DepressionSIBSNCT03766360
Bariatric Surgery Study
A study testing Functional Analytical Psychotherapy (FAP) in people with Depression and Quality of Life, run by University of Washington at 1 site in United States.
Trial summary
The current study proposes an open clinical trial to investigate the effectiveness of a social functioning intervention on bariatric surgery outcomes and depression. The treatment will be administered in a group format over 10 weekly/biweekly sessions and will take place at the University of Washington Weight Loss… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Quality of Life, Interpersonal Relations
- What is being tested?
- Functional Analytical Psychotherapy (FAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2019to Dec 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
- Older than 18
- Speak English as a primary language
- Had Bariatric Surgery in the past 6-24 months (bypasses (Roux-en-Y) or sleeves)
- Yes to one or both of the first two PHQ-9 Questions
- Not pregnant
- Not traveling anywhere in the next 6 months
- No surgeries scheduled in the next 12 months
Who cannot join
- No exclusion criteria are utilized in the present study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Loss Management Center at UWMC-Roosevelt
Seattle, Washington, 98105
Ruth Foster-Koth, MA, 206-598-1752, rfosterk@uw.edu
About this study
Official title: A Social Functioning Intervention to Target Depression Post Bariatric Surgery
The current study proposes an open clinical trial to investigate the effectiveness of a social functioning intervention on bariatric surgery outcomes and depression. The treatment will be administered in a group format over 10 weekly/biweekly sessions and will take place at the University of Washington Weight Loss Management Clinic (WLMC) at the Roosevelt Clinic location. Effects of the intervention will be measured with self-report questionnaires and by self-report of behaviors outside of assessment sessions (via questionnaires and self-report of adherence to treatment). Data collection will occur at specific time points including before treatment, after treatment, and two months after treatment.
Read the detailed description
As of 2009, 344,000 bariatric procedures were performed annually . Although some studies report depressive symptoms decrease in the 6 months after bariatric surgery, there is growing body of literature suggesting there exists a subgroup of patients whose depressive symptoms worsen after surgery and the likelihood of developing depressive symptoms increases longitudinally. Depression can be an indicator of an increased risk of self-harm and additional studies have found that the risk of suicide may increase post bariatric surgery compared to obese individuals who have not undergone surgery.
Research supports that psychosocial factors contribute to successful postoperative outcomes. Functional Analytic Psychotherapy shows potential to impact social variables that may be relevant to bariatric surgery outcomes including depression. In this context, FAP aims to improve interpersonal relationships through experientially teaching skills intended to increase social connection. FAP also seeks to increase awareness, which includes the ability to view interpersonal interactions from multiple perspectives, allowing new interpersonal skills to emerge.
The present study seeks to evaluate the use of a FAP group to enhance interpersonal relating with a sample of post-bariatric surgery patients. Measures will be collected on quality of life and variables involved in interpersonal connectedness.
- Conditions
- Depression, Quality of Life, Interpersonal Relations
- Being tested
- Functional Analytical Psychotherapy (FAP)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Analytical Psychotherapy (FAP)Behavioural
The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.
