AnxietyTeenCBMNCT02156531
Cognitive Bias Modification for Youth Anxiety
A study testing Self-Administered, Active Cognitive Bias Modification (CBM) in people with Anxiety, run by Kaiser Permanente at 1 site in United States.
Trial summary
Research in the last fifteen years suggests that anxious individuals selectively attend towards threatening information. Attention modification interventions for internalizing adults have been developed to target cognition at this basic level; these programs have demonstrated initial efficacy in attention bias and… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Self-Administered, Active Cognitive Bias Modification (CBM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 488 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth age between 12.0 and 17.9 years old
- Youth, parent able to complete assessments in English
- Youth performing at 7th-12th grade achievement level
- Youth vision sufficient to read book of typical size print
- Youth access to home computer, Internet for 3 months
- Assessment of Childhood Disorders (ADIS)-confirmed diagnosis of generalized anxiety disorder (GAD) and/or social phobia (SOP) and/or separation anxiety disorder (SAD)
Who cannot join
- Youth diagnosis of learning or processing problem
- Youth diagnosis of attention deficit hyperactivity disorder (ADHD), except if symptoms are stable and controlled by medication for > 1 mo.
- Youth diagnosis of psychotic disorder
- Youth primary complaint of condition other than anxiety (as determined by the research interviewer during the baseline survey)
- psychotic features or delayed inform/visual processing
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: An Efficacy-Effectiveness Trial of Cognitive Bias Modification for Youth Anxiety
Research in the last fifteen years suggests that anxious individuals selectively attend towards threatening information. Attention modification interventions for internalizing adults have been developed to target cognition at this basic level; these programs have demonstrated initial efficacy in attention bias and anxiety symptom reduction. To date, there have been minimal published studies of attention modification in youths with clinical levels of anxiety.
This study is a large randomized efficacy-effectiveness trial (N = 498) to test the benefit of this low-cost, computerized attention modification intervention (Cognitive Bias Modification (CBM) computer application) for anxiety disorders and symptomatology in youth ages 12 to 17. This trial conducted will compare three intervention arms, all of which include underlying treatment as usual (TAU). The investigators directly test the level of clinical support ("scaffolding") needed to adequately deliver self-administered CBM to anxious youth, a finding that will be key to preparing for future deployment-focused trials. The investigators will compare an attention control version of the CBM program (Arm 1) to two active versions of the CBM intervention that have varying levels of patient clinical support: a self-administered CBM program that participants download and install on their home computers (Self-Administered CBM-only; Arm 2), and the same CBM program paired with an adherence promotion (AP) component delivered via brief telephone calls from study "coaches," including as needed, brief motivational enhancement and/or technical assistance (Self-Administered CBM+AP; Arm 3).
The investigators expect that youth receiving CBM and CBM+AP will have improvement in anxiety symptoms and functioning. The investigators will also complete a cost-effectiveness analysis to examine potential costs offset by this intervention.
- Conditions
- Anxiety
- Being tested
- Self-Administered, Active Cognitive Bias Modification (CBM), Self-Administered, minimally effective attention-control version of the CBM program
- Keywords
- Anxiety, Youth Anxiety, CBM, Cognitive Bias Modification, Adolescents
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Administered, Active Cognitive Bias Modification (CBM)Behavioural
Cognitive Bias Modification (CBM) is a novel treatment delivered via a downloadable computer program. CBM retrains individuals' attention away from negative/threatening stimuli and toward more balanced attention toward neutral stimuli.
Self-Administered, minimally effective attention-control version of the CBM programBehavioural
Identical to the active CBM program except that during the presentation of the trails where a disgusted face is present, the probe will appear with equal frequency (50-50) in the position of disgusted or neutral face. This, the balanced (random) presentation of the probe in this condition is not designed to explicitly train attention away from threat and toward neutral stimuli, in contrast to the active version of CBM.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control Condition | Placebo comparator | 3.c.14.5. Arm 1: Attention Control Condition. The minimally effective attention-control group procedure is identical to the active CBM procedure except that during the presentation of the trials where a disgusted face is present, the probe will appear with equal frequency (50-50) in the position of disgusted or neutral face. Thus, the balanced (random) presentation of the probe in this condition is not designed to explicitly train attention away from threat and toward neutral stimuli, in contrast to the active versions of CBM in Arms 2 and 3. Receives: Behavioral: Self-Administered, minimally effective attention-control version of the CBM program |
| Arm 2: Self-administered CBM only | Experimental | 3.c.14.6. Arm 2: Self-Administered CBM Only. Youth assigned to this arm will receive the self-administered active CBM intervention. As described above in detail, in the 80% of CBM trials where a neutral and disgust face are both presented, the probe always replaces the neutral face. Thus, participants are trained to disengage their attention from threat. These youth do not receive Adherence Promotion telephone calls. Receives: Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM) |
| Arm 3: Self-administered CBM + Adherence Promotion | Experimental | 3.c.14.7. Arm 3: Self-Administered CBM + Adherence Promotion. Youth assigned to this arm will receive both the self-administered active CBM intervention and the telephone coach calls to deliver the Adherence Promotion (AP) procedures. AP procedures are intended to compensate for the important nonspecific 'scaffolding' provided by research staff when CBM has been traditionally delivered in laboratories. This includes technical assistance with use of the program, support/encouragement, motivational enhancement, and brainstorming solutions to barriers to regular sessions. The addition of AP to the 3rd arm of this trial attempts to recreate much of this nonspecific, yet likely important, support of in-person interventions, which we hypothesize will lead to greater participant adherence to the program and therefore better clinical outcomes. Receives: Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effectiveness
We hypothesize that CBM can be successfully delivered in this health-care setting, and that active CBM will demonstrate clinical effectiveness.
