Clinical trial NCT06432959: Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies
Official title: Incorporating Positive Affect Into Cognitive Behavioral Therapy for Depression and Dialectical Behavior Therapy for Borderline Personality Disorder and Severe Emotion Dysregulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Borderline Personality Disorder
Emotion Regulation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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 (e.g., 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 (e.g., "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 (e.g., dogs, pandas, penguins) and babies (e.g., laughing, discovering)
* Eat a piece of candy
* Recall and describe a past positive experience (e.g., talk about success, interest / goal pursuit)
* Describe the positive attributes of the participant
* Engage in gratitude practice
* Do something nice for someone (e.g., 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 ones/animals

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.

Eligibility criteria: Clinic-specific inclusion criteria are as follows. For the clinic providing CBT for depression, participants must meet criteria for a diagnosis of major depressive disorder according to Diagnostic and Statistical Manual-5 (DSM-5). They must also be able to attend in-person sessions or have access to a reliable internet connection to participate in virtual sessions.

For the clinic providing DBT, participants must evidence severe emotion dysregulation defined as (1) meeting criteria for borderline personality disorder (BPD) or (2) elevated indicators of borderline personality pathology defined as average scores of 1.5 on the Personality Inventory for DSM-5 (PID-5) Negative Affectivity scale and 1.25 on the Antagonism scale and/or 1.25 on the Disinhibition scale. They must also be willing and able to attend in-person sessions.

Across both clinics, the following inclusion and exclusion criteria will be applied:

Inclusion Criteria:

1. 18 years old or older
2. residence in the state of Ohio
3. able and willing to give informed consent

Exclusion Criteria:

1. current or past diagnosis of bipolar disorder or a psychotic disorder
2. presence of a psychiatric disorder other than Major Depressive Disorder (MDD) or BPD, if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered (including substance use disorders involving heroin, cocaine, and methamphetamine deemed inappropriate at pre-screening)
3. currently participating in a psychosocial treatment for an emotional disorder, including any individual psychotherapy
4. if on psychiatric medication, no changes to medication regimen (drugs or dosage) in the past month and no intention to modify medication regimen for the next 12 weeks
5. clear indication of secondary gain (e.g., court-ordered treatment)
6. current suicide risk of medical instability (e.g., low weight) to preclude treatment on an outpatient basis

Primary outcomes:
measure: Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report
timeFrame: weekly over 12 weeks
measure: Weekly Change in Positive and Negative Affect Schedule
timeFrame: weekly over 12 weeks
Secondary outcomes:
measure: Weekly Change in Impressions of Skills Scale
timeFrame: weekly over 12 weeks
measure: Change in Credibility/Expectancy Questionnaire
timeFrame: 4 weeks
measure: Weekly Change in Working Alliance Inventory
timeFrame: weekly for 12 weeks
Other outcomes:
measure: Change in Personality Assessment Inventory - Borderline Personality Disorder Subscale
timeFrame: 12 weeks
measure: Change in Personality Inventory for DSM-5 - Faceted Brief Form
timeFrame: 12 weeks
Locations:
city: Columbus
country: United States
facility: Department of Psychology, The Ohio State University
state: Ohio
Study officials:
References: