Major Depressive DisorderNCT02992158
Feasibility of a Behavioral Activation Trial
A study testing behavioral activation and treatment-as-usual in people with Major Depressive Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this project is to train community mental health therapists in behavioral activation (BA) treatment for major depressive disorder and then to conduct a study examining the feasibility of evaluating the effectiveness of BA in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- behavioral activation and treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of MDD based on the SCID for DSM-IV (or DSM-V, if available),
- ability to read at least at the 4th grade level,
- willingness to participate in research,
- willingness to be audio recorded (for both therapists and patient- participants)
Who cannot join
- current or past psychotic disorder, seizure disorder, or clinically significant organic pathology
- acute medical problem requiring immediate inpatient treatment,
- current substance abuse or dependence requiring primary referral to substance abuse program,
- significant suicidal risk/ideation requiring immediate referral or suicidal gesture within the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Feasibility of a Behavioral Activation Trial in Community Mental Health
The goal of this project is to train community mental health therapists in behavioral activation (BA) treatment for major depressive disorder and then to conduct a study examining the feasibility of evaluating the effectiveness of BA in this setting.
Read the detailed description
After finalizing a 9-session BA treatment model for major depressive disorder in the Community Mental Health Center (CMHC) setting, the final treatment manual will be used to train clinicians in BA at the CMHC through workshops and training cases.
Upon completion of training and certification of adequate implementation of BA, a total of 80 patients with MDD will be randomly assigned in a 3:1 ratio to 9 sessions of BA or treatment-as-usual (TAU) at the CMHC. Feasibility will be assessed in terms of (1) percent of eligible patients who refuse randomization, (2) percent of patients who complete 9 sessions of BA treatment, (3) percent of BA homework assignments that are completed, (4) percent of monthly assessments obtained, and (5) patient ratings of credibility and alliance in BA treatment. The ability of CMHC therapists to adequately implement BA will be assessed by rating taped sessions on BA adherence and competence scales. In addition to feasibility/acceptability of BA and TAU, this study is designed to test whether theoretically important targets of BA change over the course of BA treatment, and whether such changes are associated with changes in depressive symptoms. The target measures will be assessed at baseline, month 1, month 2, and month 3. To support the potential role of these targets as the mechanisms of change in BA, change in the target variables will be examined in relation to change in depression symptoms. The investigators will also pilot a potential moderator of treatment effects (trait reward processing, as measured at baseline using the Effort-Expenditure for Rewards Task) to include this potential moderator in a subsequent fully-powered study with the long-term goal of identifying the types of patients most responsive to BA.
- Conditions
- Major Depressive Disorder
- Being tested
- behavioral activation, treatment-as-usual
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral activationBehavioural
treatment-as-usualBehavioural
psychotherapy (and potentially medication) as part of treatment-as-usual provided in a community mental health center
| Study group | Role | What they receive |
|---|---|---|
| behavioral activation | Experimental | The core principles of the BA model are: (1) the key to changing how people feel is helping them change what they do, (2) changes in life can lead to depression, and short-term coping strategies may keep people stuck over time, (3) the clues to figuring out what will be antidepressant for a particular client lie in what precedes and follows the client's important behaviors, (4) structure and scheduling of activities should follow a plan, not a mood, (5) change will be easier when starting small, (6) activities that are naturally reinforcing should be emphasized, (7) the therapist should act as a coach, (8) a problem-solving empirical approach should be emphasized with recognition that all results are useful, (9) patients should be encourages to not just talk, do! (10) possible and actual barriers to activation should be examined. Patients can also receive medications in this arm. Receives: Behavioral: behavioral activation |
| treatment-as-usual | Other | Patients will receive psychotherapy (and potentially medications) as part of treatment-as-usual provided in the CMHC setting. Receives: Behavioral: treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of eligible patients who refuse randomization
We will calculate this value based on our records of patient participation in baseline assessments.
Measured: assessed at baseline
percent of patients who complete 9 sessions of BA treatment
We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).
Measured: 12 weeks
percent of BA homework assignments that are completed
We will calculate this value based on our records of homework assignment completion (tracked weekly by therapist participants and reported to the research staff).
Measured: 12 weeks
percent of monthly assessments obtained
We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).
Measured: 12 weeks
Opinions About Treatment questionnaire
This questionnaire measures patient ratings of the credibility of BA treatment.
Measured: collected at week 2
Brief Alliance Inventory
This questionnaire measures patient ratings of the therapeutic alliance.
Measured: collected at weeks 2, 4, 6, and 8
Secondary outcomes (10)
Behavioral Activation for Depression Scale
Measured: monthly for 3 months
Reward Probability Index
Measured: monthly for 3 months
Hamilton Rating Scale for Depression
Measured: monthly for 3 months
Short Form Health Survey (SF-36)
Measured: monthly for 3 months
Inventory of Depressive Symptomatology
Measured: monthly for 3 months
Behavior and Symptom Identification Scale (BASIS-24)
Measured: monthly for 3 months
Dysfunctional Attitudes Scale
Measured: monthly for 3 months
Quality of Life Index (questionnaire)
Measured: monthly for 3 months
Beck Anxiety Inventory
Measured: monthly for three months
Effort Expenditure for Rewards Task (EEfRT)
Measured: administered once at baseline and once at month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Merakey Behavioral Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992158
- Sponsor's protocol ID
- R34MH108818
- Status last verified
- May 2019
- First submitted
- 1 Dec 2016
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared via the Research Domain Criteria Database (RDoCdb), part of the NIMH Data Archive (NDA). All feasibility and outcome data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Behavioral Activation Trial in Community Mental Health
- ClinicalTrials.gov ID
- NCT02992158
- Acronym / sponsor ID
- R34MH108818
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Merakey Behavioral Health
- Study start
- Mar 2016
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 14 Dec 2016 (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.