Hypothesis 1a: The combined active CBM conditions will lead to greater rates of remission for anxiety diagnoses and to greater improvement on secondary indices of symptoms, diagnoses, and functioning, compared to the control condition (Arms 2 + 3 vs. Arm 1). Hypothesis 1b: CBM+AP will result in greater rates of remission for anxiety diagnoses (primary outcome) and greater improvement in secondary clinical indices, compared to CBM-only (Arm 3 vs. Arm 2).
Measured: 6 month follow up (post intervention)
Secondary outcomes (1)
Cost Effectiveness
Overall, we expect that active CBM will be cost-effective from the healthcare organization perspective, including patient direct and indirect costs.
Hypothesis 2a: Incremental cost-per-unit of anxiety-free-days (AFDs) and health-related quality of life (QALYS) will be lower for active CBM (Arm 2 + Arm 3), relative to the control condition (Arm 1) due to improvements in anxiety symptomology.
Hypothesis 2b: Cost-per-unit of improved AFDs and QALYS will be lower in CBM-only (Arms 2) relative to CBM+AP (Arm 3). Although we expect both active CBM arms to improve anxiety, we expect that CBM+AP (Arm 3) will be considerably more costly due to increased labor costs of AP phone coaching, while producing only a moderate incremental clinical benefit beyond the effects of CBM only (Arm 2)
Measured: 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2019
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Greg Clarke, PhD, Principal investigator, Kaiser PermanenteRobin Weersing, PhD, Principal investigator, San Diego State UniversityNader Amir, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156531
- Sponsor's protocol ID
- 1R01MH101118-01A1
- Other IDs
- 1R01MH101118-01A1
- Acronym
- TeenCBM
- Status last verified
- Aug 2019
- First submitted
- 3 Jun 2014
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reetz S, Clarke G, Weersing R, Amir N, Dickerson J, Lynch FL, Leo MC, Rawlings AM, Lee MH, Gille S. The ReThink study: a 3-arm parallel randomized trial of cognitive bias modification, with and without adherence promotion, for adolescent anxiety disorder: trial design and protocol. BMC Psychiatry. 2019 Oct 22;19(1):306. doi: 10.1186/s12888-019-2296-z.
PubMed 31640613
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy-Effectiveness Trial of Cognitive Bias Modification for Youth Anxiety
- ClinicalTrials.gov ID
- NCT02156531
- Acronym / sponsor ID
- TeenCBM / 1R01MH101118-01A1
- Conditions
- Anxiety
- Keywords
- Anxiety, Youth Anxiety, CBM, Cognitive Bias Modification, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2014
- Primary completion
- Jun 2019 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research in the last fifteen years suggests that anxious individuals selectively attend towards threatening information. Attention modification interventions for internalizing adults have been developed to target cognition at this basic level; these programs have demonstrated initial efficacy in attention bias and anxiety symptom reduction. To date, there have been minimal published studies of attention modification in youths with clinical levels of anxiety.
This study is a large randomized efficacy-effectiveness trial (N = 498) to test the benefit of this low-cost, computerized attention modification intervention (Cognitive Bias Modification (CBM) computer application) for anxiety disorders and symptomatology in youth ages 12 to 17. This trial conducted will compare three intervention arms, all of which include underlying treatment as usual (TAU). The investigators directly test the level of clinical support ("scaffolding") needed to adequately deliver self-administered CBM to anxious youth, a finding that will be key to preparing for future deployment-focused trials. The investigators will compare an attention control version of the CBM program (Arm 1) to two active versions of the CBM intervention that have varying levels of patient clinical support: a self-administered CBM program that participants download and install on their home computers (Self-Administered CBM-only; Arm 2), and the same CBM program paired with an adherence promotion (AP) component delivered via brief telephone calls from study "coaches," including as needed, brief motivational enhancement and/or technical assistance (Self-Administered CBM+AP; Arm 3).
