## Protocol Section
### Identification Module
**NCT ID:** NCT05199779

**Brief Title:** Single Session Intervention for Building Self-Compassion Habits-RCT

**Official Title:** A Single Session Intervention Leveraging an Ultra-Brief Exercise for Building Self-Compassion Habits-A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 2021-12-14924
#### Organization
**Class:** OTHER
**Full Name:** University of California, Berkeley
### Status Module
#### Completion Date
**Date:** 2022-04-29

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2022-05-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-04-29

**Type:** ACTUAL

#### Start Date
**Date:** 2022-02-13

**Type:** ACTUAL

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2022-01-20
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-05
**Study First Submit QC Date:** 2022-01-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, Berkeley

#### Responsible Party

**Investigator Affiliation:** University of California, Berkeley

**Investigator Full Name:** Allison Harvey

**Investigator Title:** Professor of Clinical Psychology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study will test a single session self-compassion intervention that leverages an ultra-brief contemplative exercise. It will evaluate the effect of this intervention on psychopathology, stress, growth mindset, positive affect, self-compassion and the automaticity of self-compassion, as well as the relationships between these constructs and the automaticity of self-compassion. The participants will be undergraduate students at a large public university.

**Detailed Description:** The broad aims of the proposed research is to examine the outcomes of a single session psychological intervention and to further understand processes and factors associated with habit formation. undergraduate students at a large university will be randomly assigned to a self-compassion intervention (SCI), or an active control (AC), and complete assessments at baseline (pre-treatment) and 4 weeks later (post-treatment).

The investigators seek to examine the following: (A1) Determine whether the group who receives the SCI, relative to the AC, will experience increased self-compassion, growth mindset and positive affect, as well as reduced stress and psychopathology. (A2) Evaluate whether the SCI group shows greater increases in automaticity of self-compassion compared to the AC pre- to post-treatment. (A3) Assess whether greater pre- to post-treatment increases in automaticity of self-compassionate are associated with increased self-compassion, growth mindset, and positive affect, as well as reductions in stress and psychopathology.

The investigators hypothesize the following: (H1) SCI will promote greater increases in self-compassion, growth mindset, and positive affect, as well as greater reductions in stress and psychopathology from pre- to post-treatment, relative to AC. (H2) The SCI group will show greater increases in the automaticity of self-compassion than AC from pre- to post-treatment. (H3) Greater increases in the automaticity of self-compassion from pre- to post-treatment will be predicted by greater increases in self-compassion, growth mindset, and positive affect, as well as greater decreases in psychopathology and stress, from pre- to post treatment. To further understand the results obtained, the investigators will evaluate participants' frequency, adherence, and impressions of using the intervention.

### Conditions Module

**Conditions:**

- Transdiagnostic Psychopathology

**Keywords:**

- Self-Compassion

- Habits

- Transdiagnostic

- Intervention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Participants will be randomized to the SCI or AC control using the randomizer elements in Qualtrics.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** To reduce bias in the assessments, none of the constructs of interest to this study (e.g., "stress", "self-compassion") will be included in the language used to describe the intervention or in any materials used to advertise the study. Study participants will be told they are participating in a study on "fostering emotional well-being". No further information about the intervention will be provided.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 135

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** First, participants will be taught to implement a 20-second self-compassion induction via video recording. Second, participants will be taught to choose a cue that will precede their daily use of the self-compassion induction. Participants will document the cue they chose, and will be emailed a record of their selected cue, along with the recording and transcript of the self-compassion induction that they can refer back to for reference. Third, participants will be asked to use the self-compassion induction as much as they can and at least once during their daily routine following exposure to their chosen cue.

**Intervention Names:**

- Behavioral: Single Session Intervention Leveraging an Ultra-Brief Self-Compassion Exercise

**Label:** Self-Compassion Intervention (SCI)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The active control will receive the same procedures as described above, except for receiving a different video containing different instructions describing a finger-tapping exercise. The videos will be virtually identical in length, quality, instructor/their outfit, and lighting.

**Intervention Names:**

- Behavioral: Finger-Tapping Active Control

**Label:** Finger-Tapping Active Control (AC)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Self-Compassion Intervention (SCI)

**Description:** This 20-second contemplative exercise includes draws from the science of habit formation and includes elements of self-soothing touch, somatic experiencing, and mindful self-compassion.

