Major Depressive DisorderNCT06336616
Getting Out of the House: Using Behavioral Activation to Increase Community Participation
A study testing Behavior Activation in people with Major Depressive Disorder and Schizo Affective Disorder, run by Temple University at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness. The overall objective of this study is to increase engagement in meaningful activities and community participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Schizo Affective Disorder, Schizophrenia
- What is being tested?
- Behavior Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- must respond yes to three questions related to their history with serious mental illness (see below);
- a score of 8 or higher on the Center for Epidemiologic Studies Depression Scale - Revised -10 (CES-D-R-10)
- have Internet access;
- be willing to carry a cell phone with a GPS tracking application;
- indicate that they would like to participate more in the community;
- be able to communicate in English;
Show all 12Show fewer
- be over the age of 18; and
- and be available on for the day and time (i.e., Monday, Tuesday, Wednesday, Thursday, or Friday) the intervention is scheduled for each cohort.
- Questions related to history with serious mental illness:
- "Have you ever been told by a psychiatrist or other mental health professional that you have major depression, bipolar disorder, manic depression, schizophrenia or schizoaffective disorder?",
- "Have you ever been hospitalized for this mental health or emotional problem?", and
- "Has this mental health or emotional problem substantially interfered with or limited your ability to participate in any major life activities such as work, school, recreation, social activities, religious activities, family relationships, or caring for yourself?" Answering yes to these 3 questions would be indicative of a lifetime serious mental illness.
Who cannot join
- those who are unable to give informed consent
- those who report having a legal guardian -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Getting Out of the House: A Behavioral Activation Approach to Support Community Participation With Individuals With Serious Mental Illness
The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness.
The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows:
Read more
- To determine if the intervention leads to increases the frequency and variety of activities.
- To determine if the intervention leads to increases in community mobility.
- To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.
- To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).
Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period.
For data collection, participants will also be asked to:
- Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;
- Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and
- Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.
The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group.
- Being tested
- Behavior Activation
- Keywords
- serious mental illness
- Medical subject headings
- Depressive Disorder, Major, Psychotic Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior ActivationBehavioural
Also called SWITCH
Participants will be taught to identify meaningful activities, set goals, use environmental cues, self-reward, to identify barriers and facilitators, and learn new skills to support them to develop self-management skills and new habits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | All participants will receive an online behavioral intervention for 10 weeks, followed by monthly maintenance sessions for 3 months. Receives: Behavioral: Behavior Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Logs
The activity logs are open ended forms in which participants are asked to enter in the primary activities they did in a day (e.g., work), the amount of time they did if for (e.g., 2 hours), how effortful it was on a scale of 1-5, and what their mood was before, during, and after the activity on a scale of 1-5. A higher score on effort (5) is indicative of greater effort, and a higher score ono mood indicates a better or more positive mood. Activities type will be analyzed qualitatively.
Measured: administered 26 times: 1 time per week for 26 weeks.
Participation Checklist
Participants will be asked to state whether they did an activity from a list of 20 items. Response options include yes or no. A greater number of "yes" responses will indicate a greater level of participation that week.
Measured: administered 26 times: 1 time per week for 26 weeks
Behavior Activation for Depression Scale
The behavior activation depression scale measures related to activity, social interaction, and negative thinking or feelings There are 25 statements measured on a 6-point Likert scale varying from not at all to completely. The range of scores is 0 to 54, with high scores representing higher behavioral activation.activities
Measured: administered 26 times: 1 time per week for 26 weeks
Temple University Community Participation Measure
Measures engagement in 29 participation areas, if those areas are important to them, how often they did them and if it was enough, not enough, or too much. Higher reported frequency across a greater number of areas indicates higher rates of participation. Higher number of activities reported as being important and done enough indicate greater sufficiency of participation.
Measured: administered 3 times: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the intervention
Community Mobility (Global Positioning System; GPS)
Participants will carry a cellphone that will track their movements in the community using a GPS app. GPS data shows movements in the community in distance traveled in kilometers. This will be analyzed as total distance traveled.
Measured: administered 3 times for 2 weeks: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the end of the intervention
Community Mobility (Global Positioning System; GPS)
Participants will carry a cellphone that will track their movements in the community using a GPS app. GPS data shows locations participants go to in the community with GPS coordinates. This will be analyzed as the number of locations visited.