The investigators expect that youth receiving CBM and CBM+AP will have improvement in anxiety symptoms and functioning. The investigators will also complete a cost-effectiveness analysis to examine potential costs offset by this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Attention Control Condition | Placebo comparator | Behavioral: Self-Administered, minimally effective attention-control version of the CBM program3.c.14.5. Arm 1: Attention Control Condition. The minimally effective attention-control group procedure is identical to the active CBM procedure except that during the presentation of the trials where a disgusted face is present, the probe will appear with equal frequency (50-50) in the position of disgusted or neutral face. Thus, the balanced (random) presentation of the probe in this condition is not designed to explicitly train attention away from threat and toward neutral stimuli, in contrast to the active versions of CBM in Arms 2 and 3. |
| Arm 2: Self-administered CBM only | Experimental | Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM)3.c.14.6. Arm 2: Self-Administered CBM Only. Youth assigned to this arm will receive the self-administered active CBM intervention. As described above in detail, in the 80% of CBM trials where a neutral and disgust face are both presented, the probe always replaces the neutral face. Thus, participants are trained to disengage their attention from threat. These youth do not receive Adherence Promotion telephone calls. |
| Arm 3: Self-administered CBM + Adherence Promotion | Experimental | Behavioral: Self-Administered, Active Cognitive Bias Modification (CBM)3.c.14.7. Arm 3: Self-Administered CBM + Adherence Promotion. Youth assigned to this arm will receive both the self-administered active CBM intervention and the telephone coach calls to deliver the Adherence Promotion (AP) procedures. AP procedures are intended to compensate for the important nonspecific 'scaffolding' provided by research staff when CBM has been traditionally delivered in laboratories. This includes technical assistance with use of the program, support/encouragement, motivational enhancement, and brainstorming solutions to barriers to regular sessions. The addition of AP to the 3rd arm of this trial attempts to recreate much of this nonspecific, yet likely important, support of in-person interventions, which we hypothesize will lead to greater participant adherence to the program and therefore better clinical outcomes. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Youth age between 12.0 and 17.9 years old
- Youth, parent able to complete assessments in English
- Youth performing at 7th-12th grade achievement level
- Youth vision sufficient to read book of typical size print
- Youth access to home computer, Internet for 3 months
Key exclusion criteria (5 listed)
- Youth diagnosis of learning or processing problem
- Youth diagnosis of attention deficit hyperactivity disorder (ADHD), except if symptoms are stable and controlled by medication for > 1 mo.
- Youth diagnosis of psychotic disorder
- Youth primary complaint of condition other than anxiety (as determined by the research interviewer during the baseline survey)
- psychotic features or delayed inform/visual processing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Administered, Active Cognitive Bias Modification (CBM)Cognitive Bias Modification (CBM) is a novel treatment delivered via a downloadable computer program. CBM retrains individuals' attention away from negative/threatening stimuli and toward more balanced attention toward neutral stimuli. | Behavioural | Arm 2: Self-administered CBM only, Arm 3: Self-administered CBM + Adherence Promotion |
| Self-Administered, minimally effective attention-control version of the CBM programIdentical to the active CBM program except that during the presentation of the trails where a disgusted face is present, the probe will appear with equal frequency (50-50) in the position of disgusted or neutral face. This, the balanced (random) presentation of the probe in this condition is not designed to explicitly train attention away from threat and toward neutral stimuli, in contrast to the active version of CBM. | Behavioural | Attention Control Condition |
Primary outcome
Clinical effectiveness
Time frame: 6 month follow up (post intervention)
We hypothesize that CBM can be successfully delivered in this health-care setting, and that active CBM will demonstrate clinical effectiveness. Hypothesis 1a: The combined active CBM conditions will lead to greater rates of remission for anxiety diagnoses and to greater improvement on secondary indices of symptoms, diagnoses, and functioning, compared to the control condition (Arms 2 + 3 vs. Arm 1). Hypothesis 1b: CBM+AP will result in greater rates of remission for anxiety diagnoses (primary outcome) and greater improvement in secondary clinical indices, compared to CBM-only (Arm 3 vs. Arm 2).
1 secondary outcome
Cost Effectiveness
Time frame: 12 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Derived from this study: PubMed 31640613Reetz S, Clarke G, Weersing R, Amir N, Dickerson J, Lynch FL, Leo MC, Rawlings AM, Lee MH, Gille S. The ReThink study: a 3-arm parallel randomized trial of cognitive bias modification, with and without adherence promotion, for adolescent anxiety disorder: trial design and protocol. BMC Psychiatry. 2019 Oct 22;19(1):306. doi: 10.1186/s12888-019-2296-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Clarke, PhD principal investigator
Kaiser Permanente
Robin Weersing, PhD principal investigator
San Diego State University
Nader Amir, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Administered, Active Cognitive Bias Modification (CBM) in people with Anxiety, run by Kaiser Permanente 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Clinical effectiveness (time frame: 6 month follow up (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156531, which also lists 1 linked publication.
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 19 Aug 2019.