**Name:** Single Session Intervention Leveraging an Ultra-Brief Self-Compassion Exercise

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Finger-Tapping Active Control (AC)

**Description:** This 20-second finger tapping exercise involves touching each finger to the thumb on one hand and repeating for twenty seconds. This intervention was designed to control for the potential effect of assessment on outcomes, the effect of having an activity to do for the duration of the intervention (4 weeks), regression to the mean, time, or other nonspecific factors.

**Name:** Finger-Tapping Active Control

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Number of times practiced self-compassion exercise per day. 1 item.

**Measure:** Practice Frequency

**Time Frame:** Assessed at Post-treatment (week 4)

**Description:** Number of days in the past two months that did not practice the exercise at all. 1 item.

**Measure:** Overall Practice Frequency

**Time Frame:** Assessed at Post-treatment (week 4)

**Description:** 1 item, number of days practiced exercise but for less than 10 seconds.

**Measure:** Practice Duration

**Time Frame:** Assessed at Post-treatment (week 4)

**Description:** 10 items on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item were summed to give a total score, with higher scores indicating higher levels of reported adherence.

**Measure:** Adherence Report Scale

**Time Frame:** Assessed at Post-treatment (week 4)

**Description:** Exploratory qualitative assessment.

**Measure:** General impressions of exercise

**Time Frame:** Assessed at Post-treatment (week 4)

#### Primary Outcomes

**Description:** Sum of 20-item, 5-point response scale. Scores can range from 20 to 100 (Higher score means higher compassion for self).

Sub-scale items included.

**Measure:** Sussex-Oxford Compassion for the Self Scale (SOCS-S)

**Time Frame:** Change from baseline to post-treatment (week 4)

**Description:** 8 items. 6-point response scale (1 = strongly agree; 6 = strongly disagree) Higher scores indicate a more growth mindset. Lower scores indicate a more fixed mindset.

Score is sum of all items, with Q3, Q5, Q7, and Q8 reverse-scored. The formula for reverse-scoring an item is: ((Number of scale points) + 1) - (Respondent's answer)

**Measure:** Kind of Person' Implicit Theory Scale (KOPITS)

**Time Frame:** Change from baseline to post-treatment (week 4)

**Description:** 10 items with a 6 point response scale. Positive affect sub-scale only.

Scoring:

Positive Affect Score: Sum score of 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores range from 10 - 50. Higher scores = higher levels of positive affect.

Negative Affect Score: Sum score of 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores range from 10 - 50. Lower scores = lower levels of negative affect.

**Measure:** Positive and Negative Affect Schedule (PANAS)

**Time Frame:** Change from baseline to post-treatment (week 4)

**Description:** 10 items, 5 point response scale (from 0 = Never to 4 = Very Often)

Scoring: Reverse score (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) items 4, 5, 7, \& 8 and then summing across all scale items.

**Measure:** 10-item Perceived-Stress Scale (PSS-10)

**Time Frame:** Change from baseline to post-treatment (week 4)

**Description:** 22 items (suicidality item Q11 removed). 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day).

**Measure:** DSM-5 Cross-Cutting Measure (DSM-XC)

**Time Frame:** Change from baseline to post-treatment (week 4)

**Description:** 20 items. 1-9 scale.

**Measure:** Self-Report Behavioral Automaticity Index for Self-Compassion

**Time Frame:** Change from baseline to post-treatment (week 4)

#### Secondary Outcomes

**Description:** 9 items. 1-5 scale. Scores range from 9-45. Mindfulness, common humanity, and self-kindness sub-scales only.

**Measure:** State Self-Compassion Scale Long Form (SSCS-L)

**Time Frame:** Change from pre-induction to post-induction at baseline and at post-treatment (week 4). Change in pre to post-induction changes in state self-compassion from baseline to post-treatment (week 4)

**Description:** 4 items. 1-9 scale.

**Measure:** Self-Report Behavioral Automaticity Index for Exercise

**Time Frame:** Change from baseline to post-treatment (week 4)

**Description:** 1 item. 1-8 scale.

**Measure:** Real Self Overlap Scale

**Time Frame:** Change from baseline to post-treatment (week 4)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18 years of age or older.
* English language proficiency.
* Able and willing to give informed consent.

Exclusion Criteria:

* Does not have email address or access to email.
* Not able/willing to participate in and/or complete the pre-treatment assessments

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Berkeley

**Country:** United States

**Facility:** University of California at Berkeley

**State:** California

**Zip:** 94720-1650

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, Berkeley

**Name:** Allison Harvey, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of California, Berkeley

**Name:** Eli S Susman, BA

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