Measured: administered 3 times for 2 weeks: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the end of the intervention
Secondary outcomes (13)
Lerman Quality of Life Interview
This measure assesses the overall perceived quality of life. There are 11 items across three domains: community inclusion, holistic health and functioning, and human and legal rights. The statement "[If homeless or in jail, the place where you typically sleep at night?]" will be removed from Q5 the questionnaire as it is not relevant to our study participants. Response options vary from terrible to delighted on a 7-point scale. Responses closer to 7 (delighted) indicate greater perceived quality of life and responses closer to 1 (terrible) indicate lower perceived quality of life. The scores will be summed across questions and higher scores indicate better perceived quality of life.
Measured: administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later
New General Self-Efficacy Scale (adapted to participation)
This is a self-report measure of self-efficacy or perceived ability to participate in the community. There are 10 items with 4 responses options ranging from not at all (1) to exactly true (4). Total scores can range from 10-40 with a higher score indicated greater self-efficacy
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Recovery Assessment Scale (RAS)
Three subscale from the RAS will be used: 1) reliance on others, 2) confidence and hope, and 3) willingness to ask for help. Responses range from strongly disagree (1) to strongly agree (5). Scores can range from 16-80 with higher scores indicating greater recovery, reliance on others, confidence, and willingness to ask for help.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Activity Assessment Scale
Measures motivation, ease, pleasure, and satisfaction related to behaviors that are precursors to participation (e.g., planning transportation and outings). Each subscale (e.g., motivation) is measured on a 4-point scale from "not at all" to "extremely." Each subscale is scored separately with scores ranging from 5 to 20. Higher scores indicate higher level of each subscale (e.g. ease).
Measured: administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later
Capabilities and Opportunities for Participation Questionnaire
Includes 8 statements related to capabilities tied to participation (e.g., I feel comfortable taking public transportation) and 14 related to opportunities tied to participation (e.g., I have access to materials or equipment to participate). All items are measure on a scale of 1-6 from strongly disagree to strongly agree. For 17 of the 22 items higher scores indicate greater capabilities and opportunities and for 5 of the 22 lower scores indicate greater capabilities and opportunities.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Self-Control and Self-Management Scale
The 16-item instrument includes statements about self-control and self-management. The scoring is on a 6-point Likert scale, and the anchors adopted for score reporting are 1 to 6. Thus, the possible total scale score range is 16-96 with higher scores indicating greater self-management and self-control.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Habit Strength Scale
This was modified to measures habit strength for participation rather than moderate to vigorous activity. The measure consists of 17 items or statements with response options ranging from 1-6 on a 6-point Likert scale from strongly disagree to strongly agree. Possible scores range from 17 to 102 with higher scores indicating greater habit strength.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
University of California Los Angeles Loneliness Scale
These 3 questions are only being given to people who report having a mental illness. The questions related to how often people feel socially isolated or lonely. Response options range from 1) hardly ever, 2) some of the time, and 3) often. Responses (3) indicate increased loneliness and more "hardly ever" responses indicate less loneliness.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Lehman Quality of LIfe (QOL) Interview Social Relations sub scale
This subscale is an indicator of social relationships and networks. It contains 6-items rated on a 5-point scale and 6 additional measures on a 7-point scale. Higher scores on the items indicate better social relationships.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Hopkins Symptoms Checklist
This measure assesses primary symptom dimensions over the past week using a 25-item assessment with a 4-point Likert scale (0 = not at all to 4 = extremely). Higher scores indicate higher levels of symptoms. Separate averages of depression and anxiety items are calculated and a total score represents the mean of the total 25 items.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
The Life Engagement Test
The measure assesses purpose in life. There are 6 items/statements with response options on a 5-point Likert scale ranging from 1-5, (1= "Strongly disagree" and 5 = "Strongly agree"). Scores for each question are summed with a range of scores from 6 to 30. Higher scores indicate greater levels of purpose in life.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
The University of Rhode Island Change Assessment Measure (URICA)
The measure contains 28 items with statements related to readiness to change. The readiness score is determined by calculating the means for precontemplation, contemplation, action, and the maintenance responses. The mean from the precontemplation is then subtracted from the summation of the means of the other three stages. 8 or lower classified as people in Precontemplation, 8-11 classified as people in Contemplation, and 11-14 classified as people in Preparation or Action.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Reward Probability Index
The 20-item self-report measure designed assess the likelihood of environmental rewards. Each question is scored on a scale of 1-4 from strongly disagree to strongly agree. Higher scores on 11 of the 20 items and lower scores on 9 of the items indicate a greater likelihood of environmental reward.