The goal of this project is to train community mental health therapists in behavioral activation (BA) treatment for major depressive disorder and then to conduct a study examining the feasibility of evaluating the effectiveness of BA in this setting.
Detailed description
After finalizing a 9-session BA treatment model for major depressive disorder in the Community Mental Health Center (CMHC) setting, the final treatment manual will be used to train clinicians in BA at the CMHC through workshops and training cases.
Upon completion of training and certification of adequate implementation of BA, a total of 80 patients with MDD will be randomly assigned in a 3:1 ratio to 9 sessions of BA or treatment-as-usual (TAU) at the CMHC. Feasibility will be assessed in terms of (1) percent of eligible patients who refuse randomization, (2) percent of patients who complete 9 sessions of BA treatment, (3) percent of BA homework assignments that are completed, (4) percent of monthly assessments obtained, and (5) patient ratings of credibility and alliance in BA treatment. The ability of CMHC therapists to adequately implement BA will be assessed by rating taped sessions on BA adherence and competence scales. In addition to feasibility/acceptability of BA and TAU, this study is designed to test whether theoretically important targets of BA change over the course of BA treatment, and whether such changes are associated with changes in depressive symptoms. The target measures will be assessed at baseline, month 1, month 2, and month 3. To support the potential role of these targets as the mechanisms of change in BA, change in the target variables will be examined in relation to change in depression symptoms. The investigators will also pilot a potential moderator of treatment effects (trait reward processing, as measured at baseline using the Effort-Expenditure for Rewards Task) to include this potential moderator in a subsequent fully-powered study with the long-term goal of identifying the types of patients most responsive to BA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioral activation | Experimental | Behavioral: behavioral activationThe core principles of the BA model are: (1) the key to changing how people feel is helping them change what they do, (2) changes in life can lead to depression, and short-term coping strategies may keep people stuck over time, (3) the clues to figuring out what will be antidepressant for a particular client lie in what precedes and follows the client's important behaviors, (4) structure and scheduling of activities should follow a plan, not a mood, (5) change will be easier when starting small, (6) activities that are naturally reinforcing should be emphasized, (7) the therapist should act as a coach, (8) a problem-solving empirical approach should be emphasized with recognition that all results are useful, (9) patients should be encourages to not just talk, do! (10) possible and actual barriers to activation should be examined. Patients can also receive medications in this arm. |
| treatment-as-usual | Other | Behavioral: treatment-as-usualPatients will receive psychotherapy (and potentially medications) as part of treatment-as-usual provided in the CMHC setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed diagnosis of MDD based on the SCID for DSM-IV (or DSM-V, if available),
- ability to read at least at the 4th grade level,
- willingness to participate in research,
- willingness to be audio recorded (for both therapists and patient- participants)
Key exclusion criteria (4 listed)
- current or past psychotic disorder, seizure disorder, or clinically significant organic pathology
- acute medical problem requiring immediate inpatient treatment,
- current substance abuse or dependence requiring primary referral to substance abuse program,
- significant suicidal risk/ideation requiring immediate referral or suicidal gesture within the last 3 months
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 activation | Behavioural | behavioral activation |
| treatment-as-usualpsychotherapy (and potentially medication) as part of treatment-as-usual provided in a community mental health center | Behavioural | treatment-as-usual |
Primary outcome
percent of eligible patients who refuse randomization
Time frame: assessed at baseline
We will calculate this value based on our records of patient participation in baseline assessments.
percent of patients who complete 9 sessions of BA treatment
Time frame: 12 weeks
We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).
percent of BA homework assignments that are completed
Time frame: 12 weeks
We will calculate this value based on our records of homework assignment completion (tracked weekly by therapist participants and reported to the research staff).
percent of monthly assessments obtained
Time frame: 12 weeks
We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).
Opinions About Treatment questionnaire
Time frame: collected at week 2
This questionnaire measures patient ratings of the credibility of BA treatment.
Brief Alliance Inventory
Time frame: collected at weeks 2, 4, 6, and 8
This questionnaire measures patient ratings of the therapeutic alliance.
10 secondary outcomes
Behavioral Activation for Depression Scale
Time frame: monthly for 3 months
Reward Probability Index
Time frame: monthly for 3 months
Hamilton Rating Scale for Depression
Time frame: monthly for 3 months
Short Form Health Survey (SF-36)
Time frame: monthly for 3 months
Inventory of Depressive Symptomatology
Time frame: monthly for 3 months
Behavior and Symptom Identification Scale (BASIS-24)
Time frame: monthly for 3 months
Dysfunctional Attitudes Scale
Time frame: monthly for 3 months
Quality of Life Index (questionnaire)
Time frame: monthly for 3 months
Beck Anxiety Inventory
Time frame: monthly for three months
Effort Expenditure for Rewards Task (EEfRT)
Time frame: administered once at baseline and once at month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Yes. Data will be shared via the Research Domain Criteria Database (RDoCdb), part of the NIMH Data Archive (NDA). All feasibility and outcome data will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and treatment-as-usual in people with Major Depressive Disorder, run by University of Pennsylvania 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 4 inclusion and 4 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 25 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percent of eligible patients who refuse randomization (time frame: assessed at baseline). The study lists 6 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 25 Mar 2020.