DepressionACTNCT03438656
Activating and Connecting Teens (ACT) Study
A study testing Behavioral Activation in people with Depression, run by University of Washington at 1 site in United States.
Trial summary
National data indicate over 650,000 children and adolescents are exposed to physical, sexual, or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history of childhood maltreatment (CM) are at least twice as likely to develop depression and are at substantial risk for nonresponse to… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- current diagnosis of clinical depression (minor or major) will be recruited as study participants in the Behavioral Activation (BA) Group
Who cannot join
- IQ < 80;
- non-English speaking youth or parent;
- current PTSD diagnosis;
- lifetime history of a developmental (e.g., autism), neurological (e.g., epilepsy), psychotic, bipolar, or substance disorder;
- current psychiatric (e.g., antidepressants) or other mood altering medication (e.g., steroids) other than AD/HD medication;
- requiring a higher level of care (i.e., inpatient hospitalization) due to suicidality or other mental or physical health related problem.
- Any youths who are currently being maltreated will not be enrolled to ensure that participants do not have active safety concerns.
- Full course of other evidence-based depression intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System
National data indicate over 650,000 children and adolescents are exposed to physical, sexual, or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history of childhood maltreatment (CM) are at least twice as likely to develop depression and are at substantial risk for nonresponse to current best practice depression interventions (i.e., cognitive behavioral therapy and antidepressants) compared to non-maltreated peers. Research suggests that CM increases risk for depression through disruptions in the positive valence system, such as reward processing, and Behavioral Activation (BA) may be an alternative depression intervention that targets these deficits. This proposal will examine whether BA intervention reduces depression and anhedonia in a sample of depressed adolescents, aged 13-18, with variable histories of CM exposure (BA Group). A total of 30 depressed adolescents will be recruited to undergo a 12-week course of BA. All participants will undergo clinical assessment to measure depression symptoms and anhedonia at baseline (Week 0) and post- (Week 12) treatment.
- Conditions
- Depression
- Being tested
- Behavioral Activation
- Keywords
- Depression, Childhood adversity, Behavioral Activation, Reward Processing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation Arm | Experimental | See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation. Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome.
Measured: Week 12 (post-treatment)
Anhedonia/Activation
Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Mar 2018
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jessica Jenness, University of Washington
- Investigators
- Jessica L Jenness, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438656
- Sponsor's protocol ID
- STUDY00002283
- Other IDs
- K23MH112872
- Acronym
- ACT
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2018
- Last updated
- 2 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System
- ClinicalTrials.gov ID
- NCT03438656
- Acronym / sponsor ID
- ACT / STUDY00002283
- Conditions
- Depression
- Keywords
- Depression, Childhood adversity, Behavioral Activation, Reward Processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital, National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
National data indicate over 650,000 children and adolescents are exposed to physical, sexual, or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history of childhood maltreatment (CM) are at least twice as likely to develop depression and are at substantial risk for nonresponse to current best practice depression interventions (i.e., cognitive behavioral therapy and antidepressants) compared to non-maltreated peers. Research suggests that CM increases risk for depression through disruptions in the positive valence system, such as reward processing, and Behavioral Activation (BA) may be an alternative depression intervention that targets these deficits. This proposal will examine whether BA intervention reduces depression and anhedonia in a sample of depressed adolescents, aged 13-18, with variable histories of CM exposure (BA Group). A total of 30 depressed adolescents will be recruited to undergo a 12-week course of BA. All participants will undergo clinical assessment to measure depression symptoms and anhedonia at baseline (Week 0) and post- (Week 12) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation Arm | Experimental | Behavioral: Behavioral ActivationSee treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- current diagnosis of clinical depression (minor or major) will be recruited as study participants in the Behavioral Activation (BA) Group
Key exclusion criteria (8 listed)
- IQ < 80;
- non-English speaking youth or parent;
- current PTSD diagnosis;
- lifetime history of a developmental (e.g., autism), neurological (e.g., epilepsy), psychotic, bipolar, or substance disorder;
- current psychiatric (e.g., antidepressants) or other mood altering medication (e.g., steroids) other than AD/HD medication;
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 |
|---|---|---|
| Behavioral ActivationThe Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance. | Behavioural | Behavioral Activation Arm |
Primary outcome
Depression
Time frame: Week 12 (post-treatment)
Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome.
Anhedonia/Activation
Time frame: Week 12
Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jessica L Jenness, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Depression, run by University of Washington 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 2 May 2024. 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?
Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression (time frame: Week 12 (post-treatment)). 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 2 May 2024.