]
    The consultation feedback form contains 5 items, rated on a 1 ("Not at all") to 5 ("Very much") Likert scale, indicating endorsement of a series of statements about responses to the Single Session Consultation program (e.g., "Did you find the consultation helpful in addressing your concern(s)?" and "How hopeful are you that the action plan will be useful?"). Higher mean scores across these 5 items indicate greater perceived usefulness of the SSC.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adolescent (ages 13+) and adult clients on the waitlist for clinical psychotherapy services at the KPC will be eligible to take part in this research.

Exclusion Criteria:

  • Child clients at the KPC under the age of 13 will not be eligible to participate in this study, because the teletherapy-Single-Session Consultation service presently being offered at the KPC is designed for use with adolescents and adults (i.e., it would be developmentally inappropriate for younger children.).
  • Non-English speaking individuals will not be eligible to receive any clinical services at the KPC because all therapists at the clinics are English-speaking.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725578


Contacts
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Contact: Jessica Schleider 631-632-4131 jessica.schleider@stonybrook.edu

Locations
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United States, New York
Stony Brook University
Stony Brook, New York, United States, 11790
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Jessica L Schleider, PhD Stony Brook University
  Study Documents (Full-Text)

Documents provided by Jessica Schleider, Stony Brook University:
Statistical Analysis Plan  [PDF] January 18, 2021

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Responsible Party: Jessica Schleider, Assistant Professor of Psychology, Stony Brook University
ClinicalTrials.gov Identifier: NCT04725578    
Other Study ID Numbers: IRB2019-00362-2
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant-level data will be made available on Open Science Framework upon conclusion of the study
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No