| Study group | Role | What they receive |
|---|---|---|
| FAP Intervention Group | Experimental | All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments. Receives: Behavioral: Functional Analytical Psychotherapy (FAP) |
| Control Group | No intervention | The clients in the control group will take their assessments at the same time as those in the FAP intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Measured: Baseline
Patient Health Questionnaire-9 (PHQ-9)
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
Patient Health Questionnaire-9 (PHQ-9)
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Measured: Follow Up (3 Months after Intervention)
Secondary outcomes (24)
World Health Organization Quality of Life
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
Measured: Baseline
World Health Organization Quality of Life
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
World Health Organization Quality of Life
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
Measured: Follow Up (3 Months after Intervention)
Drug Abuse Screening Test
a sensitive screening instrument for the abuse of drugs other than alcohol
Measured: Baseline
Drug Abuse Screening Test
a sensitive screening instrument for the abuse of drugs other than alcohol
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
Drug Abuse Screening Test
a sensitive screening instrument for the abuse of drugs other than alcohol
Measured: Follow Up (3 Months after Intervention)
Paffenbarger Physical Activity Questionnaire
asks participants about their current and previous exercise habits
Measured: Baseline
Paffenbarger Physical Activity Questionnaire
asks participants about their current and previous exercise habits
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
Paffenbarger Physical Activity Questionnaire
asks participants about their current and previous exercise habits
Measured: Follow Up (3 Months after Intervention)
Proximal Change Variables
assesses participant's eating habits as well as tobacco and alcohol use
Measured: Baseline
Proximal Change Variables
assesses participant's eating habits as well as tobacco and alcohol use
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
Proximal Change Variables
assesses participant's eating habits as well as tobacco and alcohol use
Measured: Follow Up (3 Months after Intervention)
Weight Control Questionnaire
asks participants to report if they have ever used any weight control practices
Measured: Baseline
Weight Control Questionnaire
asks participants to report if they have ever used any weight control practices
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
Weight Control Questionnaire
asks participants to report if they have ever used any weight control practices
Measured: Follow Up (3 Months after Intervention)
Fear of Intimacy Scale (FIS)
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Measured: Baseline
Fear of Intimacy Scale (FIS)
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
Fear of Intimacy Scale (FIS)
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Measured: Follow Up (3 Months after Intervention)
Social Support Survey
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Measured: Baseline
Social Support Survey
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
Social Support Survey
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Measured: Follow Up (3 Months after Intervention)
University of California, Los Angeles Loneliness Scale
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
Measured: Baseline
University of California, Los Angeles Loneliness Scale
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
Measured: Post Intervention (Approximately 12 Weeks from Baseline)
University of California, Los Angeles Loneliness Scale
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
Measured: Follow Up (3 Months after Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Kanter, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766360
- Sponsor's protocol ID
- STUDY00005196
- Acronym
- SIBS
- Status last verified
- Dec 2018
- First submitted
- 27 Nov 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
PubMed 19272486Switzer, N.J., Debru, E., Church, N. et al. Curr Cardiovasc Risk Rep (2016) 10: 12. https://doi.org/10.1007/s12170-016-0492-7
Mitchell JE, Crosby R, de Zwaan M, Engel S, Roerig J, Steffen K, Gordon KH, Karr T, Lavender J, Wonderlich S. Possible risk factors for increased suicide following bariatric surgery. Obesity (Silver Spring). 2013 Apr;21(4):665-72. doi: 10.1002/oby.20066.
PubMed 23404774Sarwer DB, Moore RH, Spitzer JC, Wadden TA, Raper SE, Williams NN. A pilot study investigating the efficacy of postoperative dietary counseling to improve outcomes after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):561-8. doi: 10.1016/j.soard.2012.02.010. Epub 2012 Mar 21.
PubMed 22551576Kohlenberg, R. J., & Tsai, M. (1991). Functional analytic psychotherapy: Creating intense and curative therapeutic relationships. New York, NY, US: Plenum Press. http://dx.doi.org/10.1007/978-0-387-70855-3
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Social Functioning Intervention to Target Depression Post Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03766360
- Acronym / sponsor ID
- SIBS / STUDY00005196
- Conditions
- Depression, Quality of Life, Interpersonal Relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Dec 2018 (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 current study proposes an open clinical trial to investigate the effectiveness of a social functioning intervention on bariatric surgery outcomes and depression. The treatment will be administered in a group format over 10 weekly/biweekly sessions and will take place at the University of Washington Weight Loss Management Clinic (WLMC) at the Roosevelt Clinic location. Effects of the intervention will be measured with self-report questionnaires and by self-report of behaviors outside of assessment sessions (via questionnaires and self-report of adherence to treatment). Data collection will occur at specific time points including before treatment, after treatment, and two months after treatment.
Detailed description
As of 2009, 344,000 bariatric procedures were performed annually . Although some studies report depressive symptoms decrease in the 6 months after bariatric surgery, there is growing body of literature suggesting there exists a subgroup of patients whose depressive symptoms worsen after surgery and the likelihood of developing depressive symptoms increases longitudinally. Depression can be an indicator of an increased risk of self-harm and additional studies have found that the risk of suicide may increase post bariatric surgery compared to obese individuals who have not undergone surgery.
