Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies — PAPA  

Depression Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Depression
• Emotion Regulation
• Personality Disorders

• NCT number: NCT06432959
• Study type: Interventional
• Source: Ohio State University
• Contact: Jennifer S Cheavens, PhD
• Phone: 614-247-6733
• Email: cheavens.1@osu.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Completion date: July 1, 2024