Suicide, AttemptedPhase 1CBT-RPNCT00589641
Relapse Prevention for Suicidal Dually Diagnosed Youths
A Phase 1 study testing CBT-RP (relapse prevention) + Enhanced TAU and Enhanced TAU Alone in people with Suicide, Attempted and Suicide, Ideation, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to develop, refine, and pilot test an augmenting cognitive behavior relapse prevention intervention (CBT-RP) for suicidal, depressed, and alcohol/substance abusing adolescents. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Suicide, Attempted, Suicide, Ideation, Depression
- What is being tested?
- CBT-RP (relapse prevention) + Enhanced TAU and Enhanced TAU Alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Oct 2010
- Phase
- Phase 1
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
- Teenagers 13-19 living with parents, or foster parents, at least one of whom is English speaking and willing to participate
- Participation in ongoing treatment in the community (or willing to accept a referral for treatment as usually delivered in the community)
- Marijuana or alcohol use or dependence disorder
- Depressive disorder (major depression, dysthymia, depressive disorder NOS)
- High suicide risk as reflected in: (a) recent suicidal behaviors (suicide attempts, aborted attempts, interrupted attempts, or suicide plans) in last 4 weeks OR (b)lifetime history of suicidal behaviors together with current clinically significant suicidal ideation (measured on a self-report questionnaire)
Who cannot join
- Substance Dependence Disorder other than alcohol or cannabis or nicotine
- SUD severity such that higher (more intensive) level of treatment (e.g., residential, hospitalization) is needed
- Psychiatric difficulty other than substance abuse, suicidality, or depression that needs to be the primary focus of treatment (e.g., severe eating disorder or psychosis)
- Evidence of mental retardation or poor receptive vocabulary as assessed with Peabody Picture Vocabulary Test
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
The purpose of this study is to develop, refine, and pilot test an augmenting cognitive behavior relapse prevention intervention (CBT-RP) for suicidal, depressed, and alcohol/substance abusing adolescents. No hypotheses are being tested, but it is expected that CBT-RP in addition to treatment as usual will result in improved outcomes relative to treatment as usual alone.
Read the detailed description
Suicide attempts are not only associated with increased likelihood of eventual death by suicide (Lonnqvist \& Ostano, 1991), increased risk of repeat suicidal behavior (Goldston et al., 1999; Leon et al., 1989), and risk of physical injury, but suicidality is also one of the primary reasons for psychiatric emergencies and psychiatric hospitalizations (Peterson et al., 1996). Suicide attempters, particularly repeat attempters, often have histories of both depression and substance abuse problems. Cognitive behavioral interventions have been shown to have promise in the treatment of depression (Brent et al., 1997), suicidality (Henriques, Beck, \& Brown, 2002), and substance use disorders in youths (Dennis et al., in press; Kaminer et al., 2002). Relapse prevention approaches have been shown to have utility with substance abusing adults (Witkiewitz \& Marlatt, 2004), and conceptually are well suited for the prevention of both suicidal behavior and substance use among young people. The purpose of the research outlined in this application is therefore to develop, refine, and test a cognitive behavioral relapse prevention intervention (CBT-RP) for dually diagnosed suicidal adolescents and young adults.
The specific aims of this research are as follows:
- To develop and refine a cognitive behavioral relapse prevention treatment manual for suicidal adolescents and young adults with comorbid depressive and substance use disorders.
- To develop and pilot test procedures for training therapists to conduct CBT-RP. Methods for assessing therapist competence and adherence to the protocols, and certification standards will be developed and refined.
- To assess the feasibility of CBT-RP via monitoring of rates of recruitment and retention of subjects, monitoring of therapist adherence and deviation from the protocols, and monitoring of adverse events.
- To assess the feasibility of the assessment methods and outcome measures to be used in this study as reflected in burden in completing assessments over the course of treatment.
- To estimate the degree of change and variability of response to CBT-RP relative to no CBT-RP as an add-on treatment to Treatment as Usual (TAU) in the community on the primary outcomes of suicidal ideation, depressive symptoms, and substance use problem severity.
- To assess the acceptability of CBT-RP relative to no CBT-RP as an add-on treatment to TAU in the community as assessed qualitatively via exit interviews and quantitatively via ratings of patient satisfaction
There are four phases to this treatment development study: (1) initial manual and protocol development (not requiring human subject involvement); (2) piloting (and revision) of the manual by the investigators; (3) training and supervision of new therapists using the new intervention; and, (4) the pilot randomized controlled trial. We have completed the first phase of this study. Currently, we are involved in completing pilot testing and initiating training of new therapists with the protocol (n=12). A subsequent pilot randomized controlled trial will be used to examine feasibility and preliminary evidence of effects (and variability of effects) of CBT-RP as an augmenting intervention (n=36).
- Conditions
- Suicide, Attempted, Suicide, Ideation, Depression, Substance Abuse
- Being tested
- CBT-RP (relapse prevention) + Enhanced TAU, Enhanced TAU Alone
- Keywords
- adolescents, suicidal ideation and behavior, depression, substance abuse
- Medical subject headings
- Suicide, Attempted, Suicide, Depression, Substance-Related Disorders, Suicidal Ideation, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-RP (relapse prevention) + Enhanced TAUBehavioural
CBT-RP is an 20-week augmenting intervention. CBT-RP is based primarily on Alan Marlatt's cognitive behavioral relapse prevention model for substance abuse, but also includes motivational interviewing and mindfulness meditation approaches. Sessions are twice a week in first week, then weekly thereafter, with tapering to biweekly in the last 8 weeks depending on improvement. Participants also receive treatment as usual, and monthly check-ins regarding treatment use.
Enhanced TAU AloneBehavioural
Treatment as usual in the community, monthly check-ins regarding treatment use or needs, and monitoring
| Study group | Role | What they receive |
|---|---|---|
| CBT-RP + Enhanced TAU | Experimental | CBT-RP augmenting relapse prevention intervention, in addition to enhanced treatment as usual, monthly check-ins, and monitoring Receives: Behavioral: CBT-RP (relapse prevention) + Enhanced TAU |
| Enhanced TAU (Treatment as Usual) | Active comparator | Treatment as usual in the community, monthly monitoring regarding service use and needs, monitoring Receives: Behavioral: Enhanced TAU Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
suicide ideation and behavior
Measured: pre-treatment, 10 weeks, end of treatment, 3-month follow-up
Secondary outcomes (1)
depression severity, alcohol/cannabis abuse impairment
Measured: pre-treatment, 10 weeks, end of treatment, 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJul 2005
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- UConn Health, University of North Carolina, Chapel Hill, University of North Carolina, Greensboro
- Responsible party
- Sponsor
- Investigators
- David B Goldston, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589641
- Sponsor's protocol ID
- Pro00006806
- Other IDs
- R34MH067904, 303-7105
- Acronym
- CBT-RP
- Status last verified
- Jun 2010
- First submitted
- 31 Dec 2007
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes