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Prodromal SymptomsNCT03738046

HOPE TEAM - Clinical High Risk Group CBSST

A study testing Cognitive Behavioral Therapy in people with Prodromal Symptoms and Prodromal Stage, run by University of Pittsburgh at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Community-based treatments for adolescents at risk for psychosis are not widely available, nor are there established, gold-standard psychosocial group interventions for this population. Read more about this study

Who is it for?
Ages 13 to 19 years
What is being tested?
Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Sep 2019to 1 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients may be included if they are 13-19 years old and receiving individual therapy or professional assessment/clinical evaluation as part of the HOPE TEAM.
  • Due to the nature of the definition of "clinical high risk status," these patients may have a variety of clinical diagnoses, but all will be receiving individual therapy or clinical evaluation through the HOPE TEAM due to their elevated risk for developing a psychotic disorder.
  • The individual therapy being provided to patients who are also eligible for HOPE TEAM Group may also vary based on their individual needs and therapy goals.

Who cannot join

  • HOPE TEAM adolescents may be excluded if they express an unwillingness to participate in weekly group therapy and abide by group rules.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Help Overcoming Prodromal Experiences Through Early Assessment & Management - Clinical High Risk Group CBSST

Community-based treatments for adolescents at risk for psychosis are not widely available, nor are there established, gold-standard psychosocial group interventions for this population. The HOPE TEAM, Helping Overcome Prodromal Experiences through Treatment and Evaluation of Adolescent Minds (PI: Bachman; funded by The Pittsburgh Foundation) is an early detection and intervention program for youth at clinical high risk for psychosis which aims to help them by engaging existing community resources, providing assessment, and offering trauma-informed psychotherapy. Embedded within the Family Care Connection Center at Turtle Creek, the HOPE TEAM offers individual psychotherapy as part of its clinical service model. The present study seeks to evaluate, in a small and preliminary sample (n = 20), the feasibility and effectiveness of a 24-week Cognitive-Behavioral Social Skills Therapy (CBSST) group intervention for CHR adolescents who are part of the HOPE TEAM. To that end, the current proposal will seek to conduct brief research assessments to assess the group members' perceptions of the group's utility, as well as their current clinical symptoms and functioning prior to, during, and after participating in this group. The goals of this pilot project are to 1) identify which aspects of the group perceived to be most and least helpful by participating adolescents, and 2) evaluate whether participation in the group meaningfully improves participants' clinical symptoms and functioning. The investigators aim to use these pilot data to guide future selection of treatment targets in this clinical practice, and to identify future strategies for increasing satisfaction and retention in community-based group interventions for CHR adolescents.

Read the detailed description

Accumulating evidence suggests that psychotherapy, particularly CBT (Cognitive-Behavior Therapy) may effectively lower clinical high risk (CHR) youths' risk of developing psychosis. This is consistent with converging evidence that CBT, in both individual and group delivery formats, is effective for reducing positive symptoms of psychosis in those with a diagnosis of schizophrenia. Social Skills Training (SST) for psychosis may be more beneficial for treating negative symptoms and social impairment that accompany schizophrenia.

Given these findings, a group therapy modality combining CBT and SST (CBSST) has been developed with the goal of addressing multiple domains of symptoms and impairments; outcomes of randomized clinical trials have shown that individuals with schizophrenia who received CBSST had improved functioning and less severe psychotic symptoms.4 Furthermore, CBSST is also feasible and well accepted for adolescents and young adults with a first episode of psychosis. However, there are no established, gold-standard psychosocial group interventions for CHR youth, nor have studies specifically investigated the efficacy of CBSST for this population. Since CBSST is effective in adult psychosis, a modified version of this group treatment modality may be useful for CHR adolescents. Given the high levels of victimization, adversity, and stress in community CHR samples, modifications to CBSST for CHR youth should explicitly include a focus on stress coping.

Any clients ages 13-19 already enrolled in HOPE TEAM assessment will be informed about the availability of the HOPE Group by their individual clinician. If interested, potential participants (and their parents, if under age 18) will meet with study PI and Group Leader, to discuss the study and complete the informed consent process. As part of this process, adolescents (and their parents if under 18) will be made aware that their choice to participate or not in the HOPE Group will not affect any other services proved through the HOPE TEAM. Once a minimum of 4 participants are recruited for the HOPE group, the first session will be scheduled.

Group therapy will occur once weekly (60-90-minute sessions) at the HOPE TEAM offices for 24 weeks. The group sessions with consist of 4 skill modules, each of which last 6 sessions. Three of these--the Cognitive, Social Skills, and Problem-Solving Modules-will be modules taken from Cognitive and Behavioral Social Skills Training (CBSST) and modified for use with CHR adolescents. The fourth module-Stress Coping-will be adapted for this sample from an established group CBT treatment for psychosis.

Within 2 weeks of the first group session, participants will complete a very brief (25-40 minute) pre-group assessment battery in the HOPE Team offices with the PI, consisting of the:

  • Youth Inventory 4-Self-Report (YSI-4; ages 14-17) or Adult Self-Report Inventory-4 (ASI-4; ages 18) are 128-item measures that takes approximately 10-15 minutes to complete. Assesses clinical symptoms, compared to a normed sample, across disruptive, mood, anxiety, and other clinical disorders.
  • Prodromal Questionnaire, Brief Version (PQ-B); a 21- item dimensional self-report measure of psychotic symptoms, which takes approximately 5-10 minutes to complete.
  • Defeatist Performance Attitudes Test, a 15-item questionnaire assessing dysfunctional attitudes commonly targeted by CBT therapy. This measure takes approximately 5 minutes to complete.
  • HOPE Group Pre-Survey: A 5-item survey assessing open-ended thoughts about joining a group; takes approximately 5-10 minutes.