Measured: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Feb 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336616
- Sponsor's protocol ID
- 31164
- Status last verified
- Jun 2026
- First submitted
- 27 Feb 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting Out of the House: A Behavioral Activation Approach to Support Community Participation With Individuals With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT06336616
- Acronym / sponsor ID
- 31164
- Keywords
- serious mental illness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- 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 study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness.
The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows:
- To determine if the intervention leads to increases the frequency and variety of activities.
- To determine if the intervention leads to increases in community mobility.
- To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention.
- To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life).
Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period.
For data collection, participants will also be asked to:
- Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period;
- Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and
- Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation.
The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Behavior ActivationAll participants will receive an online behavioral intervention for 10 weeks, followed by monthly maintenance sessions for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- must respond yes to three questions related to their history with serious mental illness (see below);
- a score of 8 or higher on the Center for Epidemiologic Studies Depression Scale - Revised -10 (CES-D-R-10)
- have Internet access;
- be willing to carry a cell phone with a GPS tracking application;
- indicate that they would like to participate more in the community;
Key exclusion criteria (2 listed)
- those who are unable to give informed consent
- those who report having a legal guardian -
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 |
|---|---|---|
| Behavior ActivationAlso: SWITCHParticipants will be taught to identify meaningful activities, set goals, use environmental cues, self-reward, to identify barriers and facilitators, and learn new skills to support them to develop self-management skills and new habits. | Behavioural | Intervention group |
Primary outcome
Activity Logs
Time frame: administered 26 times: 1 time per week for 26 weeks.
The activity logs are open ended forms in which participants are asked to enter in the primary activities they did in a day (e.g., work), the amount of time they did if for (e.g., 2 hours), how effortful it was on a scale of 1-5, and what their mood was before, during, and after the activity on a scale of 1-5. A higher score on effort (5) is indicative of greater effort, and a higher score ono mood indicates a better or more positive mood. Activities type will be analyzed qualitatively.
Participation Checklist
Time frame: administered 26 times: 1 time per week for 26 weeks
Participants will be asked to state whether they did an activity from a list of 20 items. Response options include yes or no. A greater number of "yes" responses will indicate a greater level of participation that week.
Behavior Activation for Depression Scale
Time frame: administered 26 times: 1 time per week for 26 weeks
The behavior activation depression scale measures related to activity, social interaction, and negative thinking or feelings There are 25 statements measured on a 6-point Likert scale varying from not at all to completely. The range of scores is 0 to 54, with high scores representing higher behavioral activation.activities
Temple University Community Participation Measure
Time frame: administered 3 times: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the intervention
Measures engagement in 29 participation areas, if those areas are important to them, how often they did them and if it was enough, not enough, or too much. Higher reported frequency across a greater number of areas indicates higher rates of participation. Higher number of activities reported as being important and done enough indicate greater sufficiency of participation.
Community Mobility (Global Positioning System; GPS)
Time frame: administered 3 times for 2 weeks: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the end of the intervention
Participants will carry a cellphone that will track their movements in the community using a GPS app. GPS data shows movements in the community in distance traveled in kilometers. This will be analyzed as total distance traveled.
Community Mobility (Global Positioning System; GPS)
Time frame: administered 3 times for 2 weeks: at baseline, within 1 month following the 10 weeks of weekly meetings, and 3 months later within 1 month following the end of the intervention
Participants will carry a cellphone that will track their movements in the community using a GPS app. GPS data shows locations participants go to in the community with GPS coordinates. This will be analyzed as the number of locations visited.
13 secondary outcomes
Lerman Quality of Life Interview
Time frame: administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later
New General Self-Efficacy Scale (adapted to participation)
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Recovery Assessment Scale (RAS)
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Activity Assessment Scale
Time frame: administered 3 times: at baseline, within 1 month following 10 week intervention, and within 1 month following the maintenance period 3 months later
Capabilities and Opportunities for Participation Questionnaire
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Self-Control and Self-Management Scale
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Habit Strength Scale
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
University of California Los Angeles Loneliness Scale
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Lehman Quality of LIfe (QOL) Interview Social Relations sub scale
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Hopkins Symptoms Checklist
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
The Life Engagement Test
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
The University of Rhode Island Change Assessment Measure (URICA)
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Reward Probability Index
Time frame: administered 3 times: at baseline, within 1 month following the 10 week intervention, and within 1 month following the maintenance period 3 months later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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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 Behavior Activation in people with Major Depressive Disorder and Schizo Affective Disorder, run by Temple University 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 12 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Activity Logs (time frame: administered 26 times: 1 time per week for 26 weeks.). 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 22 Jun 2026.