Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432959
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-03-22
Brief Title:
Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Incorporating Positive Affect Into Cognitive Behavioral Therapy for Depression and Dialectical Behavior Therapy for Borderline Personality Disorder and Severe Emotion Dysregulation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAPA
Brief Summary:
In this study the investigators will test whether the incorporation of positive affect promoting activities in treatment sessions improves outcomes in the context of CBT for depression and DBT for problems of emotion dysregulation In clinics focused on each of these treatments the investigators will evaluate these treatments with and without the addition of positive affect promoting activities
Detailed Description:
The investigators will randomize participants to treatment with or without positive affect promoting activities in two samples of adults with emotional disorders participating in a form of cognitive behavioral therapy One sample will be drawn from a clinic providing CBT for depression and the other will be drawn from a clinic providing dialectical behavior therapy
This study is a two-clinic randomized clinical trial Eligible participants will be randomized to standard treatment or standard treatment positive affect promoting activities A total of 50 participants 25 per condition will be randomized in a clinic providing CBT for depression A total of 40 20 per condition will be randomized in a clinic providing CBT for problems of emotion dysregulation Treatment will be provided over 12 weeks in the CBT for depression clinic sample and 24 weeks in the DBT clinic sample At pre-treatment 4-weeks and 12-weeks participants will complete symptoms measures in addition to measures of diagnosis-relevant processes eg rumination personality therapy skills treatment engagement and treatment history Additionally participants and providers will complete measures before and after each therapy session to assess alliance engagement symptoms skills and mood Sessions will be recorded to later code psychotherapy process measures
CBT Clients will participate in a course of CBT for depression CBT consists of a series of structured collaborative sessions with a focus on promoting behavioral activation and helping patients to re-evaluate unduly negative views eg I am worthless Treatment will be informed by the primary treatment manual for CBT of depression Additional cognitive-behavioral treatment procedures for co-occurring conditions may be used as judged appropriate Study personnel will provide treatment and all clinical assessments Clinical supervision will be provided by a licensed psychologist
The protocol for CBT will be to have twice weekly sessions for the first four weeks From week 4 to week 8 the therapist and client will collaboratively decide whether to maintain twice weekly sessions or switch to once weekly sessions From week 8 to week 12 sessions will be weekly Acute treatment will end after 12 weeks Clients will have the option of consulting with their therapist or another therapist which would be likely when a therapist is no longer providing treatment for the study for up to two booster sessions in the six months following their 12-week acute treatment period
DBT Clients will participate in a six-month 24 to 26-week course of DBT DBT consists of weekly individual and group psychotherapy sessions that focus on enhancing skills in mindfulness interpersonal effectiveness emotion regulation and distress tolerance Individual sessions will be approximately one hour per week with optional additional or longer sessions available if deemed clinically necessary and group sessions will be scheduled for two hours once per week At study end participants who wish to continue treatment will be provided with referrals in the community or in the clinic if therapists are available
Study personnel will provide treatment and all clinical assessments Clinical supervision will be provided by a licensed psychologist Recent evidence suggests that 6-months of DBT results in similar outcomes when compared to 12-months of DBT The research group has demonstrated that DBT delivered in a training clinic with this protocol is associated with gains in the domains targeted in the treatment
Positive Affect Promoting Activities Participants will be randomized to either the Positive Affect Promotion Activities PAPA condition or the treatment-as-usual TAU condition Patients in the TAU condition will receive either CBT or DBT as described above Those assigned to the PAPA condition will also receive either CBT or DBT as described above and additionally will be asked to participate in a positive affective promoting activities once per week for the first four weeks of treatment and up to once per session for the remaining sessions Following the first four weeks therapists will work with clients to identify occasions to use positive affect induction procedures as part of between session coping strategies and as method to facilitate subsequent use of additional strategies both in session and between sessions
The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively Given that there are individual differences in the ways that people appraise various stimuli it is important to be flexible in determining what might be an effective positive affect promoting activity for each participant Some examples of positive affect promoting activities that might be incorporated into therapy sessions or between therapy sessions include
Watch videos of animals eg dogs pandas penguins and babies eg laughing discovering
Eat a piece of candy
Recall and describe a past positive experience eg talk about success interest goal pursuit
Describe the positive attributes of the participant
Engage in gratitude practice
Do something nice for someone eg write thank you notes for deployed troops notes of encouragement for children in the hospital volunteer
Listen to music
Draw or create
Practice mindfulness including loving kindness meditations
Take a walk or dance
Watch clips of comedians
Go outside and sit in the sun
View pictures of loved onesanimals
