Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies

NCT06432959 | Completed

• 1 other identifier: 2022B0257
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Borderline Personality Disorder; Emotion Regulation

Outcome Measures

Primary Outcomes (2)

• Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report

  16 item self-report assessment of symptoms of depression with each item scored on a 0-3 scale. Higher scores indicate more severe symptoms of depression.

  weekly over 12 weeks

• Weekly Change in Positive and Negative Affect Schedule

  20 item self-rated assessment of positive and negative affect in the moment with each item scored on a 1-9 scale. Higher scores reflect higher levels of affect.

  weekly over 12 weeks

Secondary Outcomes (3)

• Weekly Change in Impressions of Skills Scale

  weekly over 12 weeks

• Change in Credibility/Expectancy Questionnaire

  4 weeks

• Weekly Change in Working Alliance Inventory

  weekly for 12 weeks

Other Outcomes (2)

• Change in Personality Assessment Inventory - Borderline Personality Disorder Subscale

  12 weeks

• Change in Personality Inventory for DSM-5 - Faceted Brief Form

  12 weeks

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Participants in the TAU arm will receive either Cognitive Behavioral Therapy (CBT) or Dialectical Behavior Therapy (DBT), depending on eligibility. CBT will be twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to have once or twice weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. In DBT, 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.

Behavioral: Psychotherapy

TAU + Positive Affect Promoting Activities

EXPERIMENTAL

Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in positive affective promoting activities. In session positive affective promoting activities are to be provided once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Clients will also be encouraged to utilize positive affect promoting activities between sessions.

Behavioral: Psychotherapy, Positive Affect Promoting Activities; Behavioral: Psychotherapy

Interventions

Psychotherapy, Positive Affect Promoting Activities BEHAVIORAL

The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Some examples of positive affect promoting activities are: * Watch videos of animals and babies * Eat a piece of candy * Recall and describe a past positive experience * Describe the positive attributes of the participant * Engage in gratitude practice * Do something nice for someone 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.

TAU + Positive Affect Promoting Activities

Psychotherapy BEHAVIORAL

Meet with treatment providers individually or in group to learn skills to address symptoms associated with depression and emotion dysregulation

TAU + Positive Affect Promoting Activities; Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• years old or older
• residence in the state of Ohio
• able and willing to give informed consent
• current or past diagnosis of bipolar disorder or a psychotic disorder
• 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)
• currently participating in a psychosocial treatment for an emotional disorder, including any individual psychotherapy
• 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
• clear indication of secondary gain (e.g., court-ordered treatment)
• current suicide risk of medical instability (e.g., low weight) to preclude treatment on an outpatient basis

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Department of Psychology, The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Depression; Borderline Personality Disorder; Emotional Regulation

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personality Disorders; Mental Disorders; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be randomized to treatment as usual (i.e., CBT or DBT) or treatment-as-usual plus positive affect promoting activities (i.e., CBT with PAPA, DBT with PAPA). Randomization will occur within clinic (i.e., one clinic provides CBT, the other provides DBT). In the clinic providing CBT for depression, a total of 50 participants will be randomized (25 each to CBT or CBT with PAPA). In the clinic providing DBT, 40 participants will be randomized (20 each to CBT or CBT with PAPA). Given the treatments under investigation, neither the interventionist nor the participant could be kept unaware of condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 29, 2024
• Study Start: September 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)