Research supports that psychosocial factors contribute to successful postoperative outcomes. Functional Analytic Psychotherapy shows potential to impact social variables that may be relevant to bariatric surgery outcomes including depression. In this context, FAP aims to improve interpersonal relationships through experientially teaching skills intended to increase social connection. FAP also seeks to increase awareness, which includes the ability to view interpersonal interactions from multiple perspectives, allowing new interpersonal skills to emerge.
The present study seeks to evaluate the use of a FAP group to enhance interpersonal relating with a sample of post-bariatric surgery patients. Measures will be collected on quality of life and variables involved in interpersonal connectedness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAP Intervention Group | Experimental | Behavioral: Functional Analytical Psychotherapy (FAP)All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments. |
| Control Group | No intervention | –The clients in the control group will take their assessments at the same time as those in the FAP intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Older than 18
- Speak English as a primary language
- Had Bariatric Surgery in the past 6-24 months (bypasses (Roux-en-Y) or sleeves)
- Yes to one or both of the first two PHQ-9 Questions
- Not pregnant
Key exclusion criteria (1 listed)
- No exclusion criteria are utilized in the present study.
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 |
|---|---|---|
| Functional Analytical Psychotherapy (FAP)The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning. | Behavioural | FAP Intervention Group |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Follow Up (3 Months after Intervention)
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
24 secondary outcomes
World Health Organization Quality of Life
Time frame: Baseline
World Health Organization Quality of Life
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
World Health Organization Quality of Life
Time frame: Follow Up (3 Months after Intervention)
Drug Abuse Screening Test
Time frame: Baseline
Drug Abuse Screening Test
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
Drug Abuse Screening Test
Time frame: Follow Up (3 Months after Intervention)
Paffenbarger Physical Activity Questionnaire
Time frame: Baseline
Paffenbarger Physical Activity Questionnaire
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
Paffenbarger Physical Activity Questionnaire
Time frame: Follow Up (3 Months after Intervention)
Proximal Change Variables
Time frame: Baseline
Proximal Change Variables
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
Proximal Change Variables
Time frame: Follow Up (3 Months after Intervention)
Weight Control Questionnaire
Time frame: Baseline
Weight Control Questionnaire
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
Weight Control Questionnaire
Time frame: Follow Up (3 Months after Intervention)
Fear of Intimacy Scale (FIS)
Time frame: Baseline
Fear of Intimacy Scale (FIS)
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
Fear of Intimacy Scale (FIS)
Time frame: Follow Up (3 Months after Intervention)
Social Support Survey
Time frame: Baseline
Social Support Survey
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
Social Support Survey
Time frame: Follow Up (3 Months after Intervention)
University of California, Los Angeles Loneliness Scale
Time frame: Baseline
University of California, Los Angeles Loneliness Scale
Time frame: Post Intervention (Approximately 12 Weeks from Baseline)
University of California, Los Angeles Loneliness Scale
Time frame: Follow Up (3 Months after Intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Background: PubMed 19272486Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
- BackgroundSwitzer, N.J., Debru, E., Church, N. et al. Curr Cardiovasc Risk Rep (2016) 10: 12. https://doi.org/10.1007/s12170-016-0492-7
- Background: PubMed 23404774Mitchell JE, Crosby R, de Zwaan M, Engel S, Roerig J, Steffen K, Gordon KH, Karr T, Lavender J, Wonderlich S. Possible risk factors for increased suicide following bariatric surgery. Obesity (Silver Spring). 2013 Apr;21(4):665-72. doi: 10.1002/oby.20066.
- Background: PubMed 22551576Sarwer DB, Moore RH, Spitzer JC, Wadden TA, Raper SE, Williams NN. A pilot study investigating the efficacy of postoperative dietary counseling to improve outcomes after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):561-8. doi: 10.1016/j.soard.2012.02.010. Epub 2012 Mar 21.
- BackgroundKohlenberg, R. J., & Tsai, M. (1991). Functional analytic psychotherapy: Creating intense and curative therapeutic relationships. New York, NY, US: Plenum Press. http://dx.doi.org/10.1007/978-0-387-70855-3
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Analytical Psychotherapy (FAP) in people with Depression and Quality of Life, 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 7 inclusion and 1 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 6 Dec 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Kanter, PhD (206-685-7462, jonkan@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT03766360, which also lists 5 linked publications.
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 6 Dec 2018; AzTrials last refreshed its copy on 27 Oct 2026.