The in-session positive affect activities will last approximately five minutes For the first four weeks the positive affect activities will be completed at the beginning of the session After that therapists will look for opportunities to incorporate positive affect activities at stuck points or before learning a new skill in-session Additionally therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions Participants and therapists will work together to identify activities that reliably lead to feeling joy curiosity pride or love for example Then therapists will work with participants to find opportunities to engage in these activities to help motivate themselves to engage in difficult tasks learn new things or regulate their emotions
This study is a two-clinic randomized clinical trial Eligible participants will be randomized to standard treatment or standard treatment positive affect promoting activities A total of 50 participants 25 per condition will be randomized in a clinic providing CBT for depression A total of 40 20 per condition will be randomized in a clinic providing CBT for problems of emotion dysregulation Treatment will be provided over 12 weeks in the CBT for depression clinic sample and 24 weeks in the DBT clinic sample At pre-treatment 4-weeks and 12-weeks participants will complete symptoms measures in addition to measures of diagnosis-relevant processes eg rumination personality therapy skills treatment engagement and treatment history Additionally participants and providers will complete measures before and after each therapy session to assess alliance engagement symptoms skills and mood Sessions will be recorded to later code psychotherapy process measures
CBT Clients will participate in a course of CBT for depression CBT consists of a series of structured collaborative sessions with a focus on promoting behavioral activation and helping patients to re-evaluate unduly negative views eg I am worthless Treatment will be informed by the primary treatment manual for CBT of depression Additional cognitive-behavioral treatment procedures for co-occurring conditions may be used as judged appropriate Study personnel will provide treatment and all clinical assessments Clinical supervision will be provided by a licensed psychologist
The protocol for CBT will be to have twice weekly sessions for the first four weeks From week 4 to week 8 the therapist and client will collaboratively decide whether to maintain twice weekly sessions or switch to once weekly sessions From week 8 to week 12 sessions will be weekly Acute treatment will end after 12 weeks Clients will have the option of consulting with their therapist or another therapist which would be likely when a therapist is no longer providing treatment for the study for up to two booster sessions in the six months following their 12-week acute treatment period
DBT Clients will participate in a six-month 24 to 26-week course of DBT DBT consists of weekly individual and group psychotherapy sessions that focus on enhancing skills in mindfulness interpersonal effectiveness emotion regulation and distress tolerance Individual sessions will be approximately one hour per week with optional additional or longer sessions available if deemed clinically necessary and group sessions will be scheduled for two hours once per week At study end participants who wish to continue treatment will be provided with referrals in the community or in the clinic if therapists are available
Study personnel will provide treatment and all clinical assessments Clinical supervision will be provided by a licensed psychologist Recent evidence suggests that 6-months of DBT results in similar outcomes when compared to 12-months of DBT The research group has demonstrated that DBT delivered in a training clinic with this protocol is associated with gains in the domains targeted in the treatment
Positive Affect Promoting Activities Participants will be randomized to either the Positive Affect Promotion Activities PAPA condition or the treatment-as-usual TAU condition Patients in the TAU condition will receive either CBT or DBT as described above Those assigned to the PAPA condition will also receive either CBT or DBT as described above and additionally will be asked to participate in a positive affective promoting activities once per week for the first four weeks of treatment and up to once per session for the remaining sessions Following the first four weeks therapists will work with clients to identify occasions to use positive affect induction procedures as part of between session coping strategies and as method to facilitate subsequent use of additional strategies both in session and between sessions
The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively Given that there are individual differences in the ways that people appraise various stimuli it is important to be flexible in determining what might be an effective positive affect promoting activity for each participant Some examples of positive affect promoting activities that might be incorporated into therapy sessions or between therapy sessions include
Watch videos of animals eg dogs pandas penguins and babies eg laughing discovering
Eat a piece of candy
Recall and describe a past positive experience eg talk about success interest goal pursuit
Describe the positive attributes of the participant
Engage in gratitude practice
Do something nice for someone eg write thank you notes for deployed troops notes of encouragement for children in the hospital volunteer
Listen to music
Draw or create
Practice mindfulness including loving kindness meditations
Take a walk or dance
Watch clips of comedians
Go outside and sit in the sun
View pictures of loved onesanimals
The in-session positive affect activities will last approximately five minutes For the first four weeks the positive affect activities will be completed at the beginning of the session After that therapists will look for opportunities to incorporate positive affect activities at stuck points or before learning a new skill in-session Additionally therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions Participants and therapists will work together to identify activities that reliably lead to feeling joy curiosity pride or love for example Then therapists will work with participants to find opportunities to engage in these activities to help motivate themselves to engage in difficult tasks learn new things or regulate their emotions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None