To allow for flexibility in the community treatment setting, the HOPE Group will adopt a modular rolling admissions approach to enrollment, in which new group members (up to a maximum group membership of 10) can be enrolled at the start of each module (every 6 sessions). In this case, the pre-group assessment battery will be completed with the participant within 2 weeks of their first group.

Each session will consist of collaborative agenda-setting, review of at-home practice, introduction of a new skill, skill practice, and assigning in-home practice/ summarizing the session. The end of each 60-90-minute group session will consist of 5 minutes of assessment. Group members will complete the:

  • Modified QuickLL, a 14-item measure assessing how participants currently view themselves and their engagement in that day's group session. Each item is rated on a 3-point scale and the measure is totaled, with higher totals indicating better self-perception and greater engagement in the group. This measure takes approximately 2 minutes to complete.
  • Simultaneously, both group leaders will complete the Participation Scale, a 9-item checklist assessing the participation and behavior of each group member, with each item rated from 0 (absence of behavior) to 4 (strong presence of behavior). A total score is computed for each participant, as well as an average for all group members, with higher scores indicated more group engagement and prosocial behaviors.

Within two weeks after completion of the 24-week Group, participants will complete a very brief (25-40 minute) post-group assessment battery in the HOPE Team offices with the PI, consisting of the:

  • Youth Inventory 4-Self-Report, or Adult Self-Report Inventory-4
  • Prodromal Questionnaire, Brief Version
  • Defeatist Performance Attitudes test
  • HOPE Group Post-Survey: A 5-item survey assessing open-ended thoughts about experiences in a group; takes approximately 5-10 minutes.
Medical subject headings
Prodromal Symptoms, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral TherapyBehavioural

    Also called Cognitive Behavioral Social Skills Therapy

    Group therapy will occur once weekly (60-90-minute sessions) at the HOPE TEAM offices for 24 weeks. The group sessions with consist of 4 skill modules, each of which last 6 sessions. Three of these--the Cognitive, Social Skills, and Problem-Solving Modules-will be modules taken from Cognitive and Behavioral Social Skills Training (CBSST; Granholm McQuaid, \& Holden, 2016) and modified for use with CHR adolescents. The fourth module-Stress Coping-will be adapted for this sample from an established group CBT treatment for psychosis (Lecomte, Leclerc, \& Wykes, 2016).

Study groups in NCT03738046
Study groupRoleWhat they receive
Pilot Treatment ArmExperimentalGroup therapy will occur once weekly (60-90-minute sessions) at the HOPE TEAM offices for 24 weeks. The group sessions with consist of 4 skill modules, each of which last 6 sessions. Three of these--the Cognitive, Social Skills, and Problem-Solving Modules-will be modules taken from Cognitive and Behavioral Social Skills Training (CBSST; Granholm McQuaid, \& Holden, 2016) and modified for use with CHR adolescents. The fourth module-Stress Coping-will be adapted for this sample from an established group CBT treatment for psychosis (Lecomte, Leclerc, \& Wykes, 2016).
Receives: Behavioral: Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Utility of CBSST in a CHR group therapy setting

    The goals of this pilot project are to: 1) identify which aspects of the group perceived to be most and least helpful and relevant by participating adolescents, and 2) evaluate whether participants perceive that the group has impacted their clinical symptoms and functioning.

    To measure the perceived utility of CBSST in a CHR group therapy setting, a qualitative analysis of the open-ended HOPE Group Pre- and Post-Surveys will be conducted. In addition, the results of a Likert scale on the pre- and post- surveys will be analyzed. This scale presents examples of 7 domains of skills (e.g. "Thinking clearly") and participants are asked how much they feel the group has assisted them in improving this skill on a five-point Likert scale ("much worse" to "greatly improved").

    Measured: 6 months (end of group)

  2. Non-specific, CHR symptom reduction

    An additional goal of this pilot project is to address and reduce the number or severity of non-specific, sub-threshold symptoms of the clinical high-risk phase of psychotic disorders experienced by the group members.

    To measure symptom reduction, pre-group and post-group scores on the Youth Inventory Self-Report, or Adult-Self Report Inventory (depending on participant age) will be compared for each individual who completed group therapy. Symptom reduction is defined as a decrease in the overall total scores on the Youth Inventory Self-Report or Adult-Self Report Inventory (i.e. the number of symptoms reported by participants).

    Measured: 6 months (end of group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2018
  2. Study start1 Sep 2019 (estimated)
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Dec 2019 (estimated)

Why it stopped: We had a change in staffing that precluded pursing this project

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03738046
Sponsor's protocol ID
PRO18010551
Status last verified
Feb 2020
First submitted
16 Oct 2018
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy in people with Prodromal Symptoms and Prodromal Stage, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Utility of CBSST in a CHR group therapy setting (time frame: 6 months (end of group